Robot-assisted Gait Training for Patients With Stroke

Recruiting

Phase N/A Results N/A

Trial Description

Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.

Detailed Description

Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.

Conditions

Interventions

  • Standard rehab Other
    Intervention Desc: Standard hospital based rehabilitation for patients with stroke
    ARM 1: Kind: Experimental
    Label: Standard Rehabilitation
    Description: Patient with stroke receiving standard hospital based rehabilitation program
  • Robot-assisted gait rehabilitation Device
    Intervention Desc: An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke
    ARM 1: Kind: Experimental
    Label: Robot-assisted Rehabilitation
    Description: Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment, lower extremity subscale Assessing change from baseline after 1 month of intervention No
Secondary Functional Ambulation Categories Assessing change from baseline after 1 month of intervention No
Secondary 10 Meters Walking Test Assessing change from baseline after 1 month of intervention No
Secondary Berg Balance Scale Assessing change from baseline after 1 month of intervention No
Secondary Timed Up and Go test Assessing change from baseline after 1 month of intervention No
Secondary Kinetic and Kinematic Gait Analysis Assessing change from baseline after 1 month of intervention No

Sponsors