Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jul 2018
Longer than P75 for not_applicable stroke
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
July 31, 2018
CompletedFirst Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJanuary 31, 2023
January 1, 2023
5.3 years
November 20, 2018
January 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Time Up Go test (TUG)
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.
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
rTMS and AR group
EXPERIMENTALTen participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
Sham rTMS and AR group
ACTIVE COMPARATORTen participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
AR group
ACTIVE COMPARATORTen participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
Conventional physiotherapy group
ACTIVE COMPARATORTen participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
Interventions
rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical university Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chien-Hung Lai, MD PhD
Taipei Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 23, 2018
Study Start
July 31, 2018
Primary Completion
October 30, 2023
Study Completion
December 30, 2023
Last Updated
January 31, 2023
Record last verified: 2023-01