1. Introduction
Stroke is currently a major public health and quality of life (QoL) problem, and its incidence is increasing every day. In the last 3 decades the incidence has increased by 70%, its prevalence by 85% and consequently the mortality derived from a cardiovascular accident has increased in the last 30 years by 43% [
1]. The vast majority of strokes are attributed to risk factors such as high systolic blood pressure, high body mass index, high fasting plasma glucose concentrations, environmental pollution and smoking. According to the World Stroke Organization (WSO), there are 12.2 million new strokes each year, which means that a stroke occurs every 3 seconds anywhere in the world. Since 1990, the number of people who have to live with the after-effects of a stroke has doubled to a staggering 101 million people. 1 out of every 4 inhabitants will have a stroke in their lifetime, that is why knowing how to treat the aftermath of the disease is essential to improve the QoL of people suffering from this disease [
2].
These side effects largely involve the upper limbs, being a major cause of long-term disability [
3]. These sequelae resulting from a stroke can be significant in terms of upper limb function loss. This loss not only affects mobility but also fine and gross motor skills, impacting the ability to perform activities of daily living (ADLs) such as dressing, feeding, or grooming. Fine motor skills, like the ability to grasp small objects, write, or perform other instrumental activities of daily living (IADLs), are compromised due to muscle weakness or lack of coordination. On the other hand, gross motor skills related to larger and more complex movements may also be limited, affecting the capacity to engage in various activities and task.
Another important sequelae that can be observed is “learned non-use”, a common response after a stroke. In this case, the individual avoids using the affected upper limb due to motor difficulties or weakness. This behavior develops when the person overly relies on the unaffected limb to perform daily tasks, resulting in a lack of stimulation and use of the paralyzed limb. Additionally, autonomy is another characteristic that is also affected after a stroke. Those experiencing severe stroke sequelae may heavily depend on caregivers or therapists to carry out ADLs. This directly affects their independence, subsequently influencing their QoL, as limitations in upper limb function can hinder their participation in social, recreational, and work-related activities [
4].
Rehabilitation after a stroke is essential to promote optimal recovery and improve patients’ QoL. The importance lies in implementing a comprehensive approach with a complete strategy to address the various sequelae that arise after a stroke. Additionally, personalized treatment tailored to the unique needs and challenges of each individual is crucial.
To achieve this, the need for both pre- and post-treatment assessments to objectively measure the outcomes is emphasized. In this regard, various assessment tools for stroke patients provide data on upper limb function, fine and gross motor skills, such as the Action Research Arm Test (ARAT) or Box and Blocks Test (BBT), the use of the affected upper limb compared to its pre-stroke condition using the Motor Activity Log (MAL-30), the level of autonomy using the Functional Independence Measure-Functional Assessment Measure (FIM-FAM), and their QoL through the Stroke-Specific Quality of Life Scale (SS-QoL) [
5,
6,
7,
8,
9,
10].
In rehabilitation, evidence-based therapies play a crucial role as they are supported by studies and results confirming their effectiveness in improving functionality, restoring autonomy, and enhancing the QoL of these individuals. Examples of such therapies include Mirror Therapy (MT), Cognitive Therapeutic Exercise (CTE), and task-oriented training (TOT) [
11].
MT is a rehabilitation technique employing visual illusions to enhance motor function in individuals who have experienced strokes or limb injuries. This therapy utilizes a mirror to create an illusion of normalcy in the affected limb [
12]. The mirror reflects the unaffected limb while the affected one remains hidden behind it. By moving the healthy limb, its reflection creates the appearance of movement in the affected limb, tricking the brain into perceiving normal motion. MT focuses on repetitions of controlled and specific movements, stimulating neuroplasticity—the brain’s ability to reorganize and adapt through experience and repeated practice. This therapy is believed to aid in restoring motor function, improving coordination, and reducing chronic pain associated with the affected limb [
13,
14,
15].
CTE, also known as the Perfetti method, is a neurorehabilitation approach providing tailored and specific treatment for each patient. Its goal is to recover lost or altered movement due to central nervous system damage. It involves assigning the patient the task of solving a specific problem that can be addressed through fragmented movement of body segments, assisted by the therapist. This method aims to improve the specific motor deficits in the hemiplegic upper limb, working with patterns such as abnormal responses to stretching, abnormal radiation, motor mobility of basic schemes, and promoting the effectiveness and quality of muscle activation. Its focus lies in reactivating and strengthening the neural connections damaged by stroke [
16,
17,
18].
