AmputationNCT00985881
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
A study testing Custom prosthetic socket with mechanical vibrators (stochastic resonance) and Conventional prosthetic socket (current clinical practice) in people with Amputation and Diabetes Complications, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation, Diabetes Complications
- What is being tested?
- Custom prosthetic socket with mechanical vibrators (stochastic resonance) and Conventional prosthetic socket (current clinical practice)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2007to 25 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Mechanically-induced Stochastic Resonance to Improve Amputee Gait
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.
Read the 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
- Being tested
- Custom prosthetic socket with mechanical vibrators (stochastic resonance), Conventional prosthetic socket (current clinical practice)
- Keywords
- Artificial limbs, Gait, Posture, Prosthesis, Vibration
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Conventional prosthetic socket (current clinical practice)Device
No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: stochastic resonance | Experimental | Mechanical stochastic resonance Receives: Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance) |
| Arm 2: current clinical practice | Other | Current clinical practice Receives: Device: Conventional prosthetic socket (current clinical practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait variability
Self-selected walking speed (mean and standard deviation) in meters/second
Measured: Testing with and without stochastic resonance will occur within a single laboratory visit on one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study start1 Apr 2007
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Glenn K Klute, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985881
- Sponsor's protocol ID
- A4376-R
- Status last verified
- Jun 2018
- First submitted
- 25 Mar 2008
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanically-induced Stochastic Resonance to Improve Amputee Gait
- ClinicalTrials.gov ID
- NCT00985881
- Acronym / sponsor ID
- A4376-R
- Conditions
- Amputation, Diabetes Complications
- Keywords
- Artificial limbs, Gait, Posture, Prosthesis, Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Texas
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 29 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: stochastic resonance | Experimental | Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance)Mechanical stochastic resonance |
| Arm 2: current clinical practice | Other | Device: Conventional prosthetic socket (current clinical practice)Current clinical practice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Arm 1: stochastic resonance |
| Conventional prosthetic socket (current clinical practice)No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket. | Device | Arm 2: current clinical practice |
Primary outcome
Gait variability
Time frame: Testing with and without stochastic resonance will occur within a single laboratory visit on one day
Self-selected walking speed (mean and standard deviation) in meters/second
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Click here for more information about this study: Mechanically-induced Stochastic Resonance to Improve Amputee GaitLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn K Klute, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom prosthetic socket with mechanical vibrators (stochastic resonance) and Conventional prosthetic socket (current clinical practice) in people with Amputation and Diabetes Complications, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait variability (time frame: Testing with and without stochastic resonance will occur within a single laboratory visit on one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.