See if the Ad-AHA Stroke test reflects real-life two-handed hand use after stroke.
Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures
We will test whether the Ad-AHA Stroke test reflects how adults with chronic stroke use both hands in everyday life by comparing test scores to three days of wrist-worn sensor data.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT07366697 on ClinicalTrials.gov |
What this trial studies
This single-center, cross-sectional study at KU Leuven will compare scores on the Adult Assisting Hand Assessment - Stroke version (Ad-AHA Stroke) with real-world bimanual hand-use measured by bilateral wrist-worn accelerometers over three consecutive days. Eligible participants are community-dwelling adults 18–80 years old at least six months after a unilateral supratentorial stroke, with observable bimanual impairment but not severe upper-limb paralysis. Clinical assessment and the Ad-AHA Stroke will be performed at the clinic, and sensor data will capture day-to-day arm use in participants' home environments. The goal is to determine whether the Ad-AHA Stroke score corresponds to actual everyday bimanual performance recorded by sensors.
Who should consider this trial
Good fit: Adults aged 18–80, at least six months after a unilateral supratentorial stroke, living at home, with observable bimanual impairment and able to wear bilateral wrist sensors for three days are ideal candidates.
Not a fit: People with severe upper-limb impairment (FMA-UE ≤ 15), major cognitive or language barriers to following instructions, or other neurological/orthopedic conditions affecting the arms are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could give clinicians a more accurate picture of how people use both hands in daily life and help tailor rehabilitation to real-world needs.
How similar studies have performed: Previous studies have used wrist accelerometers to quantify arm use after stroke and shown correlations with some clinical measures, but directly validating the Ad-AHA Stroke against multi-day real-world sensor data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Leuven
- Department of Rehabilitation Sciences, KU Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Geert Verheyden — KU Leuven
- Study coordinator: Geert Verheyden, PhD
- Email: geert.verheyden@kuleuven.be
- Phone: +32 16 32 91 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.