Effectiveness of the Home-Based Graded Repetitive Arm Supplementary Program Combined With Occupational Therapy Versus Conventional Occupational Therapy Alone on Quality of Life and Upper Limb Function After Stroke: A Randomized Controlled Trial
Phase: NA
Conditions: Stroke With Hemiparesis
Sponsor: Universidad Miguel Hernandez de Elche

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Effectiveness of the Home-Based Graded Repetitive Arm 
Supplementary Program Combined with Occupational 
Therapy Versus Conventional Occupational Therapy Alone 
on Quality of Life and Upper Limb Function After Stroke: A 
Randomized Controlled Trial 
 
NCT ID not yet assigned 
 
 
 
Version 1.1 April 2025 
 

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Effectiveness 
of 
the 
Home-Based 
Graded 
Repetitive 
Arm 
Supplementary Program Combined with Occupational Therapy 
Versus Conventional Occupational Therapy Alone on Quality of Life 
and Upper Limb Function After Stroke: A Randomized Controlled Trial  
 
State of art 
Stroke is a sudden injury that transiently or permanently impairs certain brain 
functions depending on the affected area. Depending on the location and extent of 
the lesion, individuals may experience a range of impairments, including motor, 
cognitive, or perceptual deficits1. Among sensorimotor impairments, loss of upper 
limb functionality on the affected side is one of the greatest rehabilitation challenges. 
At least 80% of people who suffer a stroke experience some form of impairment in 
their upper limb, while only 15% achieve significant functional recovery. Since our 
arms and hands are essential for performing many activities of daily living (ADLs), 
any functional limitation can lead to loss of independence in these tasks, potentially 
resulting in disability2. 
 
Recent studies have shown that the rehabilitation time dedicated to the upper limb 
is insufficient3. Increasing the intensity of therapy compared to standard 
rehabilitation can improve outcomes, especially in the chronic phase4. To increase 
intensity, strategies include longer therapy sessions and promoting a higher number 
of repetitions to support motor learning and the generalization of acquired skills. 
Technological advancements—such as robotics and virtual reality—are used to 
intensify home-based rehabilitation, ensuring patient follow-up and enabling a high 
volume of practice. However, these technologies often imply additional costs for 
patients or neurorehabilitation centers, which can hinder implementation5. In some 
cases, due to their complexity or the digital divide among older adults, acquiring or 
adhering to such treatments may be difficult. A practical solution to this challenge is 
to incorporate home-based exercises to extend rehabilitation time while minimizing 
economic barriers6. Over the years, home exercise approaches have evolved from 
unsupervised routines and written instructions to technology-assisted programs. 
 
The Home Graded Repetitive Arm Supplementary Program (Home-GRASP)7 is a 
home-based exercise program supervised by an occupational therapist. It was 
developed by a neurorehabilitation team at the University of British Columbia in 
Canada (https://neurorehab.med.ubc.ca/grasp/). The program consists of a booklet 
with 33 exercises targeting various aspects of upper limb rehabilitation, including 
stretching, strengthening of the arm and hand, coordination, and fine motor skills. 

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The program adopts an individualized approach where the patient, either 
independently or with the assistance of a caregiver, performs a set of exercises 
prescribed by the occupational therapist. Prior to implementation, the therapist 
conducts an in-person session at the rehabilitation center to explain each exercise 
thoroughly and address any questions. During this session, the patient also receives 
all the materials needed to carry out the program at home. To ensure proper follow-
up, patients are asked to maintain a daily activity log, recording the number of sets 
and repetitions performed for each exercise, perceived difficulty, and any relevant 
observations. These logs allow for detailed monitoring and are reviewed weekly by 
the occupational therapist, who evaluates progress and adjusts the program as 
needed. In addition to reviewing the logs, the therapist collects verbal feedback 
during weekly follow-up sessions to address questions or difficulties with exercise 
execution. As part of the ongoing monitoring process, a Visual Analogue Scale (VAS) 
is used to assess the presence of pain in the affected arm or hand. Based on the 
information gathered, the therapist may increase or decrease the intensity or 
difficulty of the exercises—for example, by increasing the number of repetitions, 
using objects that are harder to manipulate, or introducing heavier weights. The 
HomeGRASP program is designed to be performed for 1 hour per day, 7 days a week, 
over a total period of 8 weeks. This program offers several advantages over 
previously proposed options. It adds seven additional hours of upper limb 
rehabilitation per week, supervised by a healthcare professional, and incorporates 
task-oriented training and strengthening exercises—approaches that promote a high 
number of repetitions and have demonstrated effectiveness in upper limb 
rehabilitation. Finally, it stands out for its ease of use, free and open access to the 
exercise manual available on the University of British Columbia’s website 
(https://neurorehab.med.ubc.ca/grasp/), and the fact that the materials required to 
carry out the program are easily obtainable, without the need to purchase them from 
specialized medical supply stores. 
 
