Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- KU Leuven
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Correlation between Ad-AHA Stroke total score and accelerometer-derived Use Ratio
Study Overview
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.
Detailed Description
This is a single-center, cross-sectional observational study designed to examine the relationship between Ad-AHA Stroke scores and real-life bimanual hand use derived from accelerometry data in chronic stroke survivors.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≤
- •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).
Outcomes
Primary Outcomes
Correlation between Ad-AHA Stroke total score and accelerometer-derived Use Ratio
Time Frame: Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period
The primary endpoint is the strength of association between the Ad-AHA Stroke total score, obtained during the measurement visit, and real-world bimanual upper limb use, quantified by the accelerometer-derived Use Ratio calculated from the subsequent 3-day home monitoring period. The Use Ratio is calculated as the total duration of activity of the affected limb divided by that of the non-affected limb (range 0-1, with 1 indicating equal use of both limbs). This measure reflects spontaneous bimanual activity balance and serves as the primary indicator of the ecological validity of the Ad-AHA Stroke.
Secondary Outcomes
- Correlation between Ad-AHA Stroke score and composite accelerometer index(Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period)
Investigators
Prof Geert Verheyden
Professor of Rehabilitation Sciences
KU Leuven