Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)

Terminated

Phase N/A Results N/A

Trial Description

Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.

Detailed Description

Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.
The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.

Conditions

Interventions

  • Gait Trainer Device
    Intervention Desc: Mechanical gait repetitive training
    ARM 1: Kind: Experimental
    Label: Mechanical gait repetitive training
    Description: Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement
  • Conventional rehabilitation Procedure
    Intervention Desc: Physiotherapeutic conventional rehabilitation
    ARM 1: Kind: Experimental
    Label: Conventional rehabilitation program
    Description: Physiotherapeutic conventional rehabilitation program

Trial Design

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

Patient Involvement

Patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.

Outcomes

Type Measure Time Frame Safety Issue
Primary Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program.
Secondary Functional ambulatory category, walking endurance (6 minute walk), time to self sufficient gait recovery, spasticity (modified Ashworth score), motricity index, need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance), and economic evaluation (healthcare requirements, rehabilitaion unit lenght of stay).
Primary Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program after 4 weeks
Secondary Functional ambulatory category
Secondary Walking endurance (6 minute walk)
Secondary Time to self sufficient gait recovery
Secondary Spasticity (modified Ashworth score)
Secondary Motricity index
Secondary Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)
Secondary Economic evaluation (healthcare requirements, rehabilitaion unit lenght of stay)
Secondary Economic evaluation (healthcare requirements, rehabilitation unit length of stay) At the end of the study No

Sponsors