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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569190
• Other study ID #: 2015-05-008-002
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: April 28, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Veterans Health Service Medical Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Walkbot
Robot assisted gait training

Locations

Country	Name	City	State
Korea, Republic of	Veterans Health Service Medical Center	Seoul	Gangdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Veterans Health Service Medical Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	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
Secondary	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
Secondary	Fugl-meyer assessment		at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day
Secondary	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
Secondary	Trunk control test		at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day