Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke

NCT ID: NCT01952522

Last Updated: 2025-09-15

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-17

Study Completion Date

2016-09-08

Brief Summary

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This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight).

Detailed Description

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Improve walking ability in people after stroke is a key objective for rehabilitation. Once the rehabilitation period is finished, a reduction of functional and motor abilities is often observed in subjects when they returned home.

This study will examine if loading daily the non paretic leg with additional weights will improve walking abilities. This study will enroll 100 people who had a stroke \> three months and \< five years and who still experienced difficulties for walking.

Each patient will receive 3 months of intervention targeting their non affected leg. Half of the subjects will have to wear braces with additional weights at the non affected ankle during the day ( \> 6 hours), while the other half will wear a similar brace but without weight.

A six minutes walking test will be given before and after the intervention, as well six and twelve months later to measure the effect of these interventions. The investigators hypothesize that people receiving the additional weights to the non paretic leg will show greater improvements in their walk abilities.

Conditions

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Stroke Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Weighted brace

Group Type EXPERIMENTAL

Weighted brace

Intervention Type BEHAVIORAL

People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months

non weighted brace

Group Type PLACEBO_COMPARATOR

Non weighted brace

Intervention Type BEHAVIORAL

People will be given a brace with no weight they will have to wear all the day during three months.

Interventions

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Weighted brace

People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months

Intervention Type BEHAVIORAL

Non weighted brace

People will be given a brace with no weight they will have to wear all the day during three months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hemiparesis following ischemic or hemorrhagic infarct of a single hemisphere
* First episode of stroke experienced \> 3 months and \< 5 years prior to study enrolment
* Functional Ambulation Categories (FAC) score \> 3 \< 8
* Be able to walk few meters without physical assistance
* Able to understand and follow instructions

Exclusion Criteria

* Following inpatient physical rehabilitation
* Experienced more than 2 falls during 3 months prior inclusion
* Signs of bilateral impairments
* Daily use of a wheelchair to move
* Contra-indications for daily walk
* Currently participating in any clinical trial with a experimental walking intervention
* Severe arthrosis
* Dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sainte Anne, Paris

UNKNOWN

Sponsor Role collaborator

Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris

UNKNOWN

Sponsor Role collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe Regnaux, PhD

Role: STUDY_DIRECTOR

French School of Public Health (EHESP)

Locations

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Sainte Anne Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P110702

Identifier Type: -

Identifier Source: org_study_id

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