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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amputation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trans-tibial Amputees

Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living

Group Type EXPERIMENTAL

Vibro-tactile Feedback

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Vibro-tactile Feedback

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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