Clinical trial NCT03348605: Descriptive Study of Receptive Fields in Lower Limb Amputees
Official title: Descriptive Study of Receptive Fields in Lower Limb Amputees and the Effect of a Related Stimulation System on Selected Gait Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury)
Keywords: Amputation
Phantom Pain
Gait analysis
Lead sponsor: Rehaklinik Bellikon
Sponsor class: OTHER
Collaborators: name: Cort X Sensorics GmbH
First posted: 2017-11-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The primary outcomes are the changes in size and position over time and their timed occurrence after the amputation of these receptive fields as well as the inter-/intratester reliability in their detection.

The secondary outcomes are the change in selected gait parameters and phantom sensations through the application of the stimulating system ("Phantom Stimulator" (Cort X Sensorics, Spaichingen, Germany)).

The primary outcome is of mere descriptive nature. Therefore, no control group is created and the participants are not blinded or randomized.

For the secondary outcomes, every tested subject serves as its own control (cross over). The gait analysis as well as the questionnaire are performed three times. The two measurements after the first familiarization measurements are performed in a randomized order.
Primary purpose: SCREENING

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.

Eligibility criteria: 1. Inclusion criteria for descriptive study:

   a. Lower limb amputation (independently of side or height of amputation)
2. Inclusion criteria for Phantom stimulator:

   1. Receptive fields present at testing day 31 (last regular assessment of the receptive fields)
   2. Lower limb amputation below the knee (if both sides the system is applied to the dominant side).
3. Exclusion criteria:

   1. Implanted devices (defibrillator or pacemaker)
   2. Pregnancy

Primary outcomes:
measure: Description of receptive Fields Size in cm2
timeFrame: 4-5 Weeks (7 hours)
measure: Description of receptive Fields Position in % overlapping from first measurement
timeFrame: 4-5 Weeks (7 hours)
Secondary outcomes:
measure: Change in gait parameters through Phantom Stimulator
timeFrame: 1/2 Day (3 hours)
measure: Change in phantom sensations through Phantom Stimulator
timeFrame: 1/2 Day (3 hours)
Other outcomes:
Locations:
city: Bellikon
country: Switzerland
facility: Rehaklinik Bellikon
state: Aargau
Study officials:
affiliation: Reahklinik Bellikon
name: Marion Grögli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: