Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients "Walkbot"

Completed

Phase N/A Results N/A

Trial Description

A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Detailed Description

Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.
Experimental group receives robot-assisted-gait-training and conventional gait training.
Active comparator group receives conventional gait training only as the same number as the experimental group.

Conditions

Interventions

  • Conventional Physical Therapy Device
    Intervention Desc: Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
    ARM 1: Kind: Experimental
    Label: Walkbot
    Description: Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
    ARM 2: Kind: Experimental
    Label: Conventional physical therapy
    Description: Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
  • Conventional gait training Other
    Intervention Desc: Conventional gait training 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
    ARM 1: Kind: Experimental
    Label: Walkbot
    Description: Walkbot(robot assisted gait training) 30 minutes and conventional gait training 30 minutes each per day to be administered 5 times a week for 3 weeks.
    ARM 2: Kind: Experimental
    Label: Conventional gait training group
    Description: Conventional gait training 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
  • Walkbot Device
    Intervention Desc: Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
    ARM 1: Kind: Experimental
    Label: Walkbot
    Description: Walkbot(robot assisted gait training) 30 minutes and conventional gait training 30 minutes each per day to be administered 5 times a week for 3 weeks.

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 Functional Ambulation Category(FAC) 9 weeks from baseline No
Secondary Motricity Index(MI) 9 weeks from baseline No
Secondary 10 Meter Walk Test(10MWT) 9 weeks from baseline No
Secondary 6 Minute Walk Test(6MWT) 9 weeks from baseline No
Secondary Medical Research Council(MRC) Scale 9 weeks from baseline No
Secondary Modified Ashworth Scale (MAS) 9 weeks from baseline No
Secondary Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke 9 weeks from baseline No
Secondary Modified Barthel Index(MBI) 9 weeks from baseline No
Secondary National Institutes of Health Stroke Scale (NIHSS) 9 weeks from baseline No
Secondary Beck's Depression Inventory test (BDI) 9 weeks from baseline No
Secondary Treatment Satisfaction Survey 9 weeks from baseline No

Sponsors