Clinical trial NCT01952522: Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke
Official title: Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Resistance training
Walking
Weight bearing
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Sainte Anne, Paris
name: Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
First posted: 2013-09-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Six minutes walking test
timeFrame: 3 months after the inclusion
Secondary outcomes:
measure: six minutes walking test
timeFrame: 6 months after the inclusion
measure: six minutes walking test
timeFrame: 12 months after the inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Sainte Anne Hospital
Study officials:
affiliation: French School of Public Health (EHESP)
name: Jean-Philippe Regnaux, PhD
role: STUDY_DIRECTOR
References: