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

NCT ID: NCT00985881

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-01
• Study Completion Date: 2018-06-25

Brief Summary

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.

Detailed Description

One of the many complications of diabetes is the loss of sensation in the feet. This sensory deficit can negatively impact the postural stability and mobility of non-amputees, since without feedback, it is simply more difficult to stand and walk. For lower limb amputees, the problem is compounded. These patients often have difficulty with prosthetic limb placement during maneuvering tasks, exhibit dramatic increases in the movement of their center of pressure during quiet standing, and both clinical and observational gait analysis reveal significant changes in their gait pattern relative to non-amputees.

The investigators' work proposes to explore the use of a novel prosthetic intervention for diabetic lower limb amputees. The investigators hypothesize that the intervention will sufficiently enhance proprioception to result in measurably improved postural stability and locomotor function for these patients. The intervention is based on a phenomenon known as stochastic resonance, whereby the application of sub-threshold vibration enables mechano-receptors previously unable to respond to stimuli to become more susceptible to depolarization. For Veterans with neuropathic proprioceptive losses, stochastic resonance may facilitate a functional response from subtle stimuli where gross inputs were formerly required.

Conditions

Amputation; Diabetes Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1: stochastic resonance

Mechanical stochastic resonance

Group Type: EXPERIMENTAL

Custom prosthetic socket with mechanical vibrators (stochastic resonance)

Intervention Type: DEVICE

Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system

Arm 2: current clinical practice

Current clinical practice

Group Type: OTHER

Conventional prosthetic socket (current clinical practice)

Intervention Type: DEVICE

No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.

Interventions

Custom prosthetic socket with mechanical vibrators (stochastic resonance)

Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system

Intervention Type: DEVICE

Conventional prosthetic socket (current clinical practice)

No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn K Klute, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Countries

United States

Related Links

http://www.amputation.research.va.gov/

Click here for more information about this study: Mechanically-induced Stochastic Resonance to Improve Amputee Gait

Other Identifiers

A4376-R

Identifier Type: -

Identifier Source: org_study_id