Feasibility of the Adapted H-GRASP Feedback Program in the Chronic Phase Post Stroke.

Study Overview
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Brief Summary
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In a recent cross-sectional study, it was shown that people with a good observed upper limb (UL) motor function but low perceived UL activity show a reduced daily-life UL activity. The investigators will now investigate the feasibility of a phone-monitored home exercise and feedback program for the UL following stroke and the preliminary effects on the perceived UL activity and actual daily-life UL activity for participants with good observed UL motor function but low perceived UL activity in the chronic phase post-stroke.

Official Title
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The Feasibility of the Adapted H-GRASP Feedback Program for Perceived and Daily Life UL Activity in Patients With Good Observed But Low Perceived Activity in the Chronic Phase Post Stroke: a Pilot Study.

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Adapted H-GRASP feedback program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary written informed consent of the participant has been obtained prior to any screening procedures First-ever unilateral, supratentorial stroke, as defined by the American Heart Association/American Stroke Association Minimum six months after stroke Living in the community ≥18 years old Good observed UL motor function but low perceived UL activity. Good observed UL motor function is defined as a score >50/66 on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Low perceived UL activity is defined as a score ≤75/100 on the hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand). Exclusion Criteria: Other neurological condition than stroke Musculoskeletal disorder that affects UL use No informed consent Participation in an interventional Study with an investigational medicinal product (IMP) or device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AH-GRASP feedback intervention group<br>All study participants will receive the AH-GRASP feedback intervention. | Behavioral: Adapted H-GRASP feedback program<br>* Combination of the Home-Graded Repetitive Arm Supplementary Program with in home accelerometer-based feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | % of individuals who were eligible and agreed to participate | 45 days (post-intervention) | 
| Retention rate | % of participants who completed the intervention | 45 days (post-intervention) | 
| Adherence to the intervention protocol | % of participants who achieved 12 hours of average weekly exercise | 45 days (post-intervention) | 
| Safety | # of participants with increased pain while performing exercises as measured by visual analogue scale | 45 days (post-intervention) | 
| Activity ratio | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL | Day 1 (enrolment) | 
| Activity ratio | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL | Day 17 (baseline) | 
| Activity ratio | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL | 45 days (post-intervention) | 
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) | Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | Day 1 (enrolment) | 
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) | Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | Day 17 (baseline) | 
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) | Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | 45 days (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer motor assessment - upper extremity (FMA-UE) | Observed motor function of the affected UL (shoulder, arm, wrist, hand, and fingers) | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | 
| Action Research Arm Test (ARAT) | Grasp, grip, pinch and gross movement of the affected UL | Day 17 (baseline), 45 days (post-intervention) | 
| Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU) | Patient-reported amount of UL use in daily life | Day 17 (baseline), 45 days (post-intervention) | 
| Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM) | Patient-reported quality of UL use in daily life | Day 17 (baseline), 45 days (post-intervention) | 
| Erasmus modified Nottingham Sensory Assessment (Em-NSA) | Sensory assessment of the UL | Day 17 (baseline), 45 days (post-intervention) | 
| simplified modified Rankin Scale questionnaire (smRSq) | Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome. | Day 17 (baseline), 45 days (post-intervention) | 
| Hospital Anxiety and Depression Scale (HADS) | Symptoms of anxiety and depression. Minimum 0 - maximum 42; higher scores mean worse outcome. | Day 17 (baseline), 45 days (post-intervention) | 
| Confidence in Arm and Hand Movement Scale (CAHM) | Perceived self-efficacy in performing tasks with the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | Day 17 (baseline), 45 days (post-intervention) | 
| Visual Analogue Scale (VAS) | Pain intensity in the affected UL from 0 (no pain) to 10 (extreme). Minimum 0, maximum 10, higher scores mean worse outcome. | Day 17 (baseline), 45 days (post-intervention) | 
| EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L) | Health-related quality of life. Minimum 0, maximum 100, higher scores mean better outcome. | Day 17 (baseline), 45 days (post-intervention) | 
| Hours of UL activity | Sum of all seconds recorded when the activity count was nonzero and converted to hours | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | 
| Bilateral magnitude | Intensity of the movement: sum of the vector magnitude from the two ULs | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | 
| Magnitude ratio | Contribution to the activity of one limb versus the other: natural log of the vector magnitude of the affected UL divided by the vector magnitude of the unaffected UL, whereby values greater than and less than -7 were replaced by 7 and -7, respectively, to categorize single limb movement. | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | 
| Density plot | Graphical representation of accelerometry data from both ULs | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper limb, daily life activity, home-based exercise program, feedback, perceived activity