Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.

Detailed Description

Randomized, two treatment groups
Number of Subjects : 54 subjects (n=27 per group)
Group 1 : gait rehabilitation with hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session
Group 2 : gait rehabilitation without hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session
Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and foot pressure distribution measured by F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA).
Secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by Berg Balance Scale (BBS), Tinetti performance oriented mobility assessment (POMA), Korean version Modified Bathel index (K-MBI), Modified Rankin Scale (MRS), Functional Ambulation Classification (FAC), Fugl-Meyer assessment for lower extremity (FMA), Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).

Conditions

Interventions

  • Gait rehabilitation with Samsung Hip Assist v1 Device
    Intervention Desc: Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
    ARM 1: Kind: Experimental
    Label: Samsung Hip Assist v1
    Description: gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session
  • Gait rehabilitation without Samsung Hip Assist v1 Other
    Intervention Desc: Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
    ARM 1: Kind: Experimental
    Label: Conventional gait training
    Description: gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in 10 meter walk test from baseline in gait speed session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Berg Balance Scale (BBS) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Tinetti performance oriented mobility assessment (POMA) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Modified Bathel index (MBI) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Modified Rankin Scale (MRS) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Functional Ambulation Classification (FAC) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Fugl-Meyer assessment for lower extremity (FMA) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Fall Efficacy Scale (FES) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Manual Muscle Test (MMT) session 0 (initial visit); session 11 (at approximately 4 weeks) No
Secondary Range of Motion (ROM) session 0 (initial visit); session 11 (at approximately 4 weeks) No

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