Vibrotactile Stimulation for Improved Gait and Pain After Major Lower Extremity Amputation Using a Non-invasive Vibration Device
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Measure Velocity
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To determine the benefit of the vvibrotactile sensory feedback device.
Detailed Description
In the United States, approximately 150.000 patients undergo a lower extremity amputation annually. With a high change of developing neuropathic pain, decreased mobility due to the missing limb and therefore depressed mental wellbeing, lower extremity amputations are debilitating the patient on multiple facets. From the usage of non-mechanical prosthetic wear, meaningful improvements have been made in surgical amputee care in the recent decades. Osseointegration, and later regenerative nerve surgical techniques like targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) have led to major improvements in the mobility of lower limb amputees, by introducing myoeletric prosthetics. Although technological advances have let to improved motoric function and motor control over artificial limbs, sensory feedback is still a very complex aspect of regaining full control over the missing limb. Recently, introduced as a technical variation on TMR, Targeted Sensory Reinnervation is based on reinnervation of a defined skin area by another sensory nerve. Recently, application of vibrotactile feedback, connected to the lower extremity prosthetic socket, has shown promising results in regaining proprioception in the missing limb, resulting in improved walking ability and pain. However, Targeted Sensory Reinnervation (TSR) is a novel surgical technique which is not always possible to perform and not available to every lower extremity amputee. Therefore, this study aims to investigate whether this vibrotactile sensory feedback device improves gait and pain in major lower limb amputee population regardless of whether TSR has been conducted.
Investigators
Kyle R. Eberlin, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •English-speaking
- •Major lower limb amputee
- •Willing and able to participate
Exclusion Criteria
- •Age under 18
Outcomes
Primary Outcomes
Measure Velocity
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on gait velocity by asking the participant to walk a given distance during gait tests and measuring the velocity during which they walk during this distance. The specific gait test is the 10-meter gait velocity test (meters/second).
Measure User Satisfaction of Function
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on physical function of the patient through the Orthotics Prosthetics Users Survey satisfaction with device questionnaire after the gait tests. This scale goes from 20-100 where lower numbers indicate easier ability to perform physical activities.
Measure Pain Overall
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as the Defense and Veterans Pain Rating Scale (DVPRS). This scale goes from 0 (no pain) to a 10 (as bad as it could be, nothing else matters).
Measure Pain Interference
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as Patient Reported Outcome Measurements Pain Interference Short Form 4a. This scale goes from 4-20 where lower numbers indicate less pain.
Measure Pain Intensity
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on amputation-related pain through patient-reported outcomes such as Patient Reported Outcome Measurements Pain Intensity Short Form 3a. This scale goes from 3-15 where lower numbers indicate less pain.
Measure Endurance
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on endurance by asking the participant to walk a given distance during the 2 minute walking endurance test (meters).
Measure Physical Function
Time Frame: One Year
To investigate the potential effects of vibrotactile stimulation on physical function of the patient through the Patient Reported Outcome Measurements Physical function short form 6b. This scale goes from 6-30 where lower numbers mean that the patient is less physically able.
Secondary Outcomes
- Measure Patient Depression(One Year)
- Measure Patient Anxiety(One Year)
- Measure Patient Satisfaction(One Year)