Home-based Graded Repetitive Arm Supplementary Program for Quality of Life and Functional Upper Limb Recovery (REC-HOMEGRASP)

August 25, 2025 updated by: Eva María Navarrete Muñoz, Universidad Miguel Hernandez de Elche

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

In post-stroke rehabilitation of the affected upper limb, increasing treatment intensity has been shown to lead to better outcomes compared to conventional approaches with fewer hours of therapy per day and week. However, logistical, human, and material constraints in neurorehabilitation centres often limit the feasibility of increasing treatment intensity.

The GRASP programme (Graded Repetitive Arm Supplementary Program) is a home-based exercise intervention grounded in motor learning principles and conducted weekly under the supervision of an occupational therapist. This strategy enables the intensity of upper limb rehabilitation to be increased by up to seven additional hours per week.

This project aims to evaluate the effectiveness of the Spanish version of the HomeGRASP programme, implemented as an adjunct to conventional occupational therapy, in improving quality of life, autonomy, and upper limb functionality in people after stroke. To this end, a single-blind, randomised controlled clinical trial will be conducted. Participants in the experimental group will receive conventional occupational therapy in addition to the HomeGRASP programme performed at home, while those in the control group will receive only conventional therapy. The treatment period for both groups will last eight weeks.

Participants will be assessed at baseline and after the 8-week intervention period by a blinded evaluator. The primary outcomes will include changes in quality of life and upper limb functionality, measured using the CAVIDACE scale and the Wolf Motor Function Test. Secondary outcomes will include upper limb dexterity and personal autonomy, assessed using the Box and Block Test, Purdue Pegboard Test, Motor Activity Log-30, Duruöz Hand Index, and the Functional Independence Measure (FIM).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is a sudden neurological event that can cause temporary or permanent impairments depending on the brain area affected. Among the resulting deficits, the loss of upper limb functionality on the affected side is one of the greatest challenges in rehabilitation. It is estimated that at least 80% of stroke survivors experience some degree of upper limb dysfunction, while only about 15% achieve significant functional recovery. Given the critical role of the arms and hands in performing activities of daily living (ADLs), such impairments can severely reduce a person's independence and contribute to long-term disability.

Recent studies have highlighted that the time allocated for upper limb rehabilitation in standard care is often insufficient. Increasing the intensity of therapy has been shown to yield better functional outcomes, especially in the chronic phase of stroke recovery. Strategies to increase intensity include extending the duration of therapy sessions and promoting a higher number of task repetitions, which support motor learning and functional generalisation. While technologies such as robotics and virtual reality are being used to deliver more intensive therapy at home, they often come with increased costs and usability barriers, particularly for older adults or those unfamiliar with digital tools.

A practical solution is the implementation of structured home-based exercise programmes. One such programme is the Graded Repetitive Arm Supplementary Program (GRASP), developed by the University of British Columbia. GRASP consists of a set of 33 structured exercises targeting various aspects of upper limb rehabilitation, including stretching, strength, coordination, and fine motor skills. It is delivered in a self-directed format with weekly supervision by an occupational therapist. The programme includes initial in-person instruction, delivery of all required materials, and weekly monitoring through exercise logs and patient feedback. Pain levels are tracked using a visual analogue scale to ensure patient safety and guide therapy adjustments. The standard application involves performing one hour of daily exercises, seven days a week, over an eight-week period.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eva María Navarrete Muñoz, Phd
  • Phone Number: +34686587209
  • Email: enavarrete@umh.es

Study Locations

  • Spain
      • Valencia, Spain, 46011
        • Recruiting
        • Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen
        • Contact:
        • Sub-Investigator:
          • Nayara Sánchez García, Occupational therapy
        • Sub-Investigator:
          • Pablo García Millán, Occupational therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be of legal age.
  • Have suffered only one stroke and be clinically stable.
  • At least 3 months must have passed since the stroke and less than 12 months.
  • Signing of informed consent
  • Be able to communicate any adverse effects (e.g. shoulder pain)
  • Be able to follow instructions and perform the exercises independently for one hour. If they are not able to do so, have the help of a caregiver to ensure that the exercises are performed.
  • Perform at least 10º of active wrist or finger extension.
  • Ability to raise the scapula of the affected upper limb against gravity.

Exclusion Criteria:

  • Having neurological conditions other than stroke.
  • Experiencing excessive pain in the affected upper limb that prevents the patient from correctly performing the exercises proposed in the programme. Visual Analogue Scale (VAS > 7).
  • Having a visual perception deficit that prevents the patient from correctly performing the exercises proposed in the programme.
  • Excessive muscle tone (spasticity or hypertonia) that prevents the person from correctly performing the exercises proposed in the programme. Asworth > 2.
  • A Folstein Mini-Mental State Examination (MMSE) score of ≥22 is required.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HomeGRASP and occupational therapy
The experimental group will carry out the conventional treatment described in the control group together with the HomeGRASP programme at home. This programme consists of one hour of exercises at home, seven days a week, for a period of eight weeks. As the programme involves supervision by the occupational therapist of the exercises carried out at home, 20-30 minutes of the conventional session will be devoted to reviewing this plan. Before the programme starts, an explanatory session will be held with the patient and, if necessary, with the carer to show and teach the correct way to do the exercises proposed in the programme, as well as providing the material needed to do them.
Other: occupational therapy combined with HomeGRASP program
To the present date there has been no trial combining conventional treatment with the GRASP programme as opposed to conventional treatment alone. Therefore, it is necessary to translate and adapt the materials transculturally so that it can be applied in Spain and verify the changes that occur in perceived quality of life and functionality of the affected upper limb as primary outcomes, as well as evaluating manipulative skills, use of the upper limb in ADLs and personal autonomy as secondary outcomes. All this, through the HomeGRASP programme as a complement to conventional rehabilitation in occupational therapy.
Active Comparator: Grupo control
The control group will only receive conventional occupational therapy treatment at the rehabilitation centre. The conventional treatment sessions will be based on: generally between 2-3 sessions a week lasting 45 minutes each at the rehabilitation centre they attend. The approaches that will be used during the sessions will be based solely on mobilisations of the affected upper limb if necessary (maximum 10 minutes of the session), task-oriented training and training in ADLs.
Other: occupational therapy
It will consist solely of conventional occupational therapy treatment at the rehabilitation centre. The conventional treatment sessions will be based on: generally between 2-3 sessions a week lasting 45 minutes each at the rehabilitation centre you attend. The approaches to be used during the sessions will be based solely on mobilisations of the affected upper limb if necessary (maximum 10 minutes of the session), task-oriented training and training in ADLs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality of the affected upper limb through tasks
Time Frame: 2 month
Wolf Motor Function Test (WMFT): quantifies the motor capacity of the upper limbs (UL) through timed and functional tasks. The tool consists of 17 elements including 6 items involving 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.
2 month
Quality of life as perceived by the patient
Time Frame: 2 months
CAVIDACE: this is an evaluation of the perceived quality of life of adults with brain damage from the perspective of an external evaluator. It is recorded by a person who knows the user well (e.g. professionals, family members, 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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the gross motor skills of the patient's affected upper limb
Time Frame: 2 months
Box and Blocks Test (BBT): this is an assessment tool that measures a person's gross unimanual motor skills. It consists of moving the maximum number of wooden blocks from one side of the box to the other in one minute.
2 months
Assessing the fine motor skills of the patient's affected upper limb
Time Frame: 2 months
Purdue Pegboard Test (PPT): this test aims to measure the unimanual and bimanual dexterity of the fingers, the gross movement of the hands and arms in patients with upper limb deficiencies as a result of neurological and musculoskeletal conditions. It consists of a board with two parallel rows with 25 holes in which different metal pegs, 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 the dexterity of the dominant hand, the second the non-dominant hand, the third evaluates simultaneous bimanual coordination and the last measures alternating bimanual coordination through an assembly task.
2 months
To assess the real use of the affected upper limb in activities of daily living.
Time Frame: 2 months
Motor Activity Log-30 (MAL): this consists of a questionnaire with 30 items in which the amount and quality of use of the upper limb affected after a stroke is subjectively assessed when carrying out different tasks of daily living. The score for each item varies between 0 (does not use the affected arm to carry out the activity) and 5 (includes the affected hand in the same way as before the stroke).
2 months
Assessing the difficulty patients have when carrying out daily activities with their hands.
Time Frame: 2 months
The Duruöz Index (DI), also called the Cochin Scale, contains 18 questions and is a self-administered scale that measures the difficulty of performing ADLs such as cooking, dressing, personal hygiene, office tasks, etc. Patients rate their ability from 0 (no difficulty) to 5 (impossible to perform).
2 months
Valuing the independence of the patient in activities of daily living.
Time Frame: 2 months
Functional Independence Measure (FIM): this is an 18-item global measure of disability. Each item has seven ordinal levels of scoring from 1 (total care) to 7 (total independence) in order to quantify the functional independence of the person being evaluated.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain

Investigators

  • Study Director: Carlos Soler Pons, Occupational Therapy, Fundación Hospitalarias Valencia
  • Principal Investigator: Eva María Navarrete Muñoz, Phd, Universidad Miguel Hernandez de Elche
  • Principal Investigator: Desirée Valera Gran, Phd, Universidad Miguel Hernandez de Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

July 31, 2025

First Submitted That Met QC Criteria

August 25, 2025

First Posted (Estimated)

August 28, 2025

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240408194759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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