Descriptive Study of Receptive Fields in Lower Limb Amputees

Not Applicable

• Conditions: Lower Limb Amputation Below Knee (Injury)
• Interventions: Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany

• Registration Number: NCT03348605
• Lead Sponsor: Rehaklinik Bellikon

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-27
• Study First Submitted: 2017-10-30
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-21
• Last Update Posted: 2017-11-21
• Primary Completion: 2018-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First setting ON	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 ON. The second time the gait analysis is performed in the OFF modality.
First setting OFF	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.

Primary Outcome Measures

Name	Time	Method
Description of receptive Fields Size in cm2	4-5 Weeks (7 hours)	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.
Description of receptive Fields Position in % overlapping from first measurement	4-5 Weeks (7 hours)	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.

Secondary Outcome Measures

Name	Time	Method
Change in gait parameters through Phantom Stimulator	1/2 Day (3 hours)	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).
Change in phantom sensations through Phantom Stimulator	1/2 Day (3 hours)	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).

Trial Locations

Locations (1)

Rehaklinik Bellikon; 🇨🇭 Bellikon, Aargau, Switzerland