Clinical trial NCT04562662: Evaluation of mediVR-KAGURA Guided Therapy
Official title: Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Cognitive Dysfunction
Keywords: Virtual Reality
Physical
Cognitive
Lead sponsor: Japan Society of Clinical Research
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Timed up and go test
timeFrame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
measure: Change in Trail Making Test
timeFrame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary outcomes:
measure: Changes in Functional Independence Measure
timeFrame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
measure: Changes in Berg balance scale
timeFrame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
measure: Changes in Mini Mental State Examination
timeFrame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
measure: Changes in Self Rating Depression Scale
timeFrame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Other outcomes:
Locations:
city: Takarazuka
country: Japan
facility: Cloud Clinic
state: Hyogo
Study officials:
affiliation: Cloud Clinic
name: Masahiko Hara, MD, PhD
role: STUDY_CHAIR
References: