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

November 19, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75674
        • Sainte Anne Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weighted brace
Behavioral: Weighted brace
People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
Placebo Comparator: non weighted brace
Behavioral: Non weighted brace
People will be given a brace with no weight they will have to wear all the day during three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minutes walking test
Time Frame: 3 months after the inclusion
Total distance walked in meters (6MWD) within the 6 minutes.
3 months after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
six minutes walking test
Time Frame: 6 months after the inclusion
Total distance walked in meters (6MWD) within the 6 minutes
6 months after the inclusion
six minutes walking test
Time Frame: 12 months after the inclusion
Total distance walked in meters (6MWD) within the 6 minutes
12 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Centre Hospitalier Sainte Anne, Paris
Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris

Investigators

  • Study Director: Jean-Philippe Regnaux, PhD, French School of Public Health (EHESP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 17, 2013

Primary Completion (Actual)

September 8, 2016

Study Completion (Actual)

September 8, 2016

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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