NCT04055597

Brief Summary

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

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
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable stroke

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

June 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
5 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

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

March 1, 2018

Last Update Submit

August 12, 2019

Conditions

Stroke

Keywords

cerebellar strokeupper extremity rehabilitation robottranscranial direct current stimulationstroke rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • Fugl-Meyer Assessment - upper extremity

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Composite cerebellar functional severity score

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Jerk during reaching and finger pointing

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Smoothness during reaching and finger pointing

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • Behavioral activation system/behavioral inhibition system scale

    baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  • +11 more secondary outcomes

Study Arms (2)

Robot and tDCS on-line

EXPERIMENTAL

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

Other: Robot and tDCS on-line

Robot and sham tDCS

SHAM COMPARATOR

Combined sham tDCS and upper extremity rehabilitation robot

Other: Robot and sham tDCS

Interventions

Robot and tDCS on-lineOTHER

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

Robot and tDCS on-line
Robot and sham tDCSOTHER

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

Robot and sham tDCS

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • History of surgery of affected upper limb
  • Fracture of affected upper limb

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, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

March 1, 2018

First Posted

August 14, 2019

Study Start

June 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

KR(1)