Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

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 acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

Detailed Description

Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

Conditions

Interventions

  • HIWIN Robotic Gait Training System Device
    Intervention Desc: HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
    ARM 1: Kind: Experimental
    Label: Robotic Gait Training
    Description: Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training
  • Static Standing Table Other
    Intervention Desc: As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
    ARM 1: Kind: Experimental
    Label: Static Standing Table Training
    Description: Patients in this group will receive standard hospital based rehabilitation as well as static standing table training

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Berg Balance Scale 15-20 minutes No
Secondary Pittsburgh Sleep Quality Index 10-15 minutes No
Secondary EuroQol five dimensions questionnaire (EQ-5D) 10-15 minutes No
Secondary Resting muscle tone 10 minutes No
Secondary Resting muscle elasticity 10 minutes No
Secondary Six minute walk test 6 minutes No
Secondary Beck's depression Inventory 7-10 minutes No

Sponsors