NCT03348605

Descriptive Study of Receptive Fields in Lower Limb Amputees

Descriptive Study of Receptive Fields in Lower Limb Amputees and the Effect of a Related Stimulation System on Selected Gait Parameters

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Rehaklinik Bellikon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Limb Amputation Below Knee (Injury)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-27
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2017-11-21
• Last updated: 2017-11-21

Locations

1 site across 1 country: Switzerland