Amputation Clinical Trial
Official title:
Vibro-tactile Pressure Feedback of the Prosthetic Foot for Trans-tibial Amputees
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.
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.
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