Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation Among Patients With Stroke

Stroke Clinical Trial

Official title:

Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Tremor After Cerebellar and Brainstem Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055597
• Other study ID #: NRC-2017-01-004
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

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

Clinical Trial Summary

Effects of upper extremity rehabilitation robot and transcranial direct current stimulation on upper extremity function among subjects with tremor after stroke

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• 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:

• Stroke with cerebellar hemorrhage or infarction

• ataxia or tremor on upper extremities secondary to stroke

• Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

• History of surgery of affected upper limb

• Fracture of affected upper limb

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Robot and tDCS on-line
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
• Robot and sham tDCS
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 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	Change of Scale for the assessment and rating of ataxia	Change of Scale for the assessment and rating of ataxia	Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline
Primary	Change of Functional ataxia rating scale - upper limb	Change of Functional ataxia rating scale - upper limb	Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline
Secondary	Fugl-Meyer Assessment - upper extremity	Fugl-Meyer Assessment - upper extremity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Composite cerebellar functional severity score	Composite cerebellar functional severity score (Nine hole peg test + click test)	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Jerk during reaching and finger pointing	Kinematic data during reaching and finger pointing using Trakstar	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Smoothness during reaching and finger pointing	Kinematic data during reaching and finger pointing using Trakstar	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Behavioral activation system/behavioral inhibition system scale	In terms of motivation	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Beck's depression index	Beck's depression index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Stroke rehabilitation motivation scale	Stroke rehabilitation motivation scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Intrinsic motivation inventory	Intrinsic motivation inventory	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Numeric rating scale for upper extremity pain	Question about the upper extremity pain (0-10; higher is better)	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Functional reaching test	Functional reaching test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	modified Barthel index	modified Barthel index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	% maximal voluntary contraction from upper extremity muscles during reaching task	data from surface electromyography from upper extremity muscles during reaching task	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Kinematic data during scale for the assessment and rating of ataxia	Kinematic data during scale for the assessment and rating of ataxia	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Scale for the assessment and rating of ataxia	Scale for the assessment and rating of ataxia	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Functional ataxia rating scale - upper limb	Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Kinematic data during scale during the Functional ataxia rating scale - upper limb	Kinematic data during scale during the Functional ataxia rating scale - upper limb	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline