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

NCT ID: NCT07146789

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-02-28

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).

Detailed Description

Stroke is a sudden neurological event that can cause temporary or permanent impairments depending on the brain area affected. Among the resulting deficits, the loss of upper limb functionality on the affected side is one of the greatest challenges in rehabilitation. It is estimated that at least 80% of stroke survivors experience some degree of upper limb dysfunction, while only about 15% achieve significant functional recovery. Given the critical role of the arms and hands in performing activities of daily living (ADLs), such impairments can severely reduce a person's independence and contribute to long-term disability.

Recent studies have highlighted that the time allocated for upper limb rehabilitation in standard care is often insufficient. Increasing the intensity of therapy has been shown to yield better functional outcomes, especially in the chronic phase of stroke recovery. Strategies to increase intensity include extending the duration of therapy sessions and promoting a higher number of task repetitions, which support motor learning and functional generalisation. While technologies such as robotics and virtual reality are being used to deliver more intensive therapy at home, they often come with increased costs and usability barriers, particularly for older adults or those unfamiliar with digital tools.

A practical solution is the implementation of structured home-based exercise programmes. One such programme is the Graded Repetitive Arm Supplementary Program (GRASP), developed by the University of British Columbia. GRASP consists of a set of 33 structured exercises targeting various aspects of upper limb rehabilitation, including stretching, strength, coordination, and fine motor skills. It is delivered in a self-directed format with weekly supervision by an occupational therapist. The programme includes initial in-person instruction, delivery of all required materials, and weekly monitoring through exercise logs and patient feedback. Pain levels are tracked using a visual analogue scale to ensure patient safety and guide therapy adjustments. The standard application involves performing one hour of daily exercises, seven days a week, over an eight-week period.

Conditions

Stroke With Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

occupational therapy combined with HomeGRASP program

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

occupational therapy

Intervention Type: 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.

Interventions

occupational therapy combined with HomeGRASP program

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.

Intervention Type: OTHER

occupational therapy

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain

UNKNOWN

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

Eva María Navarrete Muñoz

Doctora por la Universidad Miguel Hernandez de Elche

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Soler Pons, Occupational Therapy

Role: STUDY_DIRECTOR

Fundación Hospitalarias Valencia

Eva María Navarrete Muñoz, Phd

Role: PRINCIPAL_INVESTIGATOR

Universidad Miguel Hernández de Elche

Desirée Valera Gran, Phd

Role: PRINCIPAL_INVESTIGATOR

Universidad Miguel Hernández de Elche

Locations

Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Eva María Navarrete Muñoz, Phd

Role: CONTACT

enavarrete@umh.es

+34686587209

Facility Contacts

Carlos Soler Pons, Occupational Therapist

Role: primary

carlossolerpons@gmail.com

+34608082941

References

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.

Reference Type: BACKGROUND

PMID: 33682872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27017890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24505098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25112430 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19359633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38329448 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://neurorehab.med.ubc.ca/grasp/

Web page about original GRASP program

Other Identifiers

240408194759

Identifier Type: -

Identifier Source: org_study_id