To date, 19 studies have been conducted on the GRASP program9-27. A qualitative 
study explored the experience of carrying out the GRASP program in hospitalized 
patients during the first weeks after suffering a stroke9. Other studies have been 
conducted in the chronic phase after stroke, while participants were receiving 
outpatient treatment, or after completing their formal rehabilitation and continuing 
the program exclusively at home10-11. Among them, there is only one multicenter 
study comparing the GRASP program with a control group that only received 
information about stroke rehabilitation and general health. These studies conclude 
that using the GRASP program improves upper limb functionality and use after a 

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stroke13. One study combined GRASP with transcranial magnetic stimulation13, 
comparing it with a control group that performed only GRASP. Both groups showed 
improvements in the functionality of the affected upper limb, but no significant 
differences were found between the groups at the end of the intervention. However, 
at a one-month follow-up, the group that received GRASP in combination with 
transcranial magnetic stimulation did show significant differences compared to the 
GRASP-only group. A comparative study was also conducted with constraint-induced 
movement therapy (CIMT)14 in patients in the acute phase after stroke. Both 
approaches require a minimum level of prior mobility in the affected arm and hand 
to be applied appropriately. In this study, the group that performed the GRASP 
program showed significantly better improvements than the CIMT group. 
One study compared the use of home-based rehabilitation software through tablets 
versus GRASP15. The tablet-based device showed greater improvements in both 
cognitive and sensorimotor recovery of the affected upper limb. However, in that 
study, the GRASP group only performed the program 30 minutes per day (instead of 
the recommended 1 hour) and 3–4 days per week (instead of 7 days per week). 
Another study compared the GRASP program with a home-based virtual reality 
program16, but no statistically significant differences were found. One study added 
software for detecting compensatory upper limb movements using Kinect, providing 
real-time feedback to the patient during home-based execution of the program, 
allowing for immediate correction of compensations17. 
Four studies have proposed future comparative trials with GRASP. The first explores 
the combination of transcranial electrical stimulation with GRASP versus GRASP 
alone18. Another compares a lower limb exercise program (PREP) versus PREP 
combined with GRASP19. A third proposes a home-based music therapy program 
versus GRASP20. The fourth will compare a Chinese calligraphy program with 
GRASP21. Results of these four studies have not yet been published. 
 
The program’s inclusion in community settings22 has been explored, along with the 
possibility of remote follow-up via video calls or phone calls23-24, showing good 
adherence among participants through telematic monitoring. 
Surveys have been conducted with occupational therapists in Vancouver25 and the 
UK26 to assess their knowledge of GRASP and its use in daily practice. These studies 
show that only 22% of surveyed therapists were familiar with the GRASP program 
and 36% had never heard of it. Finally, in 2023, a bibliometric study was conducted 
to assess the impact and use of the GRASP program in the rehabilitation process, 
identifying a total of 15 publications available up to that year27. 
 

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To date, no trial has compared conventional treatment combined with the GRASP 
program versus conventional treatment alone. Based on the above, the 
implementation of the program in Spain is proposed, aiming to assess changes in 
perceived quality of life and upper limb functionality as primary outcomes. 
Additionally, manipulative skills, upper limb use in activities of daily living (ADLs), 
and personal autonomy will be evaluated as secondary outcomes. All of this will be 
carried out through the HomeGRASP program as a complement to conventional 
occupational therapy rehabilitation. 
 
General Objective: To evaluate changes in quality of life and motor function in stroke 
patients participating in the HomeGRASP home-based rehabilitation program 
combined 
with 
conventional 
occupational 
therapy, 
compared 
to 
standard 
conventional occupational therapy treatment. 
Specific Objectives: 
1) To assess improvement in the motor function of the affected upper limb in the 
intervention group using the Wolf Motor Function Test (WMFT), in comparison 
with the control group. 
2) To measure changes in perceived quality of life in both groups using the 
CAVIDACE scale, in order to identify differences in emotional, social, and 
physical well-being. 
3) To analyze the type of exercises performed and the time dedicated to home 
rehabilitation in the intervention group. 
4) To evaluate adherence to the HomeGRASP home rehabilitation program and 
the intensity of physical activity using accelerometry, comparing the 
intervention and control groups. 
5) To compare performance in gross motor tasks of the affected upper limb using 
the Box and Block Test (BBT), to assess improvements in unimanual dexterity. 
6) To assess unimanual and bimanual dexterity through the Purdue Pegboard 
Test (PPT), analyzing improvements in coordination and manual skills between 
both groups. 
7) To measure the quantity and quality of use of the affected upper limb during 
daily activities using the Motor Activity Log-30 (MAL), to determine whether 
the HomeGRASP program enhances participation and use of the affected limb 
compared between groups. 
8) To evaluate changes in difficulty performing activities of daily living (ADLs) in 
both groups using the Duruöz Index (DI). 

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9) To assess functional independence in both groups using the Functional 
Independence Measure (FIM), to determine whether the experimental 
program contributes to greater independence in everyday tasks. 
10) To assess the impact of pain in both groups using the Visual Analog Scale 
(VAS), to determine whether the HomeGRASP program helps reduce pain 
associated with rehabilitation activities. 
11) To describe treatment adherence in the HomeGRASP group, and to identify 
barriers and facilitators to participation in the program. 
 
Methodology 
Study Design: This will be a single-blind, parallel-group randomized clinical trial, in 
which participants will be randomly assigned to one of two groups: an intervention 
group or a control group. 
• 
Control group: This group will only receive conventional occupational 
therapy treatment at the rehabilitation center. The standard treatment will 
typically consist of 2–3 sessions per week, each lasting 45 minutes. The 
approaches used during the sessions will be based on mobilisation of the 
affected upper limb only if necessary (maximum 10 minutes of the session), 
task-oriented training and ADL training. 
• 
Experimental group: will carry out the conventional treatment previously 
described in the control group together with the HomeGRASP programme at 
home. This programme has a duration of one hour of exercises at home, seven 
days a week, over a period of eight weeks. As the programme involves 
supervision by the occupational therapist of the exercises performed at home, 
20-30 minutes of the conventional session will be devoted to reviewing this 
plan. Prior to the start of the programme, an explanatory session will be held 
with the patient and, if necessary, with the caregiver to show and teach the 
correct performance of the exercises proposed in the programme, as well as 
the delivery of the material necessary to carry them out. 
 
Randomisation: Participants will be randomised after receiving detailed information 
about the study, signing the informed consent form, and completing the baseline 
assessment. To ensure comparability between groups and reduce the risk of 
allocation imbalance, a block randomisation method with a 1:1 allocation ratio will be 
used, employing blocks of 6 participants. The randomisation will be performed using 
the blockrand package in the R statistical software. This procedure will be carried out 

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by an independent researcher who will not be involved in the assessments or 
interventions, ensuring the impartiality of the process. 
 
