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Completed

NCT Number: NCT01952522

Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sainte Anne Hospital

Paris, 75674, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weighted brace

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

Behavioral

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

Primary outcomes

  1. Six minutes walking test

    Time frame: 3 months after the inclusion

    Total distance walked in meters (6MWD) within the 6 minutes.

Secondary outcomes

  1. six minutes walking test

    Time frame: 6 months after the inclusion

    Total distance walked in meters (6MWD) within the 6 minutes

  2. six minutes walking test

    Time frame: 12 months after the inclusion

    Total distance walked in meters (6MWD) within the 6 minutes

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Centre Hospitalier Sainte Anne, Paris
  • Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: ANANTA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2013
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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