Lower Limb Amputation Below Knee (Injury)NCT03348605
Descriptive Study of Receptive Fields in Lower Limb Amputees
A study testing Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany in people with Lower Limb Amputation Below Knee (Injury), run by Rehaklinik Bellikon at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Oct 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion criteria for descriptive study:
- Lower limb amputation (independently of side or height of amputation)
- Inclusion criteria for Phantom stimulator:
- 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).
- Exclusion criteria:
- Implanted devices (defibrillator or pacemaker)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of Receptive Fields in Lower Limb Amputees and the Effect of a Related Stimulation System on Selected Gait Parameters
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.
Read the 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.
- Being tested
- Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany
- Keywords
- Amputation, Phantom Pain, Gait analysis
- Medical subject headings
- Wounds and Injuries, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phantom Stimulator, Cort X Sensorics, Spaichingen, GermanyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4-5 Weeks (7 hours)
Secondary outcomes (2)
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).
Measured: 1/2 Day (3 hours)
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).
Measured: 1/2 Day (3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start27 Oct 2017
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehaklinik Bellikon
- Sponsor type
- University, hospital or other
- Collaborators
- Cort X Sensorics GmbH
- Responsible party
- Sponsor
- Investigators
- Marion Grögli, Dr. med., Principal investigator, Reahklinik Bellikon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348605
- Sponsor's protocol ID
- 01_2017
- Other IDs
- 2017-01621, 2017
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is used only internally the study concerning the Phantom Stimulator (Cort X Sensorics, Spaichingen Germany). The IPD is shared with the responsible investigative parties of the Rehaklinik Bellikon only. It will be available to the participant after completion of the study. The data obtained from the Study results in a publication after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Receptive Fields in Lower Limb Amputees and the Effect of a Related Stimulation System on Selected Gait Parameters
- ClinicalTrials.gov ID
- NCT03348605
- Acronym / sponsor ID
- 01_2017
- Keywords
- Amputation, Phantom Pain, Gait analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Rehaklinik BellikonUniversity, hospital or other
- Collaborators
- Cort X Sensorics GmbH
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| First setting ON | Other | Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, GermanyThis 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. |
| First setting OFF | Other | Device: Phantom Stimulator, Cort X Sensorics, Spaichingen, GermanyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phantom Stimulator, Cort X Sensorics, Spaichingen, GermanyThis 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. | Device | First setting OFF, First setting ON |
Primary outcome
Description of receptive Fields Size in cm2
Time frame: 4-5 Weeks (7 hours)
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.
Description of receptive Fields Position in % overlapping from first measurement
Time frame: 4-5 Weeks (7 hours)
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.
2 secondary outcomes
Change in gait parameters through Phantom Stimulator
Time frame: 1/2 Day (3 hours)
Change in phantom sensations through Phantom Stimulator
Time frame: 1/2 Day (3 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Website of study siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD is used only internally the study concerning the Phantom Stimulator (Cort X Sensorics, Spaichingen Germany). The IPD is shared with the responsible investigative parties of the Rehaklinik Bellikon only. It will be available to the participant after completion of the study. The data obtained from the Study results in a publication after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Grögli, Dr. med. principal investigator
Reahklinik Bellikon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany in people with Lower Limb Amputation Below Knee (Injury), run by Rehaklinik Bellikon at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of receptive Fields Size in cm2 (time frame: 4-5 Weeks (7 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.