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

Not Applicable

Completed

• Conditions: Hemiparesis; Stroke
• Interventions: Behavioral: Non weighted brace; Behavioral: Weighted brace

• Registration Number: NCT01952522
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-05-03
• Study Start: 2013-05-17
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-30
• Primary Completion: 2016-09-08
• Study Completion: 2016-09-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non weighted brace	Non weighted brace	-
Weighted brace	Weighted brace	-

Primary Outcome Measures

Name	Time	Method
Six minutes walking test	3 months after the inclusion	Total distance walked in meters (6MWD) within the 6 minutes.

Secondary Outcome Measures

Name	Time	Method
six minutes walking test	12 months after the inclusion	Total distance walked in meters (6MWD) within the 6 minutes

Trial Locations

Locations (1)

Sainte Anne Hospital; 🇫🇷 Paris, France