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

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

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

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Robot and tDCS on-line; Other: Robot and sham tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • Recruiting
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot and tDCS on-line; Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot	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
Sham Comparator: Robot and sham tDCS; Combined sham tDCS and upper extremity rehabilitation robot	Other: Robot and sham tDCS; Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment - upper extremity	Fugl-Meyer Assessment - upper extremity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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
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
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
Behavioral activation system/behavioral inhibition system scale	In terms of motivation	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Beck's depression index	Beck's depression index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale	Stroke rehabilitation motivation scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory	Intrinsic motivation inventory	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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
Functional reaching test	Functional reaching test	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
modified Barthel index	modified Barthel index	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
% 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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; stroke rehabilitation; upper extremity rehabilitation robot; cerebellar stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NRC-2017-01-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No