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Vibrotactile Stimulation With Saphenus Device

NCT05961072 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-27

No results posted yet for this study

Summary

To determine the benefit of the vvibrotactile sensory feedback device.

Conditions

  • Amputation

Interventions

DEVICE

Vibrotactile sensory feedback 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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Kyle R Eberlin, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-12-01
Completion
2024-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961072 on ClinicalTrials.gov