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

Primary Purpose

Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Robot and tDCS on-line

Robot and sham tDCS

About this trial

This is an interventional treatment trial for Stroke focused on measuring cerebellar stroke, upper extremity rehabilitation robot, transcranial direct current stimulation, stroke rehabilitation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Robot and tDCS on-line

Robot and sham tDCS

Arm Description

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

Combined sham tDCS and upper extremity rehabilitation robot

Outcomes

Primary Outcome Measures

Change of Scale for the assessment and rating of ataxia

Change of Functional ataxia rating scale - upper limb

Secondary Outcome Measures

Fugl-Meyer Assessment - upper extremity

Composite cerebellar functional severity score

Composite cerebellar functional severity score (Nine hole peg test + click test)

Jerk during reaching and finger pointing

Kinematic data during reaching and finger pointing using Trakstar

Smoothness during reaching and finger pointing

Kinematic data during reaching and finger pointing using Trakstar

Behavioral activation system/behavioral inhibition system scale

In terms of motivation

Beck's depression index

Stroke rehabilitation motivation scale

Intrinsic motivation inventory

Numeric rating scale for upper extremity pain

Question about the upper extremity pain (0-10; higher is better)

Functional reaching test

modified Barthel index

% maximal voluntary contraction from upper extremity muscles during reaching task

data from surface electromyography from upper extremity muscles during reaching task

Kinematic data during scale for the assessment and rating of ataxia

Scale for the assessment and rating of ataxia

Functional ataxia rating scale - upper limb

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

Full Information

NCT ID

NCT04055597

First Posted

March 1, 2018

Last Updated

August 12, 2019

Sponsor

National Rehabilitation Center, Seoul, Korea

1. Study Identification

Unique Protocol Identification Number

NCT04055597

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Rehabilitation Center, Seoul, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

cerebellar stroke, upper extremity rehabilitation robot, transcranial direct current stimulation, stroke rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robot and tDCS on-line

Arm Type

Experimental

Arm Description

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

Arm Title

Robot and sham tDCS

Arm Type

Sham Comparator

Arm Description

Combined sham tDCS and upper extremity rehabilitation robot

Intervention Type

Other

Intervention Name(s)

Robot and tDCS on-line

Intervention Description

Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks

Intervention Type

Other

Intervention Name(s)

Robot and sham tDCS

Intervention Description

Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks

Primary Outcome Measure Information:

Title

Change of Scale for the assessment and rating of ataxia

Description

Change of Scale for the assessment and rating of ataxia

Time Frame

Change of Scale for the assessment and rating of ataxia at 4 weeks after baseline compared to baseline

Title

Change of Functional ataxia rating scale - upper limb

Description

Change of Functional ataxia rating scale - upper limb

Time Frame

Change of the Functional ataxia rating scale - upper limb, at 4 weeks after baseline compared to baseline

Secondary Outcome Measure Information:

Title

Fugl-Meyer Assessment - upper extremity

Description

Fugl-Meyer Assessment - upper extremity

Time Frame