On the other hand, TOT can be beneficial for these patients, representing an effective method to foster and develop motor skills and brain plasticity through the repetition of specific and practical tasks. This approach is based on carrying out adapted activities and tasks that simulate everyday actions. Professionals design personalized training programs, taking into account individual needs, motor deficits, and each patient’s recovery goals. These programs focus on activities that replicate the actions required for the individual’s daily routines. The effectiveness of TOT lies in its emphasis on functionality and the practical application of motor skills in real-life situations. Its purpose isn’t just to restore motor function but also to enhance the patient’s autonomy in daily activities, which can have a significant impact on their QoL [
19,
20,
21].
Lastly, it’s important to emphasize that in rehabilitation, prioritizing the optimization of treatment outcomes is essential. Therefore, combining various therapies or therapeutic approaches can help improve treatment effectiveness and expedite recovery. Recent research has demonstrated that the combination of these therapies activates central nervous system neuroplasticity more effectively than when applied separately, potentially enhancing motor function, autonomy level, and QoL of stroke patients [
22,
23,
24,
25]. Despite this, to date, no article has been published comparing which of these combined therapies, namely MT or CTE combined with TOT, is more effective in improving upper limb function after a stroke. Hence, this study aims to verify the effectiveness of combining these techniques on the overall motor function of the affected upper limb, fine and gross motor skills, use of the affected arm, and the QoL of stroke patients. The goal is to determine which of these combinations yields better results.
2. Materials and Methods
2.1. Study Design and Population
A multicenter and longitudinal study was conducted in collaboration with the University Hospital of Burgos (HUBU), the San Juan de Dios Hospital (Burgos), the Reina Sofía Hospital in Córdoba, and the University of Burgos (Spain). The study included 120 stroke patients.
The following criteria were established for the inclusion of participants in the study: (1) having a diagnosed residual hemiparesis due to an ischemic or hemorrhagic stroke, (2) having a level of mobility in the affected upper limb within stages II and IV of the Brunnstrom scale [
26], (3) obtaining a score equal to or higher than 26 on the Montreal Cognitive Assessment (MoCA) [
27,
28], (4) being over 18 years old, and (5) signing the informed consent.
Exclusion criteria, based on diagnostic information provided by the neurologist’s clinical evaluation, were as follows: (1) having a visual deficit or homonymous hemianopsia, (2) having Wernicke’s or mixed aphasia, and (3) having hemineglect.
2.2. Procedure
The participants for this study were selected upon discharge from the Stroke Unit and the Neurology Service of both hospitals, using a consecutive selection method. To determine the required sample size, an adjusted formula for finite populations was applied, considering the known proportion of strokes in the population according to data from the National Institute of Statistics (INE) [
29], with a 1% margin of error. This calculation indicated that the sample should consist of 81 stroke patients.
The study design was a randomized, controlled, and blinded clinical trial with three groups: one control group (CG) and two intervention groups (intervention 1 and intervention 2).
Participants were recruited by the rehabilitation doctor, who assessed whether they met the study’s inclusion criteria. They were randomly assigned to groups through a masking process in a 1:1:1 ratio, centrally generated by an independent researcher using Epidat 4.2 (free-access software for epidemiological analysis that allows random assignment), before participant inclusion. Different researchers administered therapies in the experimental groups (GEs). The professionals responsible for implementing therapies in different centers were Occupational Therapists and Physiotherapists specialized and trained in the techniques used.
Participants were initially evaluated one month after the stroke, applying the inclusion and exclusion criteria. Data collection began after collaboration with participating centers.
During the intervention, which extended over 20 sessions for 5 days a week [
30,
31,
32], the groups were divided so that participants in group EG1 received MT combined with TOT, while participants in group EG2 received CTE combined with TOT. Therapies were distributed in segments, dedicating 30 minutes to MT or CTE, and the remaining 30 minutes to TOT. Thus, all three groups followed their usual therapy as prescribed by the rehabilitation doctor. The GC received an additional 20 treatment sessions where MT and CTE were applied, respectively. Therapy was administered in the mentioned hospitals by occupational therapists or physiotherapists.
The research plan received approval from the IR Approval Committee of HUBU 2134/2019. Data collection was carried out in participating centers by designated personnel, and the data were anonymized before being shared with the research team, maintaining anonymity and confidentiality from that moment onward.
2.3. Instruments
Independent variables were collected covering sociodemographic data such as age and gender, as well as lifestyle habits like smoking and participation in physical activity. Additionally, general clinical variables were gathered, including the presence of hypertension (HTA), dyslipidemia, atrial fibrillation, a history of myocardial infarction, or diabetes mellitus (DM). Specific clinical variables post-stroke were also taken into account, such as the affected and dominant side, as well as the functionality of the upper limbs.
