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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05581602
Other study ID # RECHMPL21_0512
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 13, 2023
Est. completion date August 20, 2025

Study information

Verified date January 2024
Source University Hospital, Montpellier
Contact Karima BAKHTI, PhD
Phone 0467336111
Email k-bakhti@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). The investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.


Description:

After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date August 20, 2025
Est. primary completion date February 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: Inclusion criteria common to all participants: - Be between 18 and 90 years old 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 Exclusion Criteria: Non inclusion criteria common to all participants: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
France University Hospital of Montpellier Montpellier
France Jerome FROGER Nîmes

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Montpellier IMT Mines Alès, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary FuncUseRatio The paretic functional use score is a ratio of functional movements performed by the paretic upper limb to the sum of functional movements performed by the paretic and non-paretic upper limbs (in percentage %). 7 days
Secondary Use Measurement of the amount of functional movement of each upper limb, in an ecological situation during activities of daily living of post-stroke and healthy subjects. 7 days
Secondary Intensity Measurement of the intensity of movements (functional and non-functional) of each upper limb, in an ecological situation during activities of daily living of post-stroke and healthy subjects. 7 days
Secondary Profil The activity log is presented in the form of a table. The columns represent the days of recording (Day 1 => Day 7), the rows represent the time slots hour by hour During intervention
Secondary Motor deficit Motor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE) During the inclusion visit or information taken in the medical file
Secondary Dispersion of UseRatio The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range 6 months
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