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

Primary Purpose

Chronic Stroke, Non-use of the Paretic Upper Limb

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Wearing bracelets (3-Axis Logging Accelerometer)
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Stroke focused on measuring Accelerometry, Stroke, Upper limb, Functional recovery, Home environment, Rehabilitation, Real use, Non use

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University Hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hemiparetic post-stroke subjects

Healthy subjects

Arm Description

Stroke patients with motor sequelae in the upper limb.

Subjects without stroke.

Outcomes

Primary Outcome Measures

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 %).

Secondary Outcome Measures

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.
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.
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
Motor deficit
Motor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE)
Dispersion of UseRatio
The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range

Full Information

First Posted
October 11, 2022
Last Updated
February 13, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier, IMT Mines Alès
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1. Study Identification

Unique Protocol Identification Number
NCT05581602
Brief Title
Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.
Acronym
ParUse
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
August 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier, IMT Mines Alès

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Non-use of the Paretic Upper Limb
Keywords
Accelerometry, Stroke, Upper limb, Functional recovery, Home environment, Rehabilitation, Real use, Non use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemiparetic post-stroke subjects
Arm Type
Experimental
Arm Description
Stroke patients with motor sequelae in the upper limb.
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
Subjects without stroke.
Intervention Type
Device
Intervention Name(s)
Wearing bracelets (3-Axis Logging Accelerometer)
Intervention Description
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.
Primary Outcome Measure Information:
Title
FuncUseRatio
Description
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 %).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Use
Description
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.
Time Frame
7 days
Title
Intensity
Description
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.
Time Frame
7 days
Title
Profil
Description
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
Time Frame
During intervention
Title
Motor deficit
Description
Motor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE)
Time Frame
During the inclusion visit or information taken in the medical file
Title
Dispersion of UseRatio
Description
The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karima BAKHTI, PhD
Phone
0467336111
Ext
+33
Email
k-bakhti@chu-montpellier.fr
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karima BAKHTI, PhD
Phone
0467336111
Ext
+33
Email
k-bakhti@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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