Feasibility of the Adapted H-GRASP Feedback Program in the Chronic Phase Post Stroke. (NCT05227521) | Clinical Trial Compass
CompletedPhase 1/2
Feasibility of the Adapted H-GRASP Feedback Program in the Chronic Phase Post Stroke.
Belgium19 participantsStarted 2022-01-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Recruitment rate
Timeframe: 45 days (post-intervention)
2
Retention rate
Timeframe: 45 days (post-intervention)
3
Adherence to the intervention protocol
Timeframe: 45 days (post-intervention)
4
Safety
Timeframe: 45 days (post-intervention)
5
Activity ratio
Timeframe: Day 1 (enrolment)
6
Activity ratio
Timeframe: Day 17 (baseline)
7
Activity ratio
Timeframe: 45 days (post-intervention)
8
Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)
Timeframe: Day 1 (enrolment)
9
Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)