Back to resultsEffectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rTMS and AR
Sham rTMS and AR
AR
Conventional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Repetitive transcranial magnetic stimulation (rTMS), Augmented reality (AR), stroke
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.
Sites / Locations
- Taipei Medical university HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
rTMS and AR group
Sham rTMS and AR group
AR group
Conventional physiotherapy group
Arm Description
Ten 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.
Ten 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.
Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of Berg Balance Scale (BBS)
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Change of Motor evoked potential (MEP)
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Change of Multi-directional Reach Test (MDRT)
Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.
Change of The Postural Assessment Scale for Stroke Patients (PASS)
The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.
Change of Taiwanese Depression Questionnaires (TDQ)
Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". Zero denotes never, three means always. TDQ scores range from 0 to 54.
Full Information
NCT ID
NCT03750526
First Posted
November 20, 2018
Last Updated
January 27, 2023
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03750526
Brief Title
Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
Official Title
Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Repetitive transcranial magnetic stimulation (rTMS), Augmented reality (AR), stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS and AR group
Arm Type
Experimental
Arm Description
Ten 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.
Arm Title
Sham rTMS and AR group
Arm Type
Active Comparator
Arm Description
Ten 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.
Arm Title
AR group
Arm Type
Active Comparator
Arm Description
Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
Arm Title
Conventional physiotherapy group
Arm Type
Active Comparator
Arm Description
Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
Intervention Type
Behavioral
Intervention Name(s)
rTMS and AR
Intervention Description
rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Sham rTMS and AR
Intervention Description
Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
Intervention Type
Behavioral
Intervention Name(s)
AR
Intervention Description
AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Conventional physiotherapy
Intervention Description
Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
Primary Outcome Measure Information:
Title
Change of Time Up Go test (TUG)
Description
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.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Secondary Outcome Measure Information:
Title
Change of Berg Balance Scale (BBS)
Description
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Title
Change of Motor evoked potential (MEP)
Description
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Title
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Description
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Title
Change of Multi-directional Reach Test (MDRT)
Description
Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Title
Change of The Postural Assessment Scale for Stroke Patients (PASS)
Description
The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
Title
Change of Taiwanese Depression Questionnaires (TDQ)
Description
Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". Zero denotes never, three means always. TDQ scores range from 0 to 54.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Hung Lai, MD PhD
Phone
886-2-27372181
Ext
3538
Email
chlai@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, MD PhD
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical university Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, MD PhD
12. IPD Sharing Statement
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Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
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