StrokeNCT07366697
Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures
An observational study of Stroke and Upper Limb Motor Impairment, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Upper Limb Motor Impairment, Bimanual Function
- What is being tested?
- Sensor-based monitoring and clinical assessment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Dec 2025to Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Sciences, KU Leuven
Leuven, 3000
Yue Zou, PhD Candidate, +32471262323, yue.zou@kuleuven.be
About this study
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.
Read the 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.
- Conditions
- Stroke, Upper Limb Motor Impairment, Bimanual Function
- Being tested
- Sensor-based monitoring and clinical assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-based monitoring and clinical assessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start10 Dec 2025
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Geert Verheyden, KU Leuven
- Investigators
- Geert Verheyden, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366697
- Sponsor's protocol ID
- s70965
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided