NCT01952522

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2013

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

May 17, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2016

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

May 3, 2013

Last Update Submit

September 8, 2025

Conditions

StrokeHemiparesis

Keywords

Resistance trainingWalkingWeight bearing

Outcome Measures

Primary Outcomes (1)

  • Six minutes walking test

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

    3 months after the inclusion

Secondary Outcomes (2)

  • six minutes walking test

    6 months after the inclusion

  • six minutes walking test

    12 months after the inclusion

Study Arms (2)

Weighted brace

EXPERIMENTAL
Behavioral: Weighted brace

non weighted brace

PLACEBO COMPARATOR
Behavioral: Non weighted brace

Interventions

Weighted braceBEHAVIORAL

People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months

Weighted brace
Non weighted braceBEHAVIORAL

People will be given a brace with no weight they will have to wear all the day during three months.

non weighted brace

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Following inpatient physical rehabilitation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sainte Anne Hospital

Paris, 75674, France

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Philippe Regnaux, PhD

    French School of Public Health (EHESP)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

September 30, 2013

Study Start

May 17, 2013

Primary Completion

September 8, 2016

Study Completion

September 8, 2016

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations

FR(1)