Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Chronic Stroke, Non-use of the Paretic Upper Limb

Intervention / Treatment
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* Device: Wearing bracelets (3-Axis Logging Accelerometer)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemiparetic post-stroke subjects<br>Stroke patients with motor sequelae in the upper limb. | Device: Wearing bracelets (3-Axis Logging Accelerometer)<br>* 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.<br>|
| Other: Healthy subjects<br>Subjects without stroke. | Device: Wearing bracelets (3-Axis Logging Accelerometer)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Dispersion of UseRatio | The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accelerometry, Stroke, Upper limb, Functional recovery, Home environment, Rehabilitation, Real use, Non use