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

Not Applicable

Recruiting

• Conditions: Stroke With Hemiparesis

• Registration Number: NCT07146789
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief Summary

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).

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 Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2026-12-30
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functionality of the affected upper limb through tasks	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.
Quality of life as perceived by the patient	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.

Secondary Outcome Measures

Name	Time	Method
Assess the gross motor skills of the patient's affected upper limb	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.
Assessing the fine motor skills of the patient's affected upper limb	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.
To assess the real use of the affected upper limb in activities of daily living.	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).
Assessing the difficulty patients have when carrying out daily activities with their hands.	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).
Valuing the independence of the patient in activities of daily living.	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.

Trial Locations

Locations (1)

Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen; 🇪🇸 Valencia, Spain