Clinical trial Recruiting at 1 site Observational Ages 18 to 80

See if the Ad-AHA Stroke test reflects real-life two-handed hand use after stroke.

Official title: Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures

Run by KU Leuven · NCT07366697 · Data updated 2026-11-12

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.

More Stroke trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment32 (estimated)
SponsorKU Leuven
Academic / other
Locations1 site (Leuven)
StatusRecruiting
StartedDecember 10, 2025
Main results expectedJune 2028
Study endsJuly 2028
Registry record updatedOctober 21, 2026
Trial IDNCT07366697 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Department of Rehabilitation Sciences, KU Leuven
    Leuven, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.