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Descriptive Study of Receptive Fields in Lower Limb Amputees

NCT03348605 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-11-21

No results posted yet for this study

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.

Conditions

  • Lower Limb Amputation Below Knee (Injury)

Interventions

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.

Sponsors & Collaborators

  • Cort X Sensorics GmbH

    collaborator UNKNOWN

  • Rehaklinik Bellikon

    lead OTHER

Principal Investigators

  • Marion Grögli, Dr. med. · Reahklinik Bellikon

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-27
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348605 on ClinicalTrials.gov