Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) [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
- Fall Efficacy Scale International Version (FES-I) [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.
- Pain Visual analoge scale (VAS) [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.
- Number of falls within the last two months [1 Year]
Subjects report the number a falls within the last two months.
- Gait parameters [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.
- two point discrimination [6 months]
the two point discrimination (in mm) at the skin of the stump is assessed
- touch perception threshold [6 months]
the touch percertion at the skin of the stump is assessed with mono filaments
Eligibility Criteria
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
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pregnant or breast feeding women
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Agnes Sturma
- University of Applied Sciences Upper Austria
Investigators
- Study Director: Agnes Sturma, MSc, Medical University Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2238/2017