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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate

Timeframe: 45 days (post-intervention)

Retention rate

Timeframe: 45 days (post-intervention)

Adherence to the intervention protocol

Timeframe: 45 days (post-intervention)

Safety

Timeframe: 45 days (post-intervention)

Activity ratio

Timeframe: Day 1 (enrolment)

Activity ratio

Timeframe: Day 17 (baseline)

Activity ratio

Timeframe: 45 days (post-intervention)

Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

Timeframe: Day 1 (enrolment)

Trial details

NCT IDNCT05227521

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-25

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recruitment rate

Timeframe: 45 days (post-intervention)

Retention rate

Timeframe: 45 days (post-intervention)

Adherence to the intervention protocol

Timeframe: 45 days (post-intervention)

Safety

Timeframe: 45 days (post-intervention)

Activity ratio

Timeframe: Day 1 (enrolment)

Activity ratio

Timeframe: Day 17 (baseline)

Activity ratio

Timeframe: 45 days (post-intervention)

Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand)

Timeframe: Day 1 (enrolment)