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NCT Number: NCT07366697

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

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.

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Key information

Conditions

Stroke Bimanual Function Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Upper Limb Motor Impairment Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rehabilitation Sciences, KU Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Yue Zou, PhD Candidate

CONTACT

[email protected]

+32471262323

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

  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

    The 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.

Other outcomes

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

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

    Exploratory analyses will examine the associations between Ad-AHA Stroke total scores and individual accelerometer-derived features, including Activity Symmetry Index (ASI), Number of Bimanual Bouts, Percentage of Bimanual Time, Median Bilateral Magnitude, and Median Magnitude Ratio (MMR). Each metric captures a different dimension of bimanual use symmetry and intensity. Associations will be analyzed using Pearson's r or Spearman's ρ, depending on data distribution.

Study contacts

Contact information is provided by the study sponsor or research team.

Geert Verheyden, PhD

CONTACT

[email protected]

+32 16 32 91 16

Yue Zou, PhD Candidate

CONTACT

[email protected]

+32 47 12 62 323

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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