Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07146789

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

Led by Universidad Miguel Hernandez de Elche · Updated on 2025-08-28

70

Participants Needed

1

Research Sites

99 weeks

Total Duration

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Sponsors

U

Universidad Miguel Hernandez de Elche

Lead Sponsor

H

Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or have help from a caregiver.
  • Perform at least 10 degrees of active wrist or finger extension.
  • Ability to raise the scapula of the affected upper limb against gravity.
Not Eligible

You will not qualify if you...

  • Having neurological conditions other than stroke.
  • Experiencing excessive pain in the affected upper limb that prevents correctly performing exercises (Visual Analogue Scale > 7).
  • Having a visual perception deficit preventing correct exercise performance.
  • Excessive muscle tone (spasticity or hypertonia) preventing correct exercise performance (Ashworth > 2).
  • A Folstein Mini-Mental State Examination (MMSE) score of 22 or less.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen

Valencia, Spain, 46011

Actively Recruiting

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Research Team

E

Eva María Navarrete Muñoz, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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