Clinical trial NCT05961072: Vibrotactile Stimulation With Saphenus Device
Official title: Vibrotactile Stimulation for Improved Gait and Pain After Major Lower Extremity Amputation Using a Non-invasive Vibration Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amputation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Major lower limb amputee
* Willing and able to participate

Exclusion Criteria:

* Age under 18

Primary outcomes:
measure: Measure Velocity
timeFrame: One Year
measure: Measure Endurance
timeFrame: One Year
measure: Measure Physical Function
timeFrame: One Year
measure: Measure User Satisfaction of Function
timeFrame: One Year
measure: Measure Pain Overall
timeFrame: One Year
measure: Measure Pain Interference
timeFrame: One Year
measure: Measure Pain Intensity
timeFrame: One Year
Secondary outcomes:
measure: Measure Patient Satisfaction
timeFrame: One Year
measure: Measure Patient Depression
timeFrame: One Year
measure: Measure Patient Anxiety
timeFrame: One Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kyle R Eberlin, MD
role: PRINCIPAL_INVESTIGATOR
References: