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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Walkbot

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangdong-gu
    • Seoul, Gangdong-gu, Korea, Republic of, 05368
      • Veterans Health Service Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First stroke attack
• Within 3 months after stroke onset
• Supratentorial stroke
• Unilateral stroke

Exclusion Criteria:

• Bilateral stroke
• infratentorial stroke
• Cognitive disabilities or serious psychiatric illness.
• Difficulty in walking due to orthopedic problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walkbot; Receive conventional physical therapy (session I for 30 min/day) with Walkbot training 3 days a week for 8 weeks, 20 session in all.	Device: Walkbot; Robot assisted gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional ambulation category	The functional ambulation category was designed to examine the levels of assistance required during a 15m walk. Six categories are included in the functional ambulation category: 0 (non-ambulatory), 1 (needs continuous support from one person), 2 (needs intermittent support from one person), 3 (needs only verbal supervision), 4 (help is required on stairs and uneven surfaces), and 5 (can walk independently anywhere).	at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Fugl-meyer assessment		at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Medical research council	The medical research council was designed to examine the muscle strength. Six categories are included in the medical research council: 5 (muscle contracts normally against full resistance), 4 (muscle strength is reduced but muscle contraction can still move joint against resistance), 3 (muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side), 2 (muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane), 1 (only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle) and 0 (no movement is observed)	at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Trunk control test		at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day

Collaborators and Investigators

• Sponsor: Veterans Health Service Medical Center, Seoul, Korea
• Investigators: Principal Investigator: Dae Hyun Kim, Master, Veterans hospital, Seoul, Republic of Korea

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: October 4, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Estimate): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015-05-008-002