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

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Weighted brace
Non weighted brace
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Resistance training, Walking, Weight bearing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sainte Anne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Weighted brace

non weighted brace

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2013
Last Updated
November 19, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre Hospitalier Sainte Anne, Paris, Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01952522
Brief Title
Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke
Acronym
ANANTA
Official Title
Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2013 (undefined)
Primary Completion Date
September 8, 2016 (Actual)
Study Completion Date
September 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre Hospitalier Sainte Anne, Paris, Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Resistance training, Walking, Weight bearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weighted brace
Arm Type
Experimental
Arm Title
non weighted brace
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Weighted brace
Intervention Description
People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
Intervention Type
Behavioral
Intervention Name(s)
Non weighted brace
Intervention Description
People will be given a brace with no weight they will have to wear all the day during three months.
Primary Outcome Measure Information:
Title
Six minutes walking test
Description
Total distance walked in meters (6MWD) within the 6 minutes.
Time Frame
3 months after the inclusion
Secondary Outcome Measure Information:
Title
six minutes walking test
Description
Total distance walked in meters (6MWD) within the 6 minutes
Time Frame
6 months after the inclusion
Title
six minutes walking test
Description
Total distance walked in meters (6MWD) within the 6 minutes
Time Frame
12 months after the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Regnaux, PhD
Organizational Affiliation
French School of Public Health (EHESP)
Official's Role
Study Director
Facility Information:
Facility Name
Sainte Anne Hospital
City
Paris
ZIP/Postal Code
75674
Country
France

12. IPD Sharing Statement

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

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