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

NCT ID: NCT05581602

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2025-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Stroke Non-use of the Paretic Upper Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hemiparetic post-stroke subjects

Stroke patients with motor sequelae in the upper limb.

Group Type EXPERIMENTAL

Wearing bracelets (3-Axis Logging Accelerometer)

Intervention Type 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

Subjects without stroke.

Group Type OTHER

Wearing bracelets (3-Axis Logging Accelerometer)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Université Montpellier

OTHER

Sponsor Role collaborator

IMT Mines Alès

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Montpellier

Montpellier, , France

Site Status RECRUITING

Jerome FROGER

Nîmes, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karima BAKHTI, PhD

Role: CONTACT

0467336111 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karima BAKHTI, PhD

Role: primary

0467336111 ext. +33

Jerome FROGER

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL21_0512

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.