Descriptive Study of Receptive Fields in Lower Limb Amputees

Lower Limb Amputation Below Knee (Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03348605
• Other study ID #: 01_2017
• Secondary ID: 2017-01621
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 30, 2017
• Last updated: November 15, 2017
• Start date: October 27, 2017
• Est. completion date: July 2018

Study information

• Verified date: November 2017
• Source: Rehaklinik Bellikon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation Below Knee (Injury)

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Rehaklinik Bellikon	Bellikon	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Rehaklinik Bellikon	Cort X Sensorics GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of receptive Fields Size in cm2	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.	4-5 Weeks (7 hours)
Primary	Description of receptive Fields Position in % overlapping from first measurement	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.	4-5 Weeks (7 hours)
Secondary	Change in gait parameters through Phantom Stimulator	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).	1/2 Day (3 hours)
Secondary	Change in phantom sensations through Phantom Stimulator	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).	1/2 Day (3 hours)

External Links

•   Website of study site