Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sensor-based monitoring and clinical assessment.
- Who it may be relevant to
- Registry conditions: Stroke, Upper Limb Motor Impairment, Bimanual Function. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Sensor-based monitoring and clinical assessment
Participants will complete the Ad-AHA Stroke assessment and wear bilateral wrist accelerometers for 3 days to measure real-life bimanual activity. No treatment or experimental intervention will be administered.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Correlation between Ad-AHA Stroke score and composite accelerometer index [Time frame: Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Belgium · 1 center
- Department of Rehabilitation Sciences, KU Leuven — Leuven
Identifiers
NCT: NCT07366697 · s70965