Blinding: The study will be single-blinded to the evaluator who will be a person 
outside the group allocation. To minimise systematic bias due to non-blinding, 
participants will be instructed not to inform the evaluators of the group assignment 
they received. Likewise, prior to data analysis, the thesis supervisor will carry out a 
reassignment of codes so that the PhD student does not know the group in which the 
person participated. 
Study population and sample: The study population includes patients who have 
suffered a stroke who are treated as outpatients in neurological rehabilitation centres. 
The study population will be all persons who have suffered a stroke who meet the 
following inclusion and exclusion criteria. 
Inclusion criteria: 
• 
Being of legal age. 
• 
Having suffered only one stroke event and being clinically stable. 
• 
At least 3 months after the stroke and less than 12 months. 
• 
Signed informed consent. 
• 
Be able to report any harmful effects (e.g. shoulder pain). 
• 
Be able to follow instructions and perform the exercises independently for one 
hour. If unable to do so, be assisted by a caregiver to ensure completion of 
the exercises. 
• 
Perform at least 10º of active wrist or finger extension. 
• 
Ability to lift the scapula of the affected upper limb against gravity. 
Exclusion criteria: 
• 
Having other neurological conditions other than stroke. 
• 
Excessive pain in the affected upper limb that prevents him/her from correctly 
performing the exercises proposed in the programme. Visual Analogue Scale 
(VAS > 7). 
• 
Visual perception deficit that prevents him/her from correctly performing the 
exercises proposed in the programme. 
• 
Excessive muscle tone (spasticity or hypertonia) that prevents him/her from 
correctly performing the exercises proposed in the programme. Asworth > 2. 
• 
A Folstein Mini Mental State Examination (MMSE) score ≥22 is required. 
 
The study sample will be selected from Hermanas Hospitalarias neurological 
rehabilitation centres from among people attending outpatient treatment who meet 
the inclusion criteria and who do not present conditions that would lead to exclusion. 

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In the event that it is necessary to recruit more participants to reach the sample size, 
other neurorehabilitation centres in the Valencian Community will be contacted. 
 
Sample size estimation will be based on preliminary data from the first 24 
participants included in the study. For each outcome variable, the pre-post difference 
by group will be calculated, and the effect size will be estimated using Cohen's d. The 
required sample size per group will then be determined using a two-sided t-test with 
a significance level of 0.05 and 80% power, adjusting for an expected attrition rate 
derived from the proportion of missing post-intervention data observed in this initial 
subsample. This calculation will be performed using the R statistical software and the 
pwr package. 
Evaluation tools: 
- 
Primary outcomes: 
o 
Wolf Motor Function Test (WMFT)28 quantifies upper limb (UM) motor 
ability through timed and functional tasks. The tool consists of 17 items 
including 6 items involve timed functional tasks, items 7 and 14 are 
measures of strength, and the remaining 9 items consist of analysing 
the quality of movement when completing various tasks. 
o 
CAVIDACE29: is an assessment of the perceived quality of life of adults 
with brain injury from the perspective of an external evaluator. It is 
recorded by a person who knows the user well (e.g. professionals, 
relatives, legal guardians...). The sections included in this tool are: 
emotional well-being, interpersonal relationships, material well-being, 
personal development, physical well-being, self-determination, social 
inclusion and rights. 
 
- 
Secondary outcomes 
- 
Box and Blocks Test (BBT)30: is an assessment tool that measures the person's 
unimanual gross motor skills. It consists of carrying the maximum number of 
wooden blocks from one side of the box to the other for 1 minute. 
- 
Purdue Pegboard Test (PPT)31: is a test that aims to measure unimanual and 
bimanual finger dexterity, gross hand and arm movement in patients with 
upper limb impairments resulting from neurological and musculoskeletal 
conditions. It consists of a board with two parallel rows with 25 holes in which 
different metal pins, washers and tubes are placed, which are located in the 
upper part of the board in four cavities. It has four parts: the first assesses 
dexterity of the dominant hand, the second with the non-dominant hand, the 

