An interventional study of Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany in Lower Limb Amputation Below Knee (Injury), sponsored by Rehaklinik Bellikon. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Rehaklinik Bellikon · Not applicable, Interventional, and Screening
It has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically.
This clinical trial aims to investigate the reliability in detecting these receptive fields as well as their incidence and changes over time.
Further it aims to evaluate the acute effect of a stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)) on selected gait parameters measured tough a gait analysis system ("OprtoGait" (Microgate, Bolzano, Italy)) as well as on phantom sensations measured through a questionnaire.
It has been observed that patients subjected to amputations develop so called receptive fields, which time of occurrence and localization over time are yet not examined systematically.
A receptive field is defined as skin area anywhere on the same side of the body as the amputation, which when stimulated by others, causes phantom sensations in the amputated extremity.
This clinical trial aims to investigate the reliability in detecting these receptive fields as well as their incidence and changes over time.
Further it aims to evaluate the acute effect of the stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)) on selected gait parameters measured tough a gait analysis system ("OprtoGait" (Microgate, Bolzano, Italy)) as well as on phantom sensations measured through a questionnaire.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 35 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →This is the only study on the registry with Rehaklinik Bellikon as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for descriptive study:
a. Lower limb amputation (independently of side or height of amputation)
Inclusion criteria for Phantom stimulator:
Exclusion criteria:
This arm performs the Gait analysis the first time after the familiarization phase with the stimulator in the modality ON. The second time the gait analysis is performed in the OFF modality.
Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany
This arm performs the Gait analysis the first time after the familiarization phase with the stimulator in the modality OFF. The second time the gait analysis is performed in the ON modality.
Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany
This system consists of a pressure sensing insole connected to regular TENS-Electrode patches which are applied to the receptive fields of the patients (evoking the sensation of heel and forefoot). The individually adjusted stimulation intensity on the systems regulatory box through a socked screw is set at the beginning of the testing phase, and not changed anymore. The current is applied to mimic the roll-off-sensation while walking. This is done by locating two sets of electrodes on the receptive fields representing the heel and the ball of the foot respectively. Now the current is applied in an alternating manner coordinated with the walking of the participant. The coordination is made able through the pressure sensing insole.
Description of receptive Fields Size in cm2
The primary outcomes are the changes in size over time. Here the size is described in cm2. The Fields size will be recorded by drawing them on the skin with eyeliner and subsequently taking photos. Later, these photos are analysed with the computer program Photoshop.
Time frame: 4-5 Weeks (7 hours)
Description of receptive Fields Position in % overlapping from first measurement
The primary outcomes are the changes in Position over time. Here the position is described in % overlapping with respect to the first measurement. The Fields position will be recorded by drawing them on the skin with eyeliner and subsequently taking photos. Later, these photos are put together and compared with the computer program Photoshop.
Time frame: 4-5 Weeks (7 hours)
Change in gait parameters through Phantom Stimulator
The secondary outcomes are the change in selected gait parameters through the application of the stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)). These parameters are measured with the gait analysis system Optogait. The selected parameters are step length (cm), width (cm), cadence (steps/min) and speed (m/s).
Time frame: 1/2 Day (3 hours)
Change in phantom sensations through Phantom Stimulator
The secondary outcomes are the change in phantom sensations through the application of the stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)). These changes are measured through a questionnaire witch uses the Visual Analogue Scale (values from 1 - 10).
Time frame: 1/2 Day (3 hours)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD is used only internally the study concerning the Phantom Stimulator (Cort X Sensorics, Spaichingen Germany). The IPD is shared with the responsible investigative parties of the Rehaklinik Bellikon only. It will be available to the participant after completion of the study. The data obtained from the Study results in a publication after completion of the study.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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