NCT07146789 Home-based Graded Repetitive Arm Supplementary Program for Quality of Life and Functional Upper Limb Recovery
| NCT ID | NCT07146789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Miguel Hernandez de Elche |
| Condition | Stroke With Hemiparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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.
Contact & Investigator
Carlos Soler Pons, Occupational Therapy
STUDY DIRECTOR
Fundación Hospitalarias Valencia
Frequently Asked Questions
Who can join the NCT07146789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke With Hemiparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07146789 currently recruiting?
Yes, NCT07146789 is actively recruiting participants. Contact the research team at enavarrete@umh.es for enrollment information.
Where is the NCT07146789 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT07146789 clinical trial?
NCT07146789 is sponsored by Universidad Miguel Hernandez de Elche. The principal investigator is Carlos Soler Pons, Occupational Therapy at Fundación Hospitalarias Valencia. The trial plans to enroll 70 participants.
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