ARAT, a measure translated into Spanish and validated in the Spanish stroke population [
6], was used. It describes the ability to use the upper limb in activities requiring grip, pressure, and gross movements for everyday tasks. These aspects are crucial for performing Activities of Daily Living (ADL). Inability to perform elements of the test is considered a valid indicator of upper limb limitation for activity [
33].
The test consists of 19 items requiring manipulation and movement of objects, starting with the less affected upper limb. It is divided into 4 subscales (grasp, grip, pinch, and gross movement). Scores range on an ordinal scale from 0 to 3 for each upper limb separately, where 0 represents an inability to complete the test, and 3 indicates normal performance. Total possible scores range from 0 to 57 [
34].
This scale is suitable for use in individuals who have experienced a stroke and is considered a valid and sensitive instrument for evaluating upper limb functional limitation in the early stages after a stroke (ACV). Therefore, it becomes a suitable measure for application in patients during the initial weeks following an acute stroke [
34,
35].
BBT. was also utilized, which is a simple measure used to assess gross motor skills in patients who have suffered a stroke. The test involves moving 150 wooden blocks in one minute from one compartment to another within a divided box, first using the unaffected upper limb and then the affected one. The score is determined by manually counting the number of blocks transported correctly in that time period [
36,
37].
MAL-30. The scale, constructed from a semi-structured interview, assesses the quantity and quality of the use of the affected upper limb in the performance of Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) in individuals who have suffered a stroke. It contains 30 items in each of the quantity and quality subscales. Scores are assigned independently for each of them, ranging from 0 (the affected arm is never used for the activity) to 5 (ability to use the affected arm for this activity at the same level as before the stroke).
The sum of all scores results in a total score obtained by averaging the items responded to (it is not necessary to respond to all items, only those for which the arm was used before the stroke). Therefore, a higher score on this scale indicates better movement quality and more normalized use of the affected upper limb in performing activities. The assessment is based on the patient’s report and not on a direct evaluation of their motor function. Several studies support the robust psychometric properties of this instrument [
38,
39,
40,
41,
42]; and it is a tool translated into Spanish and validated in the Spanish population that has suffered a stroke [
5].
FIM-FAM. The Functional Independence Measure (FIM) is used to assess the level of autonomy in Activities of Daily Living (ADL). It is a global measure of disability consisting of 18 items and can be used independently or with an additional 12 items belonging to the FAM. It uses a scoring system ranging from 1 to 7, where 1 represents total dependence and 7 indicates total independence. The total possible score is 210, with a minimum score of 30 [
43,
44,
45].
SS-QoL. This instrument is a specific questionnaire designed to assess the QoL in patients who have experienced a stroke. It distinguishes itself from other questionnaires by including items addressing vision, cognition, and communication. It is applicable even to patients with ischemic or hemorrhagic stroke and motor aphasia. The Spanish version has proven to be valid, reliable, and practical.
It consists of 38 items grouped into 8 areas (physical state, communication, cognition, emotions, feelings, Activities of Daily Living, common daily life activities, and socio-family functions), with two additional questions about sexual function and work activity. The rating scale ranges from 1 to 5, where 1 represents no difficulty in performing the tasks presented, and 5 indicates extreme difficulty. This instrument is the first developed in Spanish specifically to measure the QoL in patients who have suffered a stroke [
46].
The following
Table 1 shows the instruments or scales used for measurement in this study and the variables measured by each of them.
2.4. Intervention
2.4.1. Mirror Therapy
In the course of MT treatment, the patient would be seated in a chair with forearms placed on a table, and a mirror would be positioned between both arms at a right angle to the torso. The affected limb was situated behind the mirror, outside the patient’s field of vision, in a comfortable posture. Simultaneously, the healthy limb was arranged so that its reflection in the mirror was distortion-free, ensuring the removal of any objects or symbols exclusively visible to the healthy limb.
MT was executed through three distinct modes. Initially, in the first mode, the patient endeavored to replicate the movement of the healthy hand with the affected hand in a synchronized manner. Subsequently, in the second mode, the patient envisioned themselves performing the mirrored movement of the healthy hand with the affected hand. Finally, in the third mode, the therapist aided the patient’s affected hand in mimicking the movement of the healthy hand. The exercises commenced with uncomplicated movements without objects in the initial sessions, progressed to movements involving objects in the intermediate sessions, and ultimately incorporated more intricate movements with objects in the concluding sessions. The progression was individually adapted based on the patient’s recovery, commencing with initial mental imagery and advancing to therapist-assisted execution. All exercises were executed deliberately and repeated at least 15 times, with adjustments to complexity according to each patient’s individual capacities and limitations.
