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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Upper Limb Motor Impairment; Bimanual Function
• Intervention / Treatment: Other: Sensor-based monitoring and clinical assessment

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 Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Geert Verheyden, PhD; Phone Number: +32 16 32 91 16; Email: geert.verheyden@kuleuven.be
• Study Contact Backup: Name: Yue Zou, PhD Candidate; Phone Number: +32 47 12 62 323; Email: yue.zou@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Department of Rehabilitation Sciences, KU Leuven
    • Contact: Yue Zou, PhD Candidate; Phone Number: +32471262323; Email: yue.zou@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between Ad-AHA Stroke score and composite accelerometer index	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.	Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations between Ad-AHA Stroke score and individual accelerometry-derived features	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.	Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Geert Verheyden, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: s70965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No