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

NCT07366697 | Recruiting DMC

• 1 other identifier: s70965
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Upper Limb Motor Impairment; Bimanual Function

Outcome Measures

Primary Outcomes (1)

• Correlation between Ad-AHA Stroke total score and accelerometer-derived Use Ratio

  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.

  Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period

Secondary Outcomes (1)

• Correlation between Ad-AHA Stroke score and composite accelerometer index

  Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period

Other Outcomes (1)

• Correlations between Ad-AHA Stroke score and individual accelerometry-derived features

  Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period

Interventions

Sensor-based monitoring and clinical assessment OTHER

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be adults with chronic stroke (≥ 6 months post-onset) who have observable difficulties in performing bimanual tasks. Participants will be recruited from KU Leuven's rehabilitation network, including university-affiliated rehabilitation centers and outpatient clinics in the Leuven region. All participants will be community-dwelling and medically stable at the time of inclusion.

You may qualify if:

• Written informed consent obtained prior to any study procedures.
• Age between 18 and 80 years (inclusive).
• Unilateral supratentorial stroke involving cortical or subcortical structures.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Department of Rehabilitation Sciences, KU Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Geert Verheyden

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geert Verheyden, PhD

CONTACT

+32 16 32 91 16; geert.verheyden@kuleuven.be

Yue Zou, PhD Candidate

CONTACT

+32 47 12 62 323; yue.zou@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rehabilitation Sciences

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 26, 2026
• Study Start: December 10, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

BE (1)