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

This study is currently recruiting participants.
Verified August 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Centre Hospitalier Sainte Anne, Paris
Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01952522
First received: May 3, 2013
Last updated: September 24, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    Total distance walked in meters (6MWD) within the 6 minutes.


Secondary Outcome Measures:
  • six minutes walking test [ Time Frame: 6 months after the inclusion ] [ Designated as safety issue: No ]
    Total distance walked in meters (6MWD) within the 6 minutes

  • six minutes walking test [ Time Frame: 12 months after the inclusion ] [ Designated as safety issue: No ]
    Total distance walked in meters (6MWD) within the 6 minutes


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 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 < two 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 < 2 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01952522     History of Changes
Other Study ID Numbers: P110702
Study First Received: May 3, 2013
Last Updated: September 24, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014