Descriptive Study of Receptive Fields in Lower Limb Amputees
NCT ID: NCT03348605
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
35 participants
INTERVENTIONAL
2017-10-27
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
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.
SCREENING
SINGLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
First setting ON
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.
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.
First setting OFF
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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).
Exclusion Criteria
2. Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cort X Sensorics GmbH
UNKNOWN
Rehaklinik Bellikon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marion Grögli, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Reahklinik Bellikon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rehaklinik Bellikon
Bellikon, Canton of Aargau, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Website of study site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-01621
Identifier Type: OTHER
Identifier Source: secondary_id
01_2017
Identifier Type: -
Identifier Source: org_study_id