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Evaluation of mediVR-KAGURA Guided Therapy

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ClinicalTrials.gov Identifier: NCT04562662
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Masahiko Hara, Japan Society of Clinical Research

Brief Summary:
The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.

Condition or disease Intervention/treatment Phase
Physical Disability Cognitive Dysfunction Device: mediVR KAGURA Not Applicable

Detailed Description:

The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld controllers in a motion-tracked three-dimensional space called "room scale" of the mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users with >90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology.

First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. Horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 * maximum reaching distance, 0.9 * (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. A falling object disappeared at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. By thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training.

The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation programs will be personalized.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Intervention group
Single arm (all participants receive interventions)
Device: mediVR KAGURA
Approximately 20 min mediVR KAGURA-guided rehabilitation




Primary Outcome Measures :
  1. Change in Timed up and go test [ Time Frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention ]
    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. Shorter score means a better outcome. The minimum value could be 5 seconds or less, and the maximum value could be infinity (cannot complete the test).

  2. Change in Trail Making Test [ Time Frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention ]
    The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. Shorter score means a better outcome. The minimum value could be 15 seconds or less, and the maximum value could be infinity or be defined as 300 seconds when patients cannot complete the test.


Secondary Outcome Measures :
  1. Changes in Functional Independence Measure [ Time Frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention ]
    The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients throughout the rehabilitation process following a stroke, traumatic brain injury, spinal cord injury or cancer. Higher score means a better outcome. The minimum value is 18, and the maximum value is 126.

  2. Changes in Berg balance scale [ Time Frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention ]
    The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities. Higher score means a better outcome. The minimum value is 0, and the maximum value is 56.

  3. Changes in Mini Mental State Examination [ Time Frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention ]
    The Mini-Mental State Examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher score means a better outcome. The minimum value is 0, and the maximum value is 30.

  4. Changes in Self Rating Depression Scale [ Time Frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention ]
    The Self Rating Depression Scale (SDS) is a psychiatric measuring instrument having descriptive words and phrases that indicate the severity of depression for a time period. Lower score means a better outcome. The minimum value is 20, and the maximum value is 80.



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Ages Eligible for Study:   6 Years to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with physical and/or cognitive dysfunctions
  2. Agreed to the participation of this study with written informed consent by themselves or guardians

Exclusion Criteria:

1. Inappropriate candidates at attending physician's discretion


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562662


Contacts
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Contact: Masahiko Hara, MD, PhD 81-798-31-7588 hara@japanscr.org

Locations
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Japan
Cloud Clinic Recruiting
Takarazuka, Hyogo, Japan, 6650066
Contact: Masahiko Hara, MD, PhD    81-798-31-7588    hara@japanscr.org   
Sponsors and Collaborators
Japan Society of Clinical Research
Investigators
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Study Chair: Masahiko Hara, MD, PhD Cloud Clinic
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Responsible Party: Masahiko Hara, Principal Investigator, Japan Society of Clinical Research
ClinicalTrials.gov Identifier: NCT04562662    
Other Study ID Numbers: 202001
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masahiko Hara, Japan Society of Clinical Research:
Virtual Reality
Physical
Cognitive
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders