About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
occupational therapy combined with HomeGRASP program
Other interventionTo 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.
occupational therapy
Other interventionIt 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Assess the gross motor skills of the patient's affected upper limb
Box and Blocks Test (BBT): this is an assessment tool that measures a person's gross unimanual motor skills. It consists of moving the maximum number of wooden blocks from one side of the box to the other in one minute.
Assessing the fine motor skills of the patient's affected upper limb
Purdue Pegboard Test (PPT): this test aims to measure the unimanual and bimanual dexterity of the fingers, the gross movement of the hands and arms in patients with upper limb deficiencies as a result of neurological and musculoskeletal conditions. It consists of a board with two parallel rows with 25 holes in which different metal pegs, washers and tubes are placed, which are located in the upper part of the board in four cavities. It has four parts: the first assesses the dexterity of the dominant hand, the second the non-dominant hand, the third evaluates simultaneous bimanual coordination and the last measures alternating bimanual coordination through an assembly task.
To assess the real use of the affected upper limb in activities of daily living.
Motor Activity Log-30 (MAL): this consists of a questionnaire with 30 items in which the amount and quality of use of the upper limb affected after a stroke is subjectively assessed when carrying out different tasks of daily living. The score for each item varies between 0 (does not use the affected arm to carry out the activity) and 5 (includes the affected hand in the same way as before the stroke).
Assessing the difficulty patients have when carrying out daily activities with their hands.
The Duruöz Index (DI), also called the Cochin Scale, contains 18 questions and is a self-administered scale that measures the difficulty of performing ADLs such as cooking, dressing, personal hygiene, office tasks, etc. Patients rate their ability from 0 (no difficulty) to 5 (impossible to perform).
Sponsors and contacts
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Universidad Miguel Hernandez de Elche
Lead sponsor
Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain
Collaborator