2.4.2. Cognitive Therapeutic Exercise
CTE are organized into three tiers: primary, secondary, and tertiary levels. Initially, all patients participated in primary-level exercises to acquire proficiency in managing the stretching reaction, adjusting intensity, duration, and localization. Once this proficiency was attained, they advanced to secondary-level exercises. Later, tertiary-level exercises were introduced, wherein patients acquired the skill to modify movements based on perceptual hypotheses, having automated the control of abnormal secondary-grade motor behaviors.
At the primary level, the focus was on addressing excessive stretching reactions (spasticity) and diminished sensitivity, with the therapist executing movements alongside the patient. These exercises demanded the patient’s constant active attention. Moving to the secondary level, efforts were directed towards managing the involuntary activation of muscle groups (abnormal irradiation). Here, the patient executed movements with minimal therapist assistance, incorporating various tactile, kinetic, weight, grip, and friction stimuli, combined with primary-level exercises. In the tertiary level, the emphasis was placed on controlling voluntary movements, involving their fragmentation, variability, and adaptation, with the ultimate goal of achieving complete automation of movements without any therapeutic assistance from the patient.
2.4.3. Task-Oriented Training
TOT was structured sequentially, adapting in each session to simulate everyday situations. Complex activities were broken down into simpler tasks to facilitate learning. Activities included the preparation and organization of food, handling clothing (both upper and lower), and personal care, covering actions such as brushing teeth, combing hair, or shaving, and even applying makeup. Brief rest periods were interspersed, and the difficulty of tasks increased gradually to enhance their execution.
2.5. Statistical Analysis
Descriptive analyses of the sample characteristics were conducted, presenting categorical variables in absolute frequencies and percentages, and continuous variables in means and standard deviations (SD). The normality of the dataset was assessed using the Kolmogorov-Smirnov test.
To analyze differences between groups concerning various assessments conducted during the intervention, an analysis of covariance (ANCOVA) was employed. In this analysis, the treatment group to which participants belonged was considered a fixed factor, while the differential scores of the evaluated variables (such as functionality, fine and gross motor skills, level of autonomy, and QoL were used as dependent variables, with the initial values of these same variables used as covariates.
To calculate the sample size, a formula adjusted for finite populations was used. This involved taking into account a known proportion of stroke cases in the population, relying on information from the National Institute of Statistics (INE) [
29], and aiming for an estimated margin of error of 1%. Consequently, it was determined that the sample should include 81 stroke patients.
The statistical analysis was conducted using IBM SPSS Statistics version 28 (IBM Inc., Chicago, IL, USA). A significance level of p < 0.05 was considered indicative of statistical significance.
3. Results
The data were collected from 120 patients one month after suffering a stroke. The average age of these patients was 68.92 ± 11.79 years (range 41-96). The gender distribution was 58.3% for males (n=70) and 41.7% for females (n=50). Most participants were right-handed (95.8%; n=115). Additionally, an equal distribution was observed regarding the affected side, with 51.7% of participants experiencing impairment in the left upper limb (n=62) and 48.3% in the right (n=58). A similar distribution was found in relation to dominance, with 46.7% (n=56) of individuals showing a match between the affected upper limb and dominance, while 53.3% (n=64) did not match.
Regarding the diagnosed stroke type, the vast majority were cases of ischemic stroke (92.5%; n=111), while a smaller proportion corresponded to hemorrhagic strokes (6.7%; n=8).
Table 2 provides some clinical variables of the sample.
Similarly, the distribution among the groups was 33.3% (n=40) for each, i.e., the CG, the MT group, and the CTE group.
Table 2 shows the differences found in the analysis between the treatment groups and the differential scores obtained between the first and second evaluation in the functionality of the affected upper limb, fine and gross motor skills, quantity and quality of use of the affected upper limb, autonomy, and QoL of stroke patients.
Statistically significant differences were obtained for all of them in functionality and gross and fine motor skills of the affected upper limb measured with ARAT (F(2.116)= 13.513. p<0.001; ƞ2p= 0.189) and BBT (F(2.116)= 10.741. p<0.001; ƞ2p= 0.156), the quantity and quality of use of the affected upper limb compared to the pre-stroke situation (F(2.116)= 9.850. p<0.001; ƞ2p= 0.254 and F(2.116)= 6.143. p=0.003; ƞ2p= 0.096), level of autonomy (F(2.116)= 5.288. p=0.006; ƞ2p= 0.084), and QoL (F(2.116)= 7.331. p<0.001; ƞ2p= 0.112).
Significant or highly significant differences are observed between the CG scores and the two GEs ps in all evaluated variables. However, no statistically significant differences are observed between the two GEs.
In
Table 3, the differences found in the analysis between the treatment groups and the differential scores obtained between the first and third evaluation in the functionality of the upper limb, fine and gross motor skills, quantity and quality of use of the affected upper limb, autonomy, and QoL in stroke patients are observed.
Statistically significant differences were obtained for the functionality and gross and fine motor skills of the affected upper limb measured with ARAT (F(2.116)= 8.138. p<0.001; ƞ2p= 0.123) and BBT (F(2.116)= 11.987. p<0.001; ƞ2p= 0.171), the quantity and quality of use of the affected upper limb compared to the situation before the stroke (F(2.116)= 7.978. p<0.001; ƞ2p= 0.121 and F(2.116)= 8.958. p<0.001; ƞ2p= 0.134), and QoL (F(2.116)= 10.244. p<0.001; ƞ2p= 0.150).
However, no statistically significant differences were observed in the functionality and fine and gross motor skills of the right affected upper limb measured with the BBT (F(2.116)= 1.674. p=0.197; ƞ2p= 0.058), nor for autonomy (F(2.116)= 2.088. p=0.129; ƞ2p= 0.035).
Similar to
Table 2, significant or highly significant differences are observed between the scores of the CG and the two GEs in all the aforementioned significant variables, but not between the two GEs.
4. Discussion
The aim of this study was to assess the effectiveness of combined MT and CTE with TOT in patients with acute stroke regarding the functionality of the affected upper limb, fine and gross motor skills, the quantity and quality of the affected limb’s use, autonomy, and QoL.
Our results demonstrate a significant improvement in scores after the application of complementary treatment, between the first and second assessment, following 20 sessions of MT or CTE combined with TOT in the GEs compared to the CG, which received only standard therapy. In addition to the differences found between scores obtained in the first and second assessments, statistically significant differences are also observed between the GEs and the CG in the differential scores between the first and third assessments. This indicates that the GEs showed a superior improvement in all analyzed variables, without significant differences between them. Statistically significant improvements are also evident in our results when considering long-term scores. Comparing scores between the first assessment and the third, i.e., 3 months after the second assessment or the intervention’s completion, statistically significant differences can be observed for the measured variables. In addition to finding significant improvement, it appears that the improvements achieved are maintained in the long term.
Statistically significant differences are observed for the functionality and fine and gross motor skills of the affected upper limb, measured with the ARAT and BBT scales (p<0.001), the quantity of use of the affected upper limb compared to the pre-stroke situation (p<0.001), and QoL (p<0.001). Other studies employing the same assessment instruments also suggest that MT intervention is beneficial for improving the motor functionality of the right upper limb, with MT being more effective than other therapies [
47,
48,
49]. This may be attributed to the visual stimulation provided to the hemiplegic upper limb through the reflection of the normal side, which, in turn, stimulates the cerebral cortex and spinal area, replacing the lost proprioceptive sense. Additionally, it activates mirror neurons when observing, imagining, or attempting to execute movements [
50].
Furthermore, QoL in the GEs is higher than in the CG. These results align with other studies indicating that applying MT and CTE treatment improves QoL [
48], or even that any form of intervention, regardless of the therapy, significantly enhances QoL [
19,
51]. It is noteworthy that low functionality of the affected upper limb is the primary predictor of low QoL [
52]. Statistically significant differences were also observed for the variables of quality of use of the affected upper limb compared to the pre-stroke situation (p=0.003) and the level of autonomy (p=0.006). These results are also supported by previous research, where a physical exercise intervention program improved motor capacity and functionality, in addition to enhancing levels of self-confidence, motivation, and subjective perception of effort towards performing daily life tasks that involved active participation and muscle group engagement [
47,
48,
49,
50]
Similarly, statistically significant differences are observed between the two GEs and the CG, showing a superior improvement in both GEs compared to the CG. However, no statistically significant differences were found between the two GEs where TOT was combined with MT and CTE. Therefore, it seems that engaging in physical activity with the aim of recovering mobility and functionality of the affected limb, regardless of its nature, is better than implementing a more austere program based on the non-application of physical exercise to avoid functional discomfort and patient discomfort, as advanced by the majority of the scientific literature on this topic [
50,
51,
52].
As seen, there are significant differences in the quantity and quality of the use of the affected upper limb compared to the pre-stroke situation. This is supported by other studies indicating that after a stroke, many patients continue to use their affected upper limb in ADL in addition to its use in therapy, achieving normal performance [
53]. However, it is worth noting that, to the best of the authors’ knowledge, there is no study to date that has considered whether the affected limb coincides with the patient’s dominant limb. Applying logic based on findings from investigations in other scientific fields, such as those analyzing the effects of the same training load on muscle performance in the dominant and non-dominant limb, it could be that patients whose affected limb coincides with their dominant limb obtain greater functional benefits and motor competence than those where the affected and dominant limbs do not coincide. Alternatively, training on the non-affected limb may stimulate gains or prevent losses in neuromotor recruitment on the affected limb [
54,
55,
56,
57,
58]. However, future research should develop and confirm this research hypothesis.
