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

NCT05581602 | Unknown

• 1 other identifier: RECHMPL21_0512
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Stroke; Non-use of the Paretic Upper Limb

Keywords

Accelerometry; Stroke; Upper limb; Functional recovery; Home environment; Rehabilitation; Real use; Non use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Use

  7 days

• Intensity

  7 days

• Profil

  During intervention

• Motor deficit

  During the inclusion visit or information taken in the medical file

• Dispersion of UseRatio

  6 months

Study Arms (2)

Hemiparetic post-stroke subjects

EXPERIMENTAL

Stroke patients with motor sequelae in the upper limb.

Device: Wearing bracelets (3-Axis Logging Accelerometer)

Healthy subjects

OTHER

Subjects without stroke.

Device: Wearing bracelets (3-Axis Logging Accelerometer)

Interventions

Wearing bracelets (3-Axis Logging Accelerometer) DEVICE

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.

Healthy subjects; Hemiparetic post-stroke subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator
• IMT Mines Alès: collaborator

Study Sites (2)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

Jerome FROGER

Nîmes, 30900, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Karima BAKHTI, PhD

CONTACT

0467336111; k-bakhti@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: February 13, 2023
• Primary Completion: February 20, 2025
• Study Completion: August 20, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)