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Clinical Trials/NCT05581602
NCT05581602
Recruiting
Not Applicable

Actimeric Monitoring of the Use of the Paretic Upper Limb in the Activities of Daily Living of the Post-chronic Stroke Subject in a Home Environment

University Hospital, Montpellier2 sites in 1 country66 target enrollmentFebruary 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
University Hospital, Montpellier
Enrollment
66
Locations
2
Primary Endpoint
FuncUseRatio
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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).

Registry
clinicaltrials.gov
Start Date
February 13, 2023
End Date
August 20, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

FuncUseRatio

Time Frame: 7 days

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 %).

Secondary Outcomes

  • Use(7 days)
  • Intensity(7 days)
  • Motor deficit(During the inclusion visit or information taken in the medical file)
  • Dispersion of UseRatio(6 months)
  • Profil(During intervention)

Study Sites (2)

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