An interventional study of Vibro-tactile Feedback in Amputation, sponsored by Agnes Sturma. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by Agnes Sturma · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Agnes Sturma as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Unilateral Trans-tibial Amputees that use vibro-tactile feedback for six months in daily living
Device: Vibro-tactile Feedback
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.
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.
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).
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Number of falls within the last two months
Subjects report the number a falls within the last two months.
Time frame: 1 Year
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.
Time frame: 6 months
two point discrimination
the two point discrimination (in mm) at the skin of the stump is assessed
Time frame: 6 months
touch perception threshold
the touch percertion at the skin of the stump is assessed with mono filaments
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Yes — All IPD from the mentioned outcome parameters are planned to be made available to other researchers.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.