Evaluation of mediVR-KAGURA Guided Therapy

Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562662
• Other study ID #: 202001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: Japan Society of Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Physical Disability

Intervention

Device:
• mediVR KAGURA
Approximately 20 min mediVR KAGURA-guided rehabilitation

Locations

Country	Name	City	State
Japan	Cloud Clinic	Takarazuka	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Japan Society of Clinical Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Primary	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.	baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary	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.	baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary	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.	baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary	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.	baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary	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.	baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention