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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005131
• Other study ID #: NRC-2018-01-003
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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