Clinical trial NCT05581602: Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Non-use of the Paretic Upper Limb
Keywords: Accelerometry
Stroke
Upper limb
Functional recovery
Home environment
Rehabilitation
Real use
Non use
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
name: IMT Mines Alès
First posted: 2022-10-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first phase of this project is a bicentric cross-sectional study in 30 hemiparetic post-stroke subjects in chronic phase and 30 healthy subjects, age and gender matched.

The second phase is a 6-month longitudinal study, in a subgroup of 5 post-stroke subjects.
Primary purpose: SUPPORTIVE_CARE

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).

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)

Primary outcomes:
measure: FuncUseRatio
timeFrame: 7 days
Secondary outcomes:
measure: Use
timeFrame: 7 days
measure: Intensity
timeFrame: 7 days
measure: Profil
timeFrame: During intervention
measure: Motor deficit
timeFrame: During the inclusion visit or information taken in the medical file
measure: Dispersion of UseRatio
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nîmes
country: France
facility: Jerome FROGER
Study officials:
References: