Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Chronic Stroke

Sponsor

National Rehabilitation Center, Seoul, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT04005131

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation in subjects with chronic stroke - delayed start study.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Robot and tDCS on-line Device: Robot and tDCS on-line after sham tDCS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Participant does not know the allocation.

Primary Purpose:

Treatment

Official Title:

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Chronic Stroke

Actual Study Start Date :

May 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot and tDCS on-line Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 10 weeks	Device: Robot and tDCS on-line Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 10 weeks
Active Comparator: Robot and tDCS on-line after sham tDCS Combined sham tDCS and upper extremity rehabilitation robot for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 weeks	Device: Robot and tDCS on-line after sham tDCS Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 times a week for 5 weeks

Arm

Intervention/Treatment

Experimental: Robot and tDCS on-line

Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 10 weeks

Device: Robot and tDCS on-line

Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 10 weeks

Active Comparator: Robot and tDCS on-line after sham tDCS

Combined sham tDCS and upper extremity rehabilitation robot for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 weeks

Device: Robot and tDCS on-line after sham tDCS

Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 times a week for 5 weeks

Outcome Measures

Primary Outcome Measures

kinematic data during scale for the assessment [5 weeks after baseline]
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)

Secondary Outcome Measures

kinematic data during scale for the assessment [baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline]
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
Fugl-Meyer Assessment - upper extremity [baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline]
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
Wolf Motor Function Test [baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline]
an activity indicator, has 15 items for testing functional ability
Motor activity log [baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline]
Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.
Action reach arm test [baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline]
to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hemiplegic patients secondary to first cerebrovascular accidents
Onset ≥ 6 months
Fugl-Meyer Assessment score ≥ 19
Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

Severe upper extremity pain that could interfere with rehabilitation therapy
Neurological disorders other than stroke that can cause motor deficits
Uncontrolled severe medical conditions.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Rehabilitation Center	Seoul		Korea, Republic of	142884

Sponsors and Collaborators

National Rehabilitation Center, Seoul, Korea

Investigators

Principal Investigator: Joon-Ho Shin, National Rehabilitation Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea

ClinicalTrials.gov Identifier:

NCT04005131

Other Study ID Numbers:

NRC-2018-01-003

First Posted:

Jul 2, 2019

Last Update Posted:

Jul 2, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joon-Ho Shin, Team manager, National Rehabilitation Center, Seoul, Korea

stroke

transcranial direct current stimulation

upper extremity rehabilitation robot

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 2, 2019