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

NCT00985881 | Completed

• 1 other identifier: A4376-R
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Diabetes Complications

Keywords

Artificial limbs; Gait; Posture; Prosthesis; Vibration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm 1: stochastic resonance

EXPERIMENTAL

Mechanical stochastic resonance

Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance)

Arm 2: current clinical practice

OTHER

Current clinical practice

Device: Conventional prosthetic socket (current clinical practice)

Interventions

Custom prosthetic socket with mechanical vibrators (stochastic resonance) DEVICE

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

Arm 1: stochastic resonance

Conventional prosthetic socket (current clinical practice) DEVICE

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

Arm 2: current clinical practice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Texas: collaborator

Study Sites (1)

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

Seattle, Washington, 98108, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Glenn K Klute, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: September 29, 2009
• Study Start: April 1, 2007
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)