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

Not Applicable

• Conditions: Stroke
• Interventions: Other: Robot and tDCS on-line; Other: Robot and sham tDCS

• Registration Number: NCT04055597
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-03-01
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot and tDCS on-line	Robot and tDCS on-line	Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
Robot and sham tDCS	Robot and sham tDCS	Combined sham tDCS and upper extremity rehabilitation robot

Primary Outcome Measures

Name	Time	Method
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	Change of Scale for the assessment and rating of ataxia
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	Change of Functional ataxia rating scale - upper limb

Secondary Outcome Measures

Name	Time	Method
Stroke rehabilitation motivation scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Stroke rehabilitation motivation scale
Intrinsic motivation inventory	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Intrinsic motivation inventory
Numeric rating scale for upper extremity pain	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Question about the upper extremity pain (0-10; higher is better)
Functional reaching test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Functional reaching test
modified Barthel index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	modified Barthel index
% maximal voluntary contraction from upper extremity muscles during reaching task	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	data from surface electromyography from upper extremity muscles during reaching task
Kinematic data during scale for the assessment and rating of ataxia	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Kinematic data during 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	Scale for the assessment and rating of ataxia
Functional ataxia rating scale - upper limb	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Functional ataxia rating scale - upper limb, kinematic data during scale for the assessment
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	Kinematic data during scale during the Functional ataxia rating scale - upper limb
Fugl-Meyer Assessment - upper extremity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Fugl-Meyer Assessment - upper extremity
Composite cerebellar functional severity score	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Composite cerebellar functional severity score (Nine hole peg test + click test)
Jerk during reaching and finger pointing	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Kinematic data during reaching and finger pointing using Trakstar
Smoothness during reaching and finger pointing	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Kinematic data during reaching and finger pointing using Trakstar
Behavioral activation system/behavioral inhibition system scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	In terms of motivation
Beck's depression index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline	Beck's depression index

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of