Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients "HEMIMARCHE"

Terminated

Phase N/A Results N/A

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.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.

Detailed 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 .

Conditions

Interventions

  • Physical therapy sessions Behavioral
    Intervention Desc: two physical therapy sessions per week for two months
    ARM 1: Kind: Experimental
    Label: 1
    Description: patients who continue physical therapy sessions during two months.
    ARM 2: Kind: Experimental
    Label: 2
    Description: patients who stop physical therapy sessions during two months

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary the average number of steps per day recorded over 3 days in an outpatient setting day 3 and then 6 months later No
Secondary the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score) day 0 and then day 55 No
Secondary for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients 6 months No

Sponsors