Descriptive Study of Receptive Fields in Lower Limb Amputees and the Effect of a Related Stimulation System on Selected Gait Parameters
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Description of receptive Fields Size in cm2
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria for descriptive study:
- •a. 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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in gait parameters through Phantom Stimulator(1/2 Day (3 hours))
- Change in phantom sensations through Phantom Stimulator(1/2 Day (3 hours))