Skip to content

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

Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01952522
Acronym
ANANTA
Enrollment
42
Registered
2013-09-30
Start date
2013-05-17
Completion date
2016-09-08
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis, Stroke

Keywords

Resistance training, Walking, Weight bearing

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.

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.

Sponsors

Centre Hospitalier Sainte Anne, Paris
CollaboratorUNKNOWN
Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Six minutes walking test3 months after the inclusionTotal distance walked in meters (6MWD) within the 6 minutes.

Secondary

MeasureTime frameDescription
six minutes walking test6 months after the inclusionTotal distance walked in meters (6MWD) within the 6 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026