The study presents certain limitations, such as the small sample size, which hinders the extrapolation of results. It would be beneficial to expand the sample to improve representativity. Additionally, slightly adjusting the inclusion and exclusion criteria could facilitate participant selection, as recruitment was hindered by the difficulty in finding patients who met all the proposed criteria. Furthermore, the study’s initiation before the pandemic made recruitment challenging over an extended period, and many recruited patients experienced the pre-COVID period or interrupted treatments due to infection, which could have influenced the results in some way. Similarly, the clinical context in which the study was conducted may limit the extrapolation of results to other contexts.
Some future lines of research that could be pursued include long-term follow-up of patients to better understand how initial improvement translates into longer-term outcomes. Combined interventions with other therapeutic methods could be implemented and compared to observe improvements or effectiveness. The study could include additional emotional variables that may influence the relationship between motor skills, functional outcomes, autonomy, or QoL, such as cognitive ability, emotional status, or social participation.
5. Conclusions
In conclusion, our results have demonstrated the effectiveness of combining MT and CTE techniques simultaneously with TOT to improve functionality of the affected upper limb, fine and gross motor skills, the quantity and quality of use of the affected upper limb compared to the pre-stroke situation, autonomy, and QoL.
Furthermore, a significant improvement was observed for all variables following the completion of treatment and sometime thereafter, suggesting that the majority of the achieved improvements persist beyond the treatment period.
However, it can also be concluded that both techniques yield positive results for the improvement of the variables used in the study. Both MT and CTE have shown significant results for all variables, with no significant differences between the GEs. Therefore, both MT and CTE, along with their combination with TOT, are suitable choices for addressing functionality, fine and gross motor skills, the use of the upper limb, autonomy, and QoL in the acute and subacute phases of patients who have suffered a stroke.
Author Contributions
The following statements should be used “Conceptualization. J.F.-S. and M.S.-P.; methodology. J.J.G.-B. and J.G.-S.; software. J.F.-S. and M.S.-P.; validation. J.F.-S. and M.S.-P.; formal analysis. S.A.-P. and A.M.-V.; investigation. J.F.-S., J.G.-S. and R.V.-S.; resources. S.A.-P. and R.V.-S.; data curation. J.F.-S.; writing—original draft preparation. S.A.-P., A.M.-V. and R.V.-S.; writing—review and editing. S.A.-P., A.M.-V. and R.V.-S.; visualization. J.F.-S. and J.J.G.-B.; supervision. M.S.-P. and J.G.-S.; project administration. J.J.G.-B. and J.G.-S. All authors have read and agreed to the published version of the manuscript.”
Funding
This research received no external funding.
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the University Hospital of Burgos (HUBU 2134/2019, 25 June 2019).
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
Conflicts of Interest
The authors declare no conflict of interest.
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Table 1.
Clinical variables of the sample.
Table 1.
Clinical variables of the sample.
Used scales |
Variables measured |
ARAT |
Functionality, fine motor skills, and gross motor skills |
BBT |
Functionality, fine motor skills, and gross motor skills |
MAL-30 |
Quantity and quality of use of the affected arm |
FIM-FAM |
Autonomy |
SS-QoL |
Quality of life |
Table 2.
ANCOVA analysis between the treatment group and the first-second evaluation.
Table 2.
ANCOVA analysis between the treatment group and the first-second evaluation.
Variables |
Group |
First evaluation mean (SD) |
Second evaluation mean (SD) |
Treatment group |
Mean difference |
SD |
P |
95% CI |
Observed power |
LI |
LS |
Functionality, fine motor skills, and gross motor skills (ARAT) |
CG |
38.13 (22.129) |
35.58 (24.552) |
CTE |
-10.537 |
2.738 |
<0.001** |
-15.960 |
-5.114 |
0.998 |
MT |
-13.613 |
2.735 |
<0.001** |
-19.029 |
-8.197 |
CTE |
29.15 (20.482) |
38.45 (19.833) |
CG |
10.537 |
2.738 |
<0.001** |
5.114 |
15.960 |
MT |
-3.076 |
2.694 |
0.256 |
-8.413 |
2.260 |
MT |
29.50 (18.902) |
41.83 (18.940) |
CG |
13.613 |
2.735 |
<0.001** |
8.197 |
19.029 |
CTE |
3.076 |
2.694 |
0.256 |
-2.260 |
8.413 |
Functionality, fine motor skills, and gross motor skills (BBT) |
CG |
25.08 (24.091) |
26.50 (24.496) |
CTE |
-5.473 |
2.050 |
0.009* |
-9.533 |
-1.412 |
0.989 |
MT |
-9.380 |
2.030 |
<0.001** |
-13.401 |
-5.359 |
CTE |
16.80 (14.141) |
23.93 (15.562) |
CG |
5.473 |
2.050 |
0.009* |
1.412 |
9.533 |
MT |
-3.907 |
2.021 |
0.056 |
-7.910 |
0.095 |
MT |
19.80 (15.955) |
30.75 (19.454) |
CG |
9.380 |
2.030 |
<0.001** |
5.359 |
13.401 |
CTE |
3.907 |
2.021 |
0.056 |
-0.095 |
7.910 |
Quantity of use of the affected arm (MAL-30) |
CG |
2.39 (2.173) |
2.51 (2.221) |
CTE |
-0.471 |
0.264 |
0.077 |
-0.995 |
0.052 |
0.930 |
MT |
-1.001 |
0.263 |
<0.001** |
-1.523 |
-0.480 |
CTE |
1.92 (1.955) |
2.64 (1.479) |
CG |
0.471 |
0.264 |
0.077 |
-0.052 |
0.995 |
MT |
-0.530 |
0.264 |
0.047* |
-1.052 |
-0.008 |
MT |
2.19 (2.012) |
3.37 (1.845) |
CG |
1.001 |
0.263 |
<0.001** |
0.480 |
1.523 |
CTE |
0.530 |
0.264 |
0.047* |
0.008 |
1.052 |
Quality of use of the affected arm (MAL-30) |
CG |
2.33 (2.149) |
2.52 (2.270) |
CTE |
-0.378 |
0.261 |
0.151 |
-0.895 |
0.140 |
0.882 |
MT |
-0.906 |
0.260 |
0.001** |
-1.421 |
-0.391 |
CTE |
1.75 (1.753) |
2.46 (1.466) |
CG |
0.378 |
0.261 |
0.151 |
-0.140 |
0.895 |
MT |
-0.529 |
0.260 |
0.044* |
-1.043 |
-0.015 |
MT |
1.99 (1.911) |
3.16 (1.788) |
CG |
0.906 |
0.260 |
0.001** |
0.391 |
1.421 |
CTE |
0.529 |
0.260 |
0.044* |
0.015 |
1.043 |
Autonomy (FIM-FAM) |
CG |
135.60 (63.501) |
141.00 (61.624) |
CTE |
-4.530 |
4.287 |
0.293 |
-13.020 |
3.960 |
0.827 |
MT |
-13.558 |
4.262 |
0.002* |
-21.999 |
-5.118 |
CTE |
156.70 (33.636) |
167.88 (28.886) |
CG |
4.530 |
4.287 |
0.293 |
-3.960 |
13.020 |
MT |
-9.028 |
4.215 |
0.034* |
-17.377 |
-0.679 |
MT |
152.73 (35.814) |
169.65 (27.023) |
CG |
13.558 |
4.262 |
0.002* |
5.118 |
21.999 |
CTE |
9.028 |
4.215 |
0.034* |
0.679 |
17.377 |
QoL (SS-QoL) |
CG |
105.53 (37.989) |
100.58 (37.043) |
CTE |
1.618 |
3.411 |
0.636 |
-5.138 |
8.375 |
0.993 |
MT |
11.957 |
3.386 |
0.001** |
5.251 |
18.663 |
CTE |
96.03 (26.105) |
90.88 (28.987) |
CG |
-1.618 |
3.411 |
0.636 |
-8.375 |
5.138 |
MT |
10.338 |
3.406 |
0.003* |
3.593 |
17.084 |
MT |
104.48 (30.573) |
93.06 (31.292) |
CG |
-11.957 |
3.386 |
0.001** |
-18.663 |
-5.251 |
CTE |
-10.338 |
3.406 |
0.003* |
-17.084 |
-3.593 |
Table 3.
Analysis of Covariance (ANCOVA) between the treatment group and the first-third evaluation.
Table 3.
Analysis of Covariance (ANCOVA) between the treatment group and the first-third evaluation.
