Effect of Robot-assisted Gait Training on Brain Reorganization in Hemiplegic Patients

Completed

Phase N/A Results N/A

Trial Description

Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.

Detailed Description

This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.

Conditions

Interventions

  • Walkbot Device
    Intervention Desc: Robot assisted gait training
    ARM 1: Kind: Experimental
    Label: Walkbot
    Description: Receive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention at the first day of intervention and 8 weeks after the first day Yes
Secondary Functional ambulation category at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day Yes
Secondary Fugl-meyer assessment at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day Yes
Secondary Medical research council at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day Yes
Secondary Trunk control test at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day Yes

Sponsors