Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke
1 other identifier
interventional
20
1 country
1
Brief Summary
Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedAugust 13, 2019
August 1, 2019
1.7 years
June 18, 2019
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of kinematic data during scale for the assessment and rating of ataxia
kinematic data during scale for the assessment and rating of ataxia using Trakstar (mean velocity, jerk, smoothness)
Change from baseline at 4 weeks after baseline
Secondary Outcomes (5)
kinematic data during scale for the assessment
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Fugl-Meyer Assessment - upper extremity
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Wolf Motor Function Test
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Motor activity log
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Action reach arm test
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Study Arms (2)
Robot and tDCS on-line
EXPERIMENTALCombined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot
Robot and sham tDCS
SHAM COMPARATORCombined sham tDCS and upper extremity rehabilitation robot
Interventions
Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joon-Ho Shin, MS
National Rehabilitation Center
Central Study Contacts
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
August 13, 2019
Study Start
May 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08