Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965663
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
University of Applied Sciences Upper Austria
Information provided by (Responsible Party):
Agnes Sturma, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Amputation Device: Vibro-tactile Feedback Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Fall Efficacy Scale International Version (FES-I) [ Time Frame: 1 year ]
    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.

  2. Pain Visual analoge scale (VAS) [ Time Frame: 1 year ]
    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.

  3. Number of falls within the last two months [ Time Frame: 1 Year ]
    Subjects report the number a falls within the last two months.

  4. Gait parameters [ Time Frame: 6 months ]
    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.

  5. two point discrimination [ Time Frame: 6 months ]
    the two point discrimination (in mm) at the skin of the stump is assessed

  6. touch perception threshold [ Time Frame: 6 months ]
    the touch percertion at the skin of the stump is assessed with mono filaments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965663


Contacts
Layout table for location contacts
Contact: Agnes Sturma, MSc +43140400 ext 61098 agnes.sturma@meduniwien.ac.at
Contact: Oskar Aszmann +43140400 ext 69860 oskar.aszmann@meduniwien.ac.at

Sponsors and Collaborators
Agnes Sturma
University of Applied Sciences Upper Austria
Investigators
Layout table for investigator information
Study Director: Agnes Sturma, MSc Medical University Vienna
Layout table for additonal information
Responsible Party: Agnes Sturma, Physical Therapist, Research Fellow, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03965663    
Other Study ID Numbers: 2238/2017
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
Time Frame: upon publication in a scientific journal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No