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

Amputation Clinical Trial

Official title:

Mechanically-induced Stochastic Resonance to Improve Amputee Gait

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985881
• Other study ID #: A4376-R
• Status: Completed
• Phase: N/A
• Start date: April 1, 2007
• Est. completion date: June 25, 2018

Study information

• Verified date: June 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Diabetes Complications

Intervention

Device:
• 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
• Conventional prosthetic socket (current clinical practice)
No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait variability	Self-selected walking speed (mean and standard deviation) in meters/second	Testing with and without stochastic resonance will occur within a single laboratory visit on one day

External Links

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