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

Not Applicable

• Conditions: Amputation
• Interventions: Device: Vibro-tactile Feedback

• Registration Number: NCT03965663
• Lead Sponsor: Agnes Sturma

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.

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 Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Study Start: 2020-07
• Last Update Posted: 2020-07-01
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-tibial Amputees with TSR	Vibro-tactile Feedback	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.
Trans-tibial Amputees	Vibro-tactile Feedback	Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Number of falls within the last two months	1 Year	Subjects report the number a falls within the last two months.
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.
two point discrimination	6 months	the two point discrimination (in mm) at the skin of the stump is assessed
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.
touch perception threshold	6 months	the touch percertion at the skin of the stump is assessed with mono filaments