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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Walkbot

• Registration Number: NCT02569190
• Lead Sponsor: Veterans Health Service Medical Center, Seoul, Korea

Brief Summary

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-10-04
• Study First Posted: 2015-10-06
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Walkbot	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Trunk control test	at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Functional ambulation category	at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day	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).
Fugl-meyer assessment	at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Medical research council	at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day	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)

Trial Locations

Locations (1)

Veterans Health Service Medical Center; 🇰🇷 Seoul, Gangdong-gu, Korea, Republic of