NCT03965663

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Agnes Sturma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2019-05-29
• Last updated: 2020-07-01