Clinical trial NCT03965663: Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
Official title: Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences Upper Austria
First posted: 2019-05-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)
timeFrame: 1 year
Secondary outcomes:
measure: Fall Efficacy Scale International Version (FES-I)
timeFrame: 1 year
measure: Pain Visual analoge scale (VAS)
timeFrame: 1 year
measure: Number of falls within the last two months
timeFrame: 1 Year
measure: Gait parameters
timeFrame: 6 months
measure: two point discrimination
timeFrame: 6 months
measure: touch perception threshold
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Medical University Vienna
name: Agnes Sturma, MSc
role: STUDY_DIRECTOR
References: