Long-term effectiveness of a prosthetic walking program in combination with Virtual Reality

UMIN ID: UMIN000055986

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult men and women aged 18 and over enrolled at Hiroshima University
• Date of first enrollment: 2024/10/30
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The VR video viewing group wears a simulated prosthetic leg and performs in-situ stepping movements on the parallel bars for five minutes each time, twice a week for four weeks. The participants are asked to perform the stepping movements in accordance with the gait in the VR video, while viewing the images taken subjectively of walking with a prosthetic leg in the VR space.
The control group wears a simulated prosthetic leg and performs in-situ stepping movements in the parallel bars for five minutes each time, twice a week for four weeks. The control group, unlike the VR video viewing group, does not watch the video.

Outcome(s)

• Primary Outcome: 10 m walking time Both pre- and post-measurements (four weeks after the pre-measurement) are carried out three times each and the average of the three measurements is calculated. During walking, an assistant is attached to the side of the simulated prosthesis to ensure safety with light assistance.
• Secondary Outcome: Body centre of gravity acceleration during 10 m walking time measurement. Timed up and go test Measurement of centre-of-gravity sway Degree of immersion

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: (i) Persons who are in a vulnerable position as a research subject because the principal investigator or research assistant and the research subject are in a teacher-student relationship and the student is attending a lecture given by the research officer (ii) Persons who are prone to VIMS (iii) Other persons deemed inappropriate by the person in charge of the research.

Related Information

• Primary Sponsor: Hiroshima University
• Source(s) of Monetary Support: None