Descriptive Study of Receptive Fields in Lower Limb Amputees

NCT03348605 | Unknown

• 2 other identifiers: 01_20172017-01621
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

Amputation; Phantom Pain; Gait analysis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Change in gait parameters through Phantom Stimulator

  1/2 Day (3 hours)

• Change in phantom sensations through Phantom Stimulator

  1/2 Day (3 hours)

Study Arms (2)

First setting ON

OTHER

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.

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

First setting OFF

OTHER

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.

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

Interventions

Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany DEVICE

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.

First setting OFF; First setting ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Lower limb amputation (independently of side or height of amputation)
• Receptive fields present at testing day 31 (last regular assessment of the receptive fields)
• Lower limb amputation below the knee (if both sides the system is applied to the dominant side).

You may not qualify if:

• Implanted devices (defibrillator or pacemaker)
• Pregnancy

Sponsors & Collaborators

• Rehaklinik Bellikon: lead
• Cort X Sensorics GmbH: collaborator

Study Sites (1)

Rehaklinik Bellikon

Bellikon, Canton of Aargau, 5454, Switzerland

Location

Related Links

• Website of study site

MeSH Terms

Conditions

Wounds and Injuries; Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Marion Grögli, Dr. med.

  Reahklinik Bellikon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: As this study is described as single blinded, the only entity of the trial not aware of the group or sequence of the participant is the participant itself. The other personell involved in the trial needs to be aware of the position of the participant within the study so to apply the right measures. In this case the participant is unaware of the fact whether his stimulation system is turned on or off.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 21, 2017
• Study Start: October 27, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)