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Evaluation of mediVR-KAGURA Guided Therapy

Primary Purpose

Physical Disability, Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
mediVR KAGURA
Sponsored by
Japan Society of Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Disability focused on measuring Virtual Reality, Physical, Cognitive

Eligibility Criteria

6 Years - 110 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cloud Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Single arm (all participants receive interventions)

Outcomes

Primary Outcome Measures

Change in Timed up and go test
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).
Change in Trail Making Test
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

Changes in Functional Independence Measure
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.
Changes in Berg balance scale
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.
Changes in Mini Mental State Examination
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.
Changes in Self Rating Depression Scale
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.

Full Information

First Posted
September 12, 2020
Last Updated
August 14, 2022
Sponsor
Japan Society of Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT04562662
Brief Title
Evaluation of mediVR-KAGURA Guided Therapy
Official Title
Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Japan Society of Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability, Cognitive Dysfunction
Keywords
Virtual Reality, Physical, Cognitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Single arm (all participants receive interventions)
Intervention Type
Device
Intervention Name(s)
mediVR KAGURA
Intervention Description
Approximately 20 min mediVR KAGURA-guided rehabilitation
Primary Outcome Measure Information:
Title
Change in Timed up and go test
Description
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).
Time Frame
baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Title
Change in Trail Making Test
Description
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.
Time Frame
baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary Outcome Measure Information:
Title
Changes in Functional Independence Measure
Description
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.
Time Frame
baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Title
Changes in Berg balance scale
Description
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.
Time Frame
baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Title
Changes in Mini Mental State Examination
Description
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.
Time Frame
baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Title
Changes in Self Rating Depression Scale
Description
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.
Time Frame
baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with physical and/or cognitive dysfunctions 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahiko Hara, MD, PhD
Organizational Affiliation
Cloud Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cloud Clinic
City
Takarazuka
State/Province
Hyogo
ZIP/Postal Code
6650066
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of mediVR-KAGURA Guided Therapy

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