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

Stroke Clinical Trial

— ANANTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952522
• Other study ID #: P110702
• Status: Completed
• Phase: N/A
• Start date: May 17, 2013
• Est. completion date: September 8, 2016

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 8, 2016
• Est. primary completion date: September 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

Behavioral:
• Weighted brace
People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
• Non weighted brace
People will be given a brace with no weight they will have to wear all the day during three months.

Locations

Country	Name	City	State
France	Sainte Anne Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Centre Hospitalier Sainte Anne, Paris, Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minutes walking test	Total distance walked in meters (6MWD) within the 6 minutes.	3 months after the inclusion
Secondary	six minutes walking test	Total distance walked in meters (6MWD) within the 6 minutes	6 months after the inclusion
Secondary	six minutes walking test	Total distance walked in meters (6MWD) within the 6 minutes	12 months after the inclusion