Virtual Reality Rehabilitation for Individuals With Lower Limb Amputation

Completed · Early Phase 1

Conditions studied: Transtibial Amputation

In brief

A custom designed Virtual Gait Retraining System (VGRS) is being adapted for balance and mobility rehabilitation in individuals with transtibial amputation. The system is composed of a treadmill that can simulate different environmental situations such as walking up stairs and hills and going around curves. The treadmill is synchronized with an immersive display and an avatar of the user. The combination of variable terrain and visual feedback is extremely promising as a means for amputee patients to achieve improved functional mobility after gait training. The proposed work is relevant to public health because it is the first step in developing a novel rehabilitation system that will use visual feedback for gait training in amputees and others with pathological gait disorders. The research is pertinent to the mission of the Department of Veterans Affairs which is committed to improve the quality of life of Veterans with disability.

Key facts

Study ID

NCT02328859

Run by

VA Office of Research and Development

People needed

4

Starts

2016-04-01

Expected to finish

2017-06-27

Last updated by the study team

2019-10-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be unilateral transtibial amputees (TTA) between the ages of 18 and 65 who have consistently used a prosthesis for at least one year.
• Subjects must be community ambulators at a K3 level,
• which dictates that they have the ability or potential to walk with variable cadence,
• to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

You may not qualify if…

• History of surgical procedures on their intact limb.
• Subjects will be excluded from the study if they present with
• cardiovascular,
• neurological,
• or balance disorders that can affect gait.
• Rheumatoid arthritis,
• knee joint replacement,
• and the use of ambulatory aids will also exclude participation.
• Subjects with considerable pain in their knee joints, as measured by a visual analog scale will also be excluded due to the confounding effects of pain on gait patterns.
• A medical history screening will be used to identify subjects with pre-existing conditions that would compromise their gait.

Where it is running

• Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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