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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03965663
• Other study ID #: 2238/2017
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: March 2022

Study information

• Verified date: June 2020
• Source: Medical University of Vienna
• Contact: Agnes Sturma, MSc
• Phone: +43140400
• Email: agnes.sturma[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 13
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Agnes Sturma	University of Applied Sciences Upper Austria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)	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).	1 year
Secondary	Fall Efficacy Scale International Version (FES-I)	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.	1 year
Secondary	Pain Visual analoge scale (VAS)	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.	1 year
Secondary	Number of falls within the last two months	Subjects report the number a falls within the last two months.	1 Year
Secondary	Gait parameters	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.	6 months
Secondary	two point discrimination	the two point discrimination (in mm) at the skin of the stump is assessed	6 months
Secondary	touch perception threshold	the touch percertion at the skin of the stump is assessed with mono filaments	6 months