CClinicalTrials.gg
CompletedNCT01952522ANANTAUpdated Sep 15, 2025

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

An interventional study of Weighted brace and Non weighted brace in Stroke and Hemiparesis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Stroke
  • Hemiparesis

Browse trials for

Keywords

  • Resistance training
  • Walking
  • Weight bearing
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 42 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Weighted brace

    Behavioral: Weighted brace

  • Placebo comparator
    non weighted brace

    Behavioral: Non weighted brace

Interventions

  • BehavioralWeighted brace

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

  • BehavioralNon weighted brace

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

06

What researchers measure

Primary outcomes

  1. Six minutes walking test

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

    Time frame: 3 months after the inclusion

Secondary outcomes

  1. six minutes walking test

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

    Time frame: 6 months after the inclusion

  2. six minutes walking test

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

    Time frame: 12 months after the inclusion

07

Study locations

1 site
  • Sainte Anne Hospital
    Paris, 75674, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01952522
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre Hospitalier Sainte Anne, Paris, Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Sep 30, 2013
Start date
May 17, 2013
Primary completion
Sep 8, 2016
Completion
Sep 8, 2016
Last update
Sep 15, 2025

Study contacts

Jean-Philippe Regnaux, PhD
study director · French School of Public Health (EHESP)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion