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Clinical Trial Summary

The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.


Clinical Trial Description

The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months. This will permit us 1) to assess the efficacy of continuing physical therapy sessions during the chronic phase of post-stroke hemiplegia, 2) to investigate whether the effects of physical therapy in these patients gradually decreases during the period of six months to two years post-stroke, and 3) to model the relationship between standard measures of gait performance (speed, endurance, balance, use of technical aids…) with other multidimensional covariates: social and environmental factors (type of housing, presence of a third person,…), cognitive factors (cognitive disorders associated) and thymic factors (anxiety, depression) and 4) to assess the costs associated with the physical therapy care of chronic-phase stroke patients . ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00658710
Study type Interventional
Source Centre Hospitalier Universitaire de Saint Etienne
Contact
Status Terminated
Phase N/A
Start date June 2008
Completion date December 2012

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