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

NCT07146789 | Recruiting DMC

• 1 other identifier: 240408194759
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke With Hemiparesis

Keywords

stroke; hemiparesis; upper limb; upper extremity; recovery

Outcome Measures

Primary Outcomes (2)

• Functionality of the affected upper limb through tasks

  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.

  2 month

• Quality of life as perceived by the patient

  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.

  2 months

Secondary Outcomes (5)

• Assess the gross motor skills of the patient's affected upper limb

  2 months

• Assessing the fine motor skills of the patient's affected upper limb

  2 months

• To assess the real use of the affected upper limb in activities of daily living.

  2 months

• Assessing the difficulty patients have when carrying out daily activities with their hands.

  2 months

• Valuing the independence of the patient in activities of daily living.

  2 months

Study Arms (2)

HomeGRASP and occupational therapy

EXPERIMENTAL

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.

Other: occupational therapy combined with HomeGRASP program

Grupo control

ACTIVE COMPARATOR

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.

Other: occupational therapy

Interventions

occupational therapy combined with HomeGRASP program OTHER

To the present date there has been no trial combining conventional treatment with the GRASP programme as opposed to conventional treatment alone. Therefore, it is necessary to translate and adapt the materials transculturally so that it can be applied in Spain and verify the changes that occur in perceived quality of life and functionality of the affected upper limb as primary outcomes, as well as evaluating manipulative skills, use of the upper limb in ADLs and personal autonomy as secondary outcomes. All this, through the HomeGRASP programme as a complement to conventional rehabilitation in occupational therapy.

HomeGRASP and occupational therapy

occupational therapy OTHER

It will consist solely of 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 you attend. The approaches to 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.

Grupo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain: collaborator

Study Sites (1)

Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen

Valencia, 46011, Spain

RECRUITING

Related Publications (6)

• Yang CL, Waterson S, Eng JJ. Implementation and Evaluation of the Virtual Graded Repetitive Arm Supplementary Program (GRASP) for Individuals With Stroke During the COVID-19 Pandemic and Beyond. Phys Ther. 2021 Jun 1;101(6):pzab083. doi: 10.1093/ptj/pzab083.

  PMID: 33682872 BACKGROUND

• Simpson LA, Eng JJ, Chan M. H-GRASP: the feasibility of an upper limb home exercise program monitored by phone for individuals post stroke. Disabil Rehabil. 2017 May;39(9):874-882. doi: 10.3109/09638288.2016.1162853. Epub 2016 Mar 26.

  PMID: 27017890 BACKGROUND

• Connell LA, McMahon NE, Watkins CL, Eng JJ. Therapists' use of the Graded Repetitive Arm Supplementary Program (GRASP) intervention: a practice implementation survey study. Phys Ther. 2014 May;94(5):632-43. doi: 10.2522/ptj.20130240. Epub 2014 Feb 6.

  PMID: 24505098 BACKGROUND

• Connell LA, McMahon NE, Harris JE, Watkins CL, Eng JJ. A formative evaluation of the implementation of an upper limb stroke rehabilitation intervention in clinical practice: a qualitative interview study. Implement Sci. 2014 Aug 12;9:90. doi: 10.1186/s13012-014-0090-3.

  PMID: 25112430 BACKGROUND

• Harris JE, Eng JJ, Miller WC, Dawson AS. A self-administered Graded Repetitive Arm Supplementary Program (GRASP) improves arm function during inpatient stroke rehabilitation: a multi-site randomized controlled trial. Stroke. 2009 Jun;40(6):2123-8. doi: 10.1161/STROKEAHA.108.544585. Epub 2009 Apr 9.

  PMID: 19359633 BACKGROUND

• Essers B, Veerbeek JM, Luft AR, Verheyden G. The feasibility of the adapted H-GRASP program for perceived and actual daily-life upper limb activity in the chronic phase post-stroke. Disabil Rehabil. 2024 Dec;46(24):5815-5828. doi: 10.1080/09638288.2024.2313121. Epub 2024 Feb 8.

  PMID: 38329448 BACKGROUND

Related Links

• Web page about original GRASP program

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Carlos Soler Pons, Occupational Therapy

  Fundación Hospitalarias Valencia

  STUDY DIRECTOR

• Eva María Navarrete Muñoz, Phd

  Universidad Miguel Hernández de Elche

  PRINCIPAL INVESTIGATOR

• Desirée Valera Gran, Phd

  Universidad Miguel Hernández de Elche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva María Navarrete Muñoz, Phd

CONTACT

+34686587209; enavarrete@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator will carry out the statistical analysis without any contact with the participants or involvement in data collection. All participant assessments will be conducted by an external evaluator who is not involved in the implementation of the intervention or the project team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctora por la Universidad Miguel Hernandez de Elche

Model Details: This is a single-blind, two-arm, parallel-group, randomised controlled trial to evaluate the effectiveness of the Spanish version of the HomeGRASP programme as an adjunct to conventional occupational therapy in adults post-stroke. Participants will be randomly assigned to: (1) Control group: conventional occupational therapy (2-3 sessions/week, 45 minutes each) including task-oriented training, ADL training, and mobilisation if needed (max. 10 min); or (2) Intervention group: the same conventional therapy plus the HomeGRASP programme (1 hour/day, 7 days/week for 8 weeks), supervised weekly by an occupational therapist, who reviews and adjusts the exercise plan during the session. Assessments will be performed at baseline and post-intervention by a blinded evaluator.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 28, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)