Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 25, 2014
Last verified: July 2014

May 3, 2013
July 25, 2014
May 2013
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01952522 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiparesis
  • 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
  • Behavioral: Non weighted brace
    People will be given a brace with no weight they will have to wear all the day during three months.
  • Experimental: Weighted brace
    Intervention: Behavioral: Weighted brace
  • Placebo Comparator: non weighted brace
    Intervention: Behavioral: Non weighted brace
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01952522
P110702
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • Centre Hospitalier Sainte Anne, Paris
  • Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
Study Director: Jean-Philippe Regnaux, PhD French School of Public Health (EHESP)
Assistance Publique - Hôpitaux de Paris
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP