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

NCT05895253 | Terminated

• 1 other identifier: IPS002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lower limb amputation; somatosensory feedback; functional balance; gait performance; rehabilitation; four square step test

Outcome Measures

Primary Outcomes (1)

• Affected leg stance time treatment-change difference

  Stance time of the prosthetic leg during walking over level ground and on a 518 cm instrumented walkway at a self-selected speed

  Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day

Secondary Outcomes (7)

• Gait speed treatment-change difference

  Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day

• Unaffected leg step length treatment-change difference

  Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day

• Quality of life score treatment-change difference

  Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); once each assessment day

• Adverse effects frequency treatment difference

  Difference in the event frequency during the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V - C; once each assessment day

• Timed up and go test time treatment-change difference

  Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day

Study Arms (2)

Control-Vibration

ACTIVE COMPARATOR

Participants were assessed before and after 60 days of no additional intervention to any ongoing treatment, after seven days of washout, and after receiving 60 days of vibrotactile ground-contact feedback.

Device: vibrotactile ground-contact feedback

Vibration-Control

ACTIVE COMPARATOR

Participants were assessed before and after receiving 60 days of vibrotactile ground-contact feedback, after seven days of washout, and after 60 days of no additional intervention to any ongoing treatment.

Device: vibrotactile ground-contact feedback

Interventions

vibrotactile ground-contact feedback DEVICE

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

Control-Vibration; Vibration-Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male, female, and diverse individuals
• unilateral transtibial amputation
• at least 18 months post surgery
• walking without aids possible
• signed informed consent form

You may not qualify if:

• insufficient thigh sensation to distinguish between the two closest vibrotactile actuators
• an acute event that restricts the walking ability
• interfering lesions or painful conditions
• undergone targeted re-innervation surgery
• poor stump condition
• used a non-modular prosthesis
• used a prosthesis in poor condition
• conditions preventing safe participation or interfering with study objectives
• not able to not comply with the protocol

Sponsors & Collaborators

• Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA: lead
• Saphenus Medical Technology GmbH: collaborator

Study Sites (1)

Ordination Dr. Wolfgang Schaden

Vienna, 1030, Austria

Location

Related Publications (1)

• Penasso H, Peternell G, Schultheis R, Pitschl A, Leskovar R, Gardetto A, Ernst J, Schmid-Zalaudek K, Schaden W. Safety and efficacy of vibrotactile feedback for adults with transtibial amputation: A randomized controlled cross-over trial. Clin Biomech (Bristol). 2025 Apr;124:106443. doi: 10.1016/j.clinbiomech.2025.106443. Epub 2025 Feb 10.

  PMID: 40054381 DERIVED

Study Officials

• Gerfried Peternell, MD

  Ludwig Boltzmann Institute for Traumatology, The Research Center in Cooperation with the AUVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 8, 2023
• Study Start: October 25, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: At the time of acceptance in a scientific journal
• Access Criteria: The investigators aim to provide broad, equitable, and maximally open access to the dataset and their metadata free of charge in a timely manner after acceptance, consistent with legal and ethical limits required to maintain privacy and confidentiality, tribal sovereignty, and protection of other sensitive data.

Locations

AU (1)