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Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation

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ClinicalTrials.gov Identifier: NCT03750526
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Lai chien hung, Taipei Medical University Hospital

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 22, 2018
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03750526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2018)
  • Change of Berg Balance Scale (BBS) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    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) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    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 [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    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) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    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) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    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) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • Change of Berg Balance Scale (BBS) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    Participants perform a series of 14 functional balance tasks, such as maintaining a quiet stance, sitting-to-stand, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance.
  • Change of Motor evoked potential (MEP) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    MEP is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation of motor cortex.
  • Change of Fugl-Meyer Assessment (FMA) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in persons with stroke.
  • Change of Multi-directional Reach Test (MDRT) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    Participants will be required to reach in the forward, left and right directions
  • Change of The Postural Assessment Scale for Stroke Patients (PASS) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    PASS assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance.
  • Change of Taiwanese Depression Questionnaires (TDQ) [ Time Frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups ]
    TDQ contains 18 items to screen the situation of depression within a week.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation
Official Title  ICMJE Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Behavioral: rTMS and AR
    rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
  • Behavioral: Sham rTMS and AR
    Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
  • Behavioral: AR
    AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
  • Behavioral: Conventional physiotherapy
    Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
Study Arms  ICMJE
  • Experimental: rTMS and AR group
    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.
    Intervention: Behavioral: rTMS and AR
  • Active Comparator: Sham rTMS and AR group
    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.
    Intervention: Behavioral: Sham rTMS and AR
  • Active Comparator: AR group
    Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
    Intervention: Behavioral: AR
  • Active Comparator: Conventional physiotherapy group
    Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
    Intervention: Behavioral: Conventional physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Participants have other neurologic problems that can affect balance and walking ability.
  2. Participants take of drugs or have other medical condition that can affect balance and function.
  3. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chien-Hung Lai, MD PhD 886-2-27372181 ext 3538 chlai@tmu.edu.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03750526
Other Study ID Numbers  ICMJE N201703084
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lai chien hung, Taipei Medical University Hospital
Study Sponsor  ICMJE Taipei Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chien-Hung Lai, MD PhD Taipei Medical University Hospital
PRS Account Taipei Medical University Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP