Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke (ANANTA)
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|ClinicalTrials.gov Identifier: NCT01952522|
Recruitment Status : Unknown
Verified April 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : September 30, 2013
Last Update Posted : May 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Behavioral: Weighted brace Behavioral: Non weighted brace||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
|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.
- Six minutes walking test [ Time Frame: 3 months after the inclusion ]Total distance walked in meters (6MWD) within the 6 minutes.
- 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
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
|Contact: Florence Colle, MD, PhDfirstname.lastname@example.org|
|Contact: Laurence Lecomte, PhD||+331 58 41 35 email@example.com|
|Sainte Anne Hospital||Recruiting|
|Paris, France, 75674|
|Study Director:||Jean-Philippe Regnaux, PhD||French School of Public Health (EHESP)|