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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Stroke; Non-use of the Paretic Upper Limb
• Intervention / Treatment: Device: Wearing bracelets (3-Axis Logging Accelerometer)

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).

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karima BAKHTI, PhD; Phone Number: +33 0467336111; Email: k-bakhti@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • University Hospital of Montpellier
    • Contact: Karima BAKHTI, PhD; Phone Number: +33 0467336111; Email: k-bakhti@chu-montpellier.fr
  • Nîmes, France, 30900
    • Recruiting
    • Jerome FROGER
    • Contact: Jerome FROGER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemiparetic post-stroke subjects; Stroke patients with motor sequelae in the upper limb.	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.
Other: Healthy subjects; Subjects without stroke.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Université Montpellier; IMT Mines Alès

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): February 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Upper limb; Accelerometry; Functional recovery; Home environment; Real use; Non use
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RECHMPL21_0512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No