Home GRASP program to improve arm function and quality of life after stroke
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
This trial will try adding a home-based GRASP exercise program to usual occupational therapy to see if people 3 to 12 months after a single stroke with hemiparesis regain more arm function and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Miguel Hernandez de Elche Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT07146789 on ClinicalTrials.gov |
What this trial studies
The trial randomizes adults to usual occupational therapy versus usual therapy plus the Spanish HomeGRASP program, a graded, repetitive arm exercise regimen delivered at home with weekly occupational therapist supervision. The HomeGRASP intervention is designed to increase upper-limb rehabilitation time by up to seven additional hours per week through structured practice grounded in motor learning. Eligible participants are adults 3–12 months after a single stroke with some active wrist or finger extension and the ability to follow instructions or receive caregiver assistance. Main outcomes include measures of upper-limb function, autonomy in activities of daily living, and quality of life assessed after the intervention period.
Who should consider this trial
Good fit: Adults 18 years or older, 3 to 12 months after a single stroke with hemiparesis who can perform minimal wrist/finger extension or have caregiver support and can attend visits in the Valencia area.
Not a fit: People with other neurological disorders, severe shoulder pain that prevents exercise, major visual-perceptual deficits, or who cannot perform the exercises even with help are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could help stroke survivors regain more arm function and greater independence by increasing accessible rehabilitation time at home.
How similar studies have performed: Prior studies of GRASP and similar graded home exercise programs have shown improved upper-limb outcomes, although the Spanish HomeGRASP implementation in this setting is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Valencia
- Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Eva María Navarrete Muñoz, Phd — Universidad Miguel Hernández de Elche
- Study coordinator: Eva María Navarrete Muñoz, Phd
- Email: enavarrete@umh.es
- Phone: +34686587209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.