Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
1 other identifier
interventional
13
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedJuly 1, 2020
June 1, 2020
1.4 years
May 24, 2019
June 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Fall Efficacy Scale International Version (FES-I)
1 year
Pain Visual analoge scale (VAS)
1 year
Number of falls within the last two months
1 Year
Gait parameters
6 months
two point discrimination
6 months
- +1 more secondary outcomes
Study Arms (2)
Trans-tibial Amputees
EXPERIMENTALUnilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living
Trans-tibial Amputees with TSR
EXPERIMENTALUnilateral 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- unilateral trans-tibial amputation
- uses a prostheses already for more than 1 year
- sufficient touch sensitivity at the stump
- unimpaired contralateral lower extremity
You may not qualify if:
- psychiatric disorder
- cognitive restrictions
- pregnant or breast feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agnes Sturmalead
- University of Applied Sciences Upper Austriacollaborator
Study Officials
- STUDY DIRECTOR
Agnes Sturma, MSc
Medical University Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physical Therapist, Research Fellow
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 29, 2019
Study Start
July 1, 2020
Primary Completion
December 1, 2021
Study Completion
March 1, 2022
Last Updated
July 1, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- upon publication in a scientific journal
All IPD from the mentioned outcome parameters are planned to be made available to other researchers.