Evaluation of mediVR-KAGURA Guided Therapy

NCT04562662 | Completed

• 1 other identifier: 202001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability; Cognitive Dysfunction

Keywords

Virtual Reality; Physical; Cognitive

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Changes in Functional Independence Measure

  baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

• Changes in Berg balance scale

  baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

• Changes in Mini Mental State Examination

  baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

• Changes in Self Rating Depression Scale

  baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention

Study Arms (1)

Intervention group

EXPERIMENTAL

Single arm (all participants receive interventions)

Device: mediVR KAGURA

Interventions

mediVR KAGURA DEVICE

Approximately 20 min mediVR KAGURA-guided rehabilitation

Intervention group

Eligibility Criteria

• Age: 6 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with physical and/or cognitive dysfunctions
• Agreed to the participation of this study with written informed consent by themselves or guardians

You may not qualify if:

• \. Inappropriate candidates at attending physician's discretion

Sponsors & Collaborators

• Japan Society of Clinical Research: lead

Study Sites (1)

Cloud Clinic

Takarazuka, Hyōgo, 6650066, Japan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Masahiko Hara, MD, PhD

  Cloud Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 24, 2020
• Study Start: September 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)