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Completed

NCT Number: NCT06509542

Measuring the Concurrent Validity of the Upper Limb Use Ratio With Accelerometers in an Ecological Situation After Stroke.

The purpose of this stufy is to measure the concurrent validity of the upper limb use ratio with accelerometers in an ecological situation after stroke.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Paul Coste Floret, Lamalou-les-Bains, France

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About this study

The first visit will be used to present the study and potential risks to patients, obtain their consent and collect clinical data. A second visit is planned for the patients who meet the eligibility requirements, to carry out activities in ecological situation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject with hemiparesis following stroke
  • Subject participating in ecological activities during occupational therapy sessions
  • Adult subject aged 18 or over
  • Subject informed of study participation and not objecting to participation

Exclusion criteria

  • Other neurological or musculoskeletal disorders limiting use of upper limbs
  • Pregnant or breast-feeding woman,
  • Failure to obtain consent,
  • Non-affiliation with a social security scheme,
  • Persons under court protection,
  • Person protected by law (under guardianship or curatorship)
  • Participant in another research project with an exclusion period still ongoing.

Treatment and study plan

Objective assessment of upper limb use during activities in ecological situation

Behavioral

Twenty-five patients will be recorded performing three activities during their rehabilitation: getting dressed, preparing a meal, and eating a meal. The movements of their upper limbs will be tracked using wrist-worn accelerometers and video cameras.

Primary outcomes

  1. Concurrent validity (Intraclass Correlation Coefficient) of FuncUseRatio, using wrist-worn accelerometers, compared with the FuncUseRatio measured by video analysis.

    Time frame: Baseline

    FuncUseRatio is the ratio of functional use of the paretic upper arm to the non-paretic upper arm measured by two methods (actimetry and video analysis),during the same occupational therapy sessions simulating activities of daily living with hemiparetic patients.

Secondary outcomes

  1. Number of functional movements performed with the upper limbs (FuncUse30)

    Time frame: Baseline

    The functional movements are the movements with an amplitude greater than 30° within a spatial range of -30° to +30° around the horizontal, measured over a two-second time window (FuncUse30)

  2. Ratio of the acceleration vector magnitude

    Time frame: Baseline

    The magnitude of the acceleration vector is the norm of the acceleration vector (SVM: Scalar Vector Magnitude) minus 1 for the gravitational force. The ratio between the paretic and non paretic arm is then calculated

  3. Activity count ratio

    Time frame: Baseline

    The activity count is the magnitude of the acceleration vector summed per second for each arm, and converted into an activity count (0.01664g/count). The ratio between the paretic and the non-paretic arm is then calculated.

  4. Activity time ratio

    Time frame: Baseline

    The activity time is the sum of the seconds of arm activity for each arm. The ratio between the paretic and the non-paretic arm is then calculated.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Paul Coste Floret Hospital
  • Université Montpellier

Registry information

Official study title

Measuring the Concurrent Validity of the Upper Limb Use Ratio With Accelerometers in an Ecological Situation After Stroke. ValidFUR

Acronym: ValidFUR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Apr 13, 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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