NCT07366697 Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures
| NCT ID | NCT07366697 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 32 participants in total. It began in 2025-12-10 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
After a stroke, many people experience difficulty using both hands together in daily life. Most rehabilitation assessments, however, only measure how the affected arm performs in one-handed tasks. This makes it difficult to understand how well people actually use their hands in real-world activities, which are usually bimanual. The Adult Assisting Hand Assessment - Stroke version (Ad-AHA Stroke) is a new clinical test that evaluates how the affected hand performs during two-handed tasks. While promising, it is still unknown whether the score on this test truly reflects how stroke survivors use their hands in daily life. This study aims to investigate this question by comparing Ad-AHA Stroke scores with real-life data on hand use, recorded over three days using wrist-worn sensors on both arms. By combining clinical and sensor-based measures, this study will help determine whether the Ad-AHA Stroke can accurately represent everyday bimanual performance after stroke.
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained prior to any study procedures. * Age between 18 and 80 years (inclusive). * Unilateral supratentorial stroke involving cortical or subcortical structures. * At least 6 months post-stroke at the time of inclusion. * Community-dwelling (discharged from hospital and currently living at home). * Able and willing to wear bilateral wrist-worn sensors (triaxial accelerometers) for three consecutive days. * Presence of clinically observable bimanual impairment. Exclusion Criteria: * Severe upper limb impairment, defined as a Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score ≤ 15. * Severe cognitive or language comprehension impairment interfering with understanding of study instructions or task performance, as judged during screening. * Presence of other neurological or orthopedic conditions affecting upper limb function (e.g., Parkinson's disease, multiple sclerosis, severe osteoarthritis, brachial plexus injury).
Contact & Investigator
Geert Verheyden
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT07366697 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07366697 currently recruiting?
Yes, NCT07366697 is actively recruiting participants. Contact the research team at geert.verheyden@kuleuven.be for enrollment information.
Where is the NCT07366697 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07366697 clinical trial?
NCT07366697 is sponsored by KU Leuven. The principal investigator is Geert Verheyden at KU Leuven. The trial plans to enroll 32 participants.
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