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third assesses simultaneous bimanual coordination and the last measures 
alternating bimanual coordination by means of an assembly task. 
- 
Motor Activity Log-30 (MAL)32: consists of a 30-item questionnaire which 
subjectively assesses the amount of use and quality of use of the affected 
upper limb after a stroke during the performance of different tasks of daily 
living. The score for each item ranges from 0 (no use of the affected arm to 
perform the activity) to 5 (includes the affected hand as before the stroke). 
- 
Duruöz Index (ID)33, also called the Cochin Scale, contains 18 questions and 
is a self-administered scale that measures the difficulty in performing ADLs of 
cooking, dressing, personal hygiene, office tasks, etc. Patients rate their 
dexterity from 0 (no difficulty) to 5 (impossible to perform). 
- 
Functional Independence Scale (FIM)34: is an 18-item global measure of 
disability. Each item has seven ordinal levels of scores from 1 (total 
assistance) to 7 (total autonomy) in order to quantify the functional 
independence of the person assessed.  
- 
Visual Analogue Scale (EVA)35: this is a scale to assess the impact or current 
amount of pain the patient has. It is based on a 10-centimetre line with both 
ends clearly delimited, differentiating at one end the score 0 'no pain', and at 
the other end the score 10 'the greatest pain possible or that I have ever felt'. 
The patient has to mark exactly the point along this line. Once it has been 
marked, it is measured with a tape measure and the measurement obtained 
is the assigned pain score..  
 
Other variables to be collected in the study: 
Sociodemographic data: sex, date of birth, mother tongue, level of studies 
completed, type of home and cohabitation situation, presence of caregiver (if yes, it 
is also collected whether it is formal or informal care and the hours per week), 
previous and current job, degree of disability and/or recognised dependency. 
 
Clinical data: diagnosis, date of diagnosis, aetiology and location of the injury, time 
of evolution, dominance, most affected upper limb, pharmacological treatment, time 
of admission to the current rehabilitation unit, time of rehabilitation since the stroke, 
other diagnoses and the presence of sensory, motor, cognitive or behavioural 
sequelae. 
 
Health and lifestyle: height and weight, smoking, drug and/or alcohol consumption. 
 

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Data on the implementation of the HomeGRASP programme: completed programme, 
days on which the exercises were not carried out, time spent during the session 
correcting the activities, modifications made during the programme, notes suggested 
by the participants during the programme. 
 
Accelerometry: The GeneActiv accelerometer (GENEActiv, ActivInsights Ltd, 
Kimbolton, 
United 
Kingdom, 
https://activinsights.com/digital-health-
technologies/professional-wearables/geneactiv/) will be used in both the intervention 
and control groups to assess adherence to the rehabilitation program and the 
intensity of physical activity performed during the study. This device will be worn on 
the wrist of the affected limb and will continuously measure acceleration across three 
axes, providing data on the duration, frequency, and intensity of daily physical 
activity. Participants in both groups will wear the accelerometer for the 8-week 
intervention period, allowing for comparison not only of adherence to the 
HomeGRASP program in the experimental group, but also of overall physical activity 
in the control group. The data will be downloaded weekly during occupational therapy 
sessions and processed at the end of the data collection period using R packages 
specifically designed for this purpose, such as GGIR. 
 
Procedure: 
 
The clinical staff of the occupational therapy areas of the centres that will participate 
in the trial will receive an informative session about the project. These professionals 
will be in charge of inviting the users of the centre who meet the inclusion and 
exclusion criteria to participate in the study and will be in charge of explaining the 
project in detail and collecting the informed consent. 
 
When the patient is included in the study, he/she will be assessed by a blinded 
assessor from an external resource, with no prior or subsequent contact with the 
patient, only to carry out the pre- and post-intervention assessments. This evaluator 
will collect both the variables from the assessment tools and the rest of the study 
variables (socio-demographic, clinical and health and lifestyle data). Once assessed, 
a randomisation process will be carried out in which the patient will be assigned to 
the experimental group or the control group. 
 
Once assigned to one of the two groups, the intervention phase will begin. Both 
groups will carry out their intervention within 8 weeks. During this period both groups 
will continue their conventional occupational therapy treatment, generally between 

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2-3 sessions per week of 45 minutes each, at the rehabilitation centre based on: 
mobilisation of the neurological upper limb if necessary (maximum 10 minutes), task-
oriented training and training in ADLs. Depending on the assigned group, in addition 
to the conventional treatment, the experimental group will perform the HomeGRASP 
programme. The control group will only perform the conventional treatment. 
Bearing in mind that, after a brain injury, it is very common to experience pain in the 
shoulder of the more affected arm, this programme includes exercises specifically 
designed to address such issues. However, if the exercises are not performed 
correctly, there is a risk that shoulder pain may develop or worsen if already present. 
Since the programme is supervised weekly by an occupational therapist, the Visual 
Analogue Scale (VAS) will be used during each follow-up session to monitor pain 
levels and assess their impact on programme adherence. It is not uncommon for 
some discomfort to arise during the initial weeks, but with proper supervision and 
timely adjustments to the exercises, this pain typically resolves within a short period 
and becomes mild or disappears entirely. Additionally, participants often report a 
noticeable reduction in pain sensations upon completion of the programme. 
 
If during the follow-up of the patient, regardless of the week of the intervention, the 
patient reports shoulder pain during the performance of any movement or during any 
specific exercise, this will be modified in a way that the therapist considers more 
appropriate (e.g. fewer repetitions, less range of motion, less weight load...) in order 
to allow the person to perform the exercise without excessive pain (VAS =<6). Just 
as the modification of the activities can be changed weekly to add more difficulty to 
the exercise, if necessary, it can also be varied as often as necessary to adjust to the 
user's capacity for movement and correct execution. If, despite the modification of 
these exercises, the pain on the VAS scale is greater than 7 for two weeks in a row, 
the patient will be withdrawn from the study in order to avoid possible complications 
and/or increased pain. 
 
At the end of the eight weeks, a post-intervention re-evaluation will be carried out 
by the external evaluator and the results obtained will be analysed. 
Analysis Plan 
All analyses will be conducted using R software version 4.4.1 (R Foundation for 
Statistical Computing, Vienna, Austria; http://www.r-project.org). A two-sided 
significance level of 0.05 will be considered statistically significant. 
To assess the normality of continuous variables, the Kolmogorov-Smirnov test with 
Lilliefors correction will be applied. Quantitative variables will be described using 
means and standard deviations or medians and interquartile ranges, depending on 

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their distribution. Categorical variables will be reported as absolute and relative 
frequencies (n, %). 
To compare baseline sociodemographic, lifestyle, or clinical characteristics between 
intervention groups, the Student’s t-test or Mann-Whitney U test will be used for 
continuous variables with parametric or non-parametric distributions, respectively, 
and the chi-square test for categorical variables. 
To assess within-group changes before and after the intervention, paired Student’s t-
tests or Wilcoxon signed-rank tests will be applied depending on the normality of the 
data. Between-group comparisons of pre-post changes will be analysed using the 
independent Student’s t-test or Mann-Whitney U test, as appropriate. In all 
comparisons, effect sizes will be estimated using Cohen’s d for parametric data or 
Cliff’s delta as a non-parametric alternative, in order to quantify the magnitude of 
the observed differences. 
To evaluate changes in functionality and quality of life, as well as secondary 
outcomes, between intervention groups while adjusting for potential confounders, 
multiple linear regression models will be used. Baseline values of the outcome 
variables will be included as covariates to reduce regression to the mean. Confounder 
selection will be based on a thorough literature review. Variables with a p-value < 
0.20 in bivariate analysis and that modify the estimated effect by more than 10% 
after adjustment will be included in the final model. If missing data are found in 
confounding variables (<15%), multiple imputation methods will be considered. 
Data analysis will be conducted using both intention-to-treat (ITT) and per-protocol 
(PP) approaches. The ITT analysis will include all participants as originally allocated 
at randomisation, regardless of treatment adherence or completion. For ITT, linear 
mixed-effects models will be applied. This approach is especially relevant considering 
that some participants may drop out due to pain or other reasons, offering a realistic 
assessment of the intervention's impact in clinical practice. 
The per-protocol analysis will include only those participants who strictly followed the 
study protocol. This analysis will exclude participants who withdrew, did not adhere 
to the treatment, or switched groups, providing an estimate of the treatment effect 
under optimal adherence conditions.