Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.
NCT ID: NCT05581602
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-02-13
2025-08-20
Brief Summary
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The investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.
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Detailed Description
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Project will monitor 30 chronic and 30 healthy subjects over one week period using two wrist worn sensors .
The main objective is to objectively quantify by actimetry, over 7 days, the real functional use of the paretic upper limb in the activities of daily living of post-stroke hemiparetic subjects in chronic phase, by the functional use ratio between the two arms (UseRatio).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
The second phase is a 6-month longitudinal study, in a subgroup of 5 post-stroke subjects.
SUPPORTIVE_CARE
NONE
Study Groups
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Hemiparetic post-stroke subjects
Stroke patients with motor sequelae in the upper limb.
Wearing bracelets (3-Axis Logging Accelerometer)
Participants will be required to wear wristbands containing an accelerometer on each wrist. The bracelets will be kept on both wrists for 7 days with permission to remove them from time to time.
Healthy subjects
Subjects without stroke.
Wearing bracelets (3-Axis Logging Accelerometer)
Participants will be required to wear wristbands containing an accelerometer on each wrist. The bracelets will be kept on both wrists for 7 days with permission to remove them from time to time.
Interventions
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Wearing bracelets (3-Axis Logging Accelerometer)
Participants will be required to wear wristbands containing an accelerometer on each wrist. The bracelets will be kept on both wrists for 7 days with permission to remove them from time to time.
Eligibility Criteria
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Inclusion Criteria
Post-stroke subjects should:
* Having a stroke with motor sequelae in the upper limb
* Be in the chronic phase (\>3 months post-stroke) of a stroke whatever the aetiology
* Absence of free, informed and express oral consent
* No affiliation to a French social security system or beneficiary of such a system
* Patient protected by law
* Pregnant or breastfeeding women
Not eligible for inclusion, post-stroke subjects:
* Not understanding the constraints of the study
* Have cognitive impairments that prevent them from understanding the study
* With a known hemigligence in the medical record (omission \> 8 on bells test)
18 Years
90 Years
ALL
Yes
Sponsors
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Université Montpellier
OTHER
IMT Mines Alès
UNKNOWN
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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University Hospital of Montpellier
Montpellier, , France
Jerome FROGER
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Jerome FROGER
Role: primary
Other Identifiers
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RECHMPL21_0512
Identifier Type: -
Identifier Source: org_study_id
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