Vibrotactile Stimulation With Saphenus Device

NCT05961072 | Unknown FDA Device

• 1 other identifier: 2023P001047
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the benefit of the vvibrotactile sensory feedback device.

Conditions

Amputation

Outcome Measures

Primary Outcomes (7)

• Measure Velocity

  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).

  One Year

• Measure Endurance

  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).

  One Year

• Measure Physical Function

  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.

  One Year

• Measure User Satisfaction of Function

  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.

  One Year

• Measure Pain Overall

  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).

  One Year

• Measure Pain Interference

  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.

  One Year

• Measure Pain Intensity

  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.

  One Year

Secondary Outcomes (3)

• Measure Patient Satisfaction

  One Year

• Measure Patient Depression

  One Year

• Measure Patient Anxiety

  One Year

Study Arms (1)

Patients receiving the vibrotactile sensory feedback device

EXPERIMENTAL

Patients who have undergone a major lower limb amputation and are receiving the vibrotactile sensory feedback device

Device: Vibrotactile sensory feedback device

Interventions

Vibrotactile sensory feedback device DEVICE

The company Saphenus Medical Technology GmbH will provide all of the devices for this study. The non-invasive vibrotactile sensory feedback device consists of 4 vibration -motors, which are placed in a cuff or pant on the patient's residual limb (RL). Furthermore, the system consists of a foot sole with integrated sensors and transmitters. The patient will put the sole of their foot into the shoe of the amputated side. There are 4 sensors matching the vibration motors - 3 under the forefoot and 1 on the heel - in the foot sole. Depending on whether the patient loads their forefoot or their heel while walking, the assigned vibration motor vibrates on the skin of their RL. The patient will learn which vibration motor is assigned to their forefoot and which to their heel. This gives the patient sensory feedback without having to check with their eyes which part of the prosthetic foot is currently touching the ground.

Patients receiving the vibrotactile sensory feedback device

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Age under 18

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Kyle R Eberlin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle R Eberlin, MD

CONTACT

(617) 643-4902; keberlin@mgh.harvard.edu

Karan Amin, BA

CONTACT

5165288329; kamin2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)