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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01952522
First Posted: September 30, 2013
Last Update Posted: May 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre Hospitalier Sainte Anne, Paris
Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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).

Condition Intervention Phase
Stroke Hemiparesis Behavioral: Weighted brace Behavioral: Non weighted brace Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Six minutes walking test [ Time Frame: 3 months after the inclusion ]
    Total distance walked in meters (6MWD) within the 6 minutes.


Secondary Outcome Measures:
  • six minutes walking test [ Time Frame: 6 months after the inclusion ]
    Total distance walked in meters (6MWD) within the 6 minutes

  • six minutes walking test [ Time Frame: 12 months after the inclusion ]
    Total distance walked in meters (6MWD) within the 6 minutes


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952522


Contacts
Contact: Florence Colle, MD, PhD f.colle@ch-sainte-anne.fr
Contact: Laurence Lecomte, PhD +331 58 41 35 45 laurence.lecomte@cch.aphp.fr

Locations
France
Sainte Anne Hospital Recruiting
Paris, France, 75674
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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)
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01952522     History of Changes
Other Study ID Numbers: P110702
First Submitted: May 3, 2013
First Posted: September 30, 2013
Last Update Posted: May 5, 2015
Last Verified: April 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Resistance training
Walking
Weight bearing

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms


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