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

Official title

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

Overview

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.

Interventions

• Other 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 ou
• 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.

Primary outcome measures

• Functionality of the affected upper limb through tasks [Time frame: 2 month]
• Quality of life as perceived by the patient [Time frame: 2 months]

Secondary outcome measures (5)

• Assess the gross motor skills of the patient's affected upper limb [Time frame: 2 months]
• Assessing the fine motor skills of the patient's affected upper limb [Time frame: 2 months]
• To assess the real use of the affected upper limb in activities of daily living. [Time frame: 2 months]
• Assessing the difficulty patients have when carrying out daily activities with their hands. [Time frame: 2 months]
• Valuing the independence of the patient in activities of daily living. [Time frame: 2 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Fundación Hopitalarias, Centro sociosanitario Nuestra señora del Carmen — Valencia

Publications

• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07146789 · 240408194759

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