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

Sponsor
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA (Other)
Overall Status
Terminated
CT.gov ID
NCT05895253
Collaborator
Saphenus Medical Technology GmbH (Industry)
18
1
2
6.3
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: vibrotactile ground-contact feedback
N/A

Detailed Description

The investigators conducted a prospective, unblinded crossover trial to compare the effectiveness of a vibration intervention with no intervention. Participants were randomly assigned to one of two sequences: vibration intervention followed by no intervention or vice versa. The intervention involved using the Suralis© vibrotactile ground-contact feedback system for 60 days. The system transmitted ground contact information to the residual lateral thigh, providing sensory feedback. During the control phase, participants received no additional intervention. The washout period lasted seven days. The study collected data during four visits, assessing gait and patient-reported measures. Bayesian generalized linear mixed models were used for data analysis, considering fixed effects (intervention, sequence, and period) and random effects (individuality).

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Safety and Efficacy of Vibro-tactile Feedback for Patients Who Underwent Lower Limb Amputation
Actual Study Start Date :
Oct 25, 2021
Actual Primary Completion Date :
May 6, 2022
Actual Study Completion Date :
May 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control-Vibration

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

Active Comparator: Vibration-Control

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

Outcome Measures

Primary Outcome Measures

  1. Affected leg stance 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]

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

Secondary Outcome Measures

  1. 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]

    Average speed of walking over level ground and on a 518 cm instrumented walkway at a self-selected speed

  2. 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]

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

  3. 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]

    EuroQol (EQ) 5-Dimension (5D) 3-Level (3L) version, visual analog scale (VAS)

  4. 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]

    Patient diary documentation and interview regarding adverse effects

  5. 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]

    Stand up, walk 3 m, turn around, and sit down

  6. 2 min walk test distance 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]

    Walking distance in meters within a 2 min time frame

  7. Four square step 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]

    Do and reverse four steps over 90 cm long canes arranged in a cross configuration on the ground

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • male, female, and diverse individuals

  • unilateral transtibial amputation

  • at least 18 months post surgery

  • walking without aids possible

  • signed informed consent form

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ordination Dr. Wolfgang Schaden Vienna Austria 1030

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
ClinicalTrials.gov Identifier:
NCT05895253
Other Study ID Numbers:
  • IPS002
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA

Study Results

No Results Posted as of Jun 13, 2023