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Clinical Trials/NCT03750526
NCT03750526
Recruiting
Not Applicable

Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke

Taipei Medical University Hospital1 site in 1 country40 target enrollmentJuly 31, 2018
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Taipei Medical University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Change of Time Up Go test (TUG)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).

Detailed Description

Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.

Registry
clinicaltrials.gov
Start Date
July 31, 2018
End Date
December 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lai chien hung

Professor

Taipei Medical University Hospital

Eligibility Criteria

Inclusion Criteria

  • Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
  • Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
  • Participants are stable in medical and psychological condition.

Exclusion Criteria

  • Participants have other neurologic problems that can affect balance and walking ability.
  • Participants take of drugs or have other medical condition that can affect balance and function.
  • Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.

Outcomes

Primary Outcomes

Change of Time Up Go test (TUG)

Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups

The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.

Secondary Outcomes

  • Change of Berg Balance Scale (BBS)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
  • Change of Motor evoked potential (MEP)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
  • Change of Fugl-Meyer Assessment (FMA)-Lower extremity(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
  • Change of Multi-directional Reach Test (MDRT)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
  • Change of The Postural Assessment Scale for Stroke Patients (PASS)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
  • Change of Taiwanese Depression Questionnaires (TDQ)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)

Study Sites (1)

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