Descriptive Study of Receptive Fields in Lower Limb Amputees

Rehaklinik Bellikon

Status: Unknown

Conditions: Lower Limb Amputation Below Knee (Injury)

Treatments: Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany

Study type: Interventional

Funder types: Other

Identifiers

NCT03348605

01_2017

2017-01621 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

35 participants in 2 patient groups

First setting ON

Other group

Description:

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.

Treatment:

Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany

First setting OFF

Other group

Description:

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.

Treatment:

Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany