NCT04005131

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

June 18, 2019

Last Update Submit

June 29, 2019

Conditions

Stroke

Keywords

stroketranscranial direct current stimulationupper extremity rehabilitation robot

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • kinematic data during scale for the assessment

    baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Fugl-Meyer Assessment - upper extremity

    baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Wolf Motor Function Test

    baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Motor activity log

    baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

  • Action reach arm test

    baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline

Study Arms (2)

Robot and tDCS on-line

EXPERIMENTAL

Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 10 weeks

Device: Robot and tDCS on-line

Robot and tDCS on-line after sham tDCS

ACTIVE COMPARATOR

Combined sham tDCS and upper extremity rehabilitation robot for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 weeks

Device: Robot and tDCS on-line after sham tDCS

Interventions

Robot and tDCS on-lineDEVICE

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
Robot and tDCS on-line after sham tDCSDEVICE

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

Robot and tDCS on-line after sham tDCS

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe upper extremity pain that could interfere with rehabilitation therapy
  • Neurological disorders other than stroke that can cause motor deficits
  • Uncontrolled severe medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joon-Ho Shin

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin

CONTACT

82-2-901-1884asfreelyas@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant does not know the allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

June 18, 2019

First Posted

July 2, 2019

Study Start

May 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations

KR(1)