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Completed

NCT Number: NCT04562662

Evaluation of mediVR-KAGURA Guided Therapy

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.

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Key information

Conditions

Physical Disability Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

6 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cloud Clinic

Takarazuka, Hyōgo, 6650066, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Inappropriate candidates at attending physician's discretion

Treatment and study plan

mediVR KAGURA

Device

Approximately 20 min mediVR KAGURA-guided rehabilitation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Japan Society of Clinical Research

Other

Registry information

Official study title

Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2020
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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