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Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation

NCT05895253 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-06-13

No results posted yet for this study

Summary

Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Saphenus has developed a feedback system called Suralis© that transfers pressure signals from the prosthetic sole to another body region. This clinical investigation aimed to determine if this system improves gait stability and walking. The study analyzed changes in gait and functional balance and gathered patient-reported measures to evaluate the quality of life.

This research was open to individuals who have undergone below-knee amputation but no targeted re-innervation surgery and use prosthetics. Participants received the Suralis© feedback system, and the investigators assessed their walking activities. The system measures prosthetic foot sole pressure and converts it into digital signals, triggering vibration stimuli during the stance phase of walking. The investigators collected gait analyses and patient feedback to assess the impact of the feedback system on prosthetic management. The results will help us understand the benefits and effectiveness of this technology for people with amputation.

Conditions

  • Amputation of Lower Limb Below Knee
  • Unilateral

Interventions

DEVICE

vibrotactile ground-contact feedback

Suralis®, Saphenus Medical Technology (Baden, Lower Austria, Austria)

Sponsors & Collaborators

  • Saphenus Medical Technology GmbH

    collaborator INDUSTRY

  • Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

    lead OTHER_GOV

Principal Investigators

  • Gerfried Peternell, MD · Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with the AUVA

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2022-05-06
Completion
2022-05-06

Countries

  • Austria

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 NCT05895253 on ClinicalTrials.gov