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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07366697
Enrollment
32
Registered
2026-01-26
Start date
2025-12-10
Completion date
2026-07-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bimanual Function, Stroke, Upper Limb Motor Impairment

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.

Interventions

OTHERSensor-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.

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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 ≤ 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).

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Ad-AHA Stroke total score and accelerometer-derived Use RatioBaseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring periodThe 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

MeasureTime frameDescription
Correlation between Ad-AHA Stroke score and composite accelerometer indexBaseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring periodThe secondary endpoint is the correlation between Ad-AHA Stroke scores and a composite accelerometer index derived from multiple sensor-based features (e.g., Use Ratio, Activity Symmetry Index, Bimanual Bouts, Percentage of Bimanual Time, Median Bilateral Magnitude, Median Magnitude Ratio). The composite index will be constructed using feature selection techniques (e.g., principal component analysis or correlation-based filtering). Spearman's ρ will be used to examine the strength of the association.

Countries

Belgium

Contacts

CONTACTGeert Verheyden, PhD
geert.verheyden@kuleuven.be+32 16 32 91 16
CONTACTYue Zou, PhD Candidate
yue.zou@kuleuven.be+32 47 12 62 323
PRINCIPAL_INVESTIGATORGeert Verheyden

KU Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026