Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees

Completed · Not applicable

Conditions studied: Amputation, Diabetes Complications

In brief

The purpose of this study is to determine if subthreshold vibration, when applied to the residual limb of a lower limb amputee through their prosthetic socket, can sufficiently enhance peripheral sensation to result in an improved ability to balance and walk.

Key facts

Study ID

NCT00985881

Run by

VA Office of Research and Development

People needed

17

Starts

2007-04-01

Expected to finish

2018-06-25

Last updated by the study team

2018-06-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Amputee subjects:
• unilateral transtibial amputee of diabetic etiology,
• have been fit with a prosthesis and have used a prosthesis for at least one year,
• wear the prosthesis at least 4 hours per day,
• ambulate without upper extremity aids,
• have no history of injurious falls within the previous six months, and
• touch sensation measured by a 10 gauge Semmes-Weinstein Monofilament in the dermatomes of their residual limb.

You may not qualify if…

• Subjects will be excluded if:
• they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics,
• their residual limb is ulcerated, or
• are currently using anticonvulsant medications for the treatment of neuropathic pain.

Where it is running

• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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