Evaluation of mediVR-KAGURA Guided Therapy

NCT ID: NCT04562662

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-03-31

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.

Conditions

Physical Disability; Cognitive Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Single arm (all participants receive interventions)

Group Type: EXPERIMENTAL

mediVR KAGURA

Intervention Type: DEVICE

Approximately 20 min mediVR KAGURA-guided rehabilitation

Interventions

mediVR KAGURA

Approximately 20 min mediVR KAGURA-guided rehabilitation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Society of Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Masahiko Hara

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masahiko Hara, MD, PhD

Role: STUDY_CHAIR

Cloud Clinic

Locations

Cloud Clinic

Takarazuka, Hyōgo, Japan

Countries

Japan

Other Identifiers

202001

Identifier Type: -

Identifier Source: org_study_id