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NCT07366697Recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
32 (estimated)
First submitted
8 Jan 2026
Start date
10 Dec 2025
Primary completion date
Jun 2028
Lead sponsor
KU Leuven
Diseases
Stroke
NCT number
NCT07366697

What you commit to

  • Study type: Observational
  • Planned participants: 32
  • From 10 Dec 2025 to the primary completion date, Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Rehabilitation Sciences KU Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.