Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees

The aim of the study is to investigate the influence of a vibro-tactile device on trans-tibial amputees in terms of gait, pain and perception of the prosthesis.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Device: Vibro-tactile Feedback

Detailed Description

The study is divided into three phases. The initial phase lasts 6 to 8 weeks for each subject. For subjects of group 2 the length of the initial phase depends on the progression of the re-innervation. The initial phase ends, when the subject can perceive the tactile stimulate at the re-innervated area of the skin. During the initial phase, all subjects get a new prosthesis. To minimize the adjusting to the new prosthesis only a new socket, which houses the vibro-tactile Feedback system, is fabricated and the old prosthetic food is re-used. After a period of 3 weeks minimum, where the subjects use the new prosthesis, a gait analysis and an assessment of the sensitivity of the skin at the stump are performed.

Subsequently the intervention phase starts and the vibro-tactile feedback system is activated. For a period of 6 months the subjects use the new prostheses with the integrated vibro-tactile feedback system in daily living. After 2 and 4 months, the subjects visit the study site for an assessment of the sensitivity of the skin. After 6 months a second gait analysis and an other assessment of the sensitivity of the skin a the stump are performed. Afterwards the vibro-tactile feedback-system is disabled.

During the observing phase the subjects use the prosthesis with the disabled vibro-tactile feedback system for 4 months.

During all three phases the subjects answer the questionnaires every 2 months.

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Sturma, MSc; Phone Number: 61098 +43140400; Email: agnes.sturma@meduniwien.ac.at
• Study Contact Backup: Name: Oskar Aszmann; Phone Number: 69860 +43140400; Email: oskar.aszmann@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral trans-tibial amputation
• uses a prostheses already for more than 1 year
• sufficient touch sensitivity at the stump
• unimpaired contralateral lower extremity

Exclusion Criteria:

• psychiatric disorder
• cognitive restrictions
• pregnant or breast feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans-tibial Amputees; Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living	Device: Vibro-tactile Feedback; The device measures the force between the prosthetic food and the ground. With this signals, vibratators are triggered. The vibrators are housed by the prosthetic socket and stimulate the stump.
Experimental: Trans-tibial Amputees with TSR; Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living. The subjects underwent a functional nerv-transfer surgery prior to participation, where the proximal part of the sural nerv was to the distal part of the saphenous nerv.	Device: Vibro-tactile Feedback; The device measures the force between the prosthetic food and the ground. With this signals, vibratators are triggered. The vibrators are housed by the prosthetic socket and stimulate the stump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)	The Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) is a multidimensional instrument designed to examine the psychosocial processes involved in adjusting to amputation and a prosthesis. TAPES consists of 9 subscales, with possible scores depending on the single subscale. The range is from 0-12 to 0-25 (depending on the number of items and answer possibilities).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Efficacy Scale International Version (FES-I)	The Fall Efficacy Scale International Version (FES-I) is a questionaire that assesses the fear of falling. Scores can range from 16-64, with a higher score indicating a higher fear of falling.	1 year
Pain Visual analoge scale (VAS)	The pain is measured with a Visual analoge scale form 0 to 10. O indicates no pain, while 10 is the worst pain the person can imagine.	1 year
Number of falls within the last two months	Subjects report the number a falls within the last two months.	1 Year
Gait parameters	Two gait analysis are performed with a 3D video-based marker system. Standard gait parameters (as cardence, speed, step length and weight) as well as kinematic and kinetic parameters are calculated.	6 months
two point discrimination	the two point discrimination (in mm) at the skin of the stump is assessed	6 months
touch perception threshold	the touch percertion at the skin of the stump is assessed with mono filaments	6 months

Collaborators and Investigators

• Sponsor: Agnes Sturma
• Collaborators: University of Applied Sciences Upper Austria
• Investigators: Study Director: Agnes Sturma, MSc, Medical University Vienna

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2238/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
• IPD Sharing Time Frame: upon publication in a scientific journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No