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

Agnes Sturma

Status: Unknown

Conditions: Amputation

Treatments: Device: Vibro-tactile Feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT03965663

2238/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Trans-tibial Amputees

Experimental group

Description:

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

Treatment:

Device: Vibro-tactile Feedback

Trans-tibial Amputees with TSR

Experimental group

Description:

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.

Treatment:

Device: Vibro-tactile Feedback