Variables |
Group |
First evaluation mean (SD) |
Third evaluation mean (SD) |
Treatment group |
Mean difference |
SD |
P |
95% CI |
Observed power |
LI |
LS |
Functionality, fine motor skills, and gross motor skills (ARAT) |
CG |
38.13 (22.129) |
36.75 (24.330) |
CTE |
-10.067 |
2.827 |
<0.001** |
-15.667 |
-4.467 |
0.994 |
MT |
-13.315 |
2.824 |
<0.001** |
-18.908 |
-7.722 |
CTE |
29.15 (20.482) |
39.08 (21.007) |
CG |
10.067 |
2.827 |
<0.001** |
4.467 |
15.667 |
MT |
-3.248 |
2.782 |
0.245 |
-8.759 |
2.263 |
MT |
29.50 (18.902) |
42.63 (19.228) |
CG |
13.315 |
2.824 |
<0.001** |
7.722 |
18.908 |
CTE |
3.248 |
2.782 |
0.245 |
-2.263 |
8.759 |
Functionality, fine motor skills, and gross motor skills (BBT) |
CG |
25.08 (24.091) |
29.08 (24.986) |
CTE |
-12.165 |
3.144 |
<0.001** |
-18.393 |
-5.938 |
0.955 |
MT |
-9.199 |
3.113 |
0.004* |
-15.365 |
-3.033 |
CTE |
16.80 (14.141) |
34.30 (16.857) |
CG |
12.165 |
3.144 |
<0.001** |
5.938 |
18.393 |
MT |
2.966 |
3.099 |
0.341 |
-3.172 |
9.104 |
MT |
19.80 (15.955) |
33.865 (19.705) |
CG |
9.199 |
3.113 |
0.004* |
3.033 |
15.365 |
CTE |
-2.966 |
3.099 |
0.341 |
-9.104 |
3.172 |
Quantity of use of the affected arm (MAL-30) |
CG |
2.39 (2.173) |
2.73 82.327) |
CTE |
-0.690 |
0.267 |
0.011* |
-1.219 |
-0.160 |
0.951 |
MT |
-1.047 |
0.266 |
<0.001** |
-1.575 |
-0.520 |
CTE |
1.92 (1.955) |
3.08 (1.605) |
CG |
0.690 |
0.267 |
0.011* |
0.160 |
1.219 |
MT |
-0.358 |
0.267 |
0.182 |
-0.886 |
0.170 |
MT |
2.19 (2.012) |
3.64 (1.637) |
CG |
1.047 |
0.266 |
0.000 |
0.520 |
1.575 |
CTE |
0.358 |
0.267 |
0.182 |
-0.170 |
0.886 |
Quality of use of the affected arm (MAL-30) |
CG |
2.33 (2.149) |
2.61 (2.274) |
CTE |
-0.698 |
0.259 |
0.008 |
-1.211 |
-0.185 |
0.970 |
MT |
-1.076 |
0.258 |
<0.001 |
-1.586 |
-0.566 |
CTE |
1.75 (1.753) |
2.87 (1.612) |
CG |
0.698 |
0.259 |
0.008 |
0.185 |
1.211 |
MT |
-0.378 |
0.257 |
0.144 |
-0.887 |
0.132 |
MT |
1.99 (1.911) |
3.43 (1.606) |
CG |
1.076 |
0.258 |
<0.001 |
0.566 |
1.586 |
CTE |
0.378 |
0.257 |
0.144 |
-0.132 |
0.887 |
Autonomy (FIM-FAM) |
CG |
135.60 (63.501) |
152.55 (55.492) |
CTE |
-1.522 |
3.683 |
0.680 |
-8.817 |
5.773 |
0.422 |
MT |
5.510 |
3.662 |
0.135 |
-1.742 |
12.763 |
CTE |
156.70 (33.636) |
176.13 (26.296) |
CG |
1.522 |
3.683 |
0.680 |
-5.773 |
8.817 |
MT |
7.032 |
3.622 |
0.055 |
-0.142 |
14.206 |
MT |
152.73 (35.814) |
172.45 (26.345) |
CG |
-5.510 |
3.662 |
0.135 |
-12.763 |
1.742 |
CTE |
-7.032 |
3.622 |
0.055 |
-14.206 |
0.142 |
QoL (SS-QoL) |
CG |
105.53 (37.989) |
85.18 (37.332) |
CTE |
-20.768 |
5.173 |
<0.001 |
-31.014 |
-10.523 |
0.985 |
MT |
-19.570 |
5.135 |
<0.001 |
-29.739 |
-9.400 |
CTE |
96.03 (26.105) |
82.98 (27.945) |
CG |
20.768 |
5.173 |
<0.001 |
10.523 |
31.014 |
MT |
1.199 |
5.165 |
0.817 |
-9.030 |
11.428 |
MT |
104.48 (30.573) |
84.00 (27.133) |
CG |
19.570 |
5.135 |
<0.001 |
9.400 |
29.739 |
CTE |
-1.199 |
5.165 |
0.817 |
-11.428 |
9.030 |
|
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