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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen
RECRUITING
Valencia
Contact Information
Primary
Eva María Navarrete Muñoz, Phd
enavarrete@umh.es
+34686587209
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 70
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain
Leads: Universidad Miguel Hernandez de Elche

This content was sourced from clinicaltrials.gov