Clinical trial NCT05177341: Investigating The Effect of Phantom Sensation on Gait in Individuals With Unilateral Below-Knee Amputation
Official title: Investigating Whether Phantom Sensation Affects Autocorrelation Features of Individuals With Unilateral Below-Knee Amputation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation, Traumatic
Phantom Sensation
Keywords: Amputation
Phantom Sensation
Gait
Autocorrelation Function
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2022-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic transtibial amputees or age and gender matched healthy individuals

Brief summary: Amputation is a problem that can be encountered for many reasons, can cause functional disability in varying severities and puts a multifaceted financial burden on individuals, society, and states. The phantom feeling is the state of the sensory sensation of a limb that does not already exist and is observed in various forms in individuals with amputation.

The aim of this project is to investigate whether the phantom sensation affects autocorrelation of gait in unilateral amputated individuals and thus to determine whether the phantom sensation is a functional sensation that affects the multifaceted nature of gait. In addition, the measurement of whether phantom sensation contributes to the ability of amputees to adapt to changing conditions and obtaining a unique calculation method that determines autocorrelation are other specific aspects of the study. The study will be conducted on individuals with unilateral traumatic transtibial amputation who have acceptable phantom sensation, individuals with no-phantom sensation and healthy individuals. Individuals who meet the inclusion criteria will be included in the gait assessment. During the evaluation, at least 512 consecutive steps will be collected from each individual when walking on the treadmill at their preferred speed. The walk test will then be repeated on the perturbation treadmill of 5-10%. It will be determined whether the gait characteristics obtained by gait analysis show autocorrelation by using signal processing methods.

Detailed description: Amputation is a problem that can be encountered for many reasons, can cause functional disability in varying severities and puts a multifaceted financial burden on individuals, society, and states. The phantom feeling is the state of the sensory sensation of a limb that does not already exist and is observed in various forms in individuals with amputation.

The aim of this project is to investigate whether the phantom sensation affects autocorrelation of gait in unilateral amputated individuals and thus to determine whether the phantom sensation is a functional sensation that affects the multifaceted nature of gait. In addition, the measurement of whether phantom sensation contributes to the ability of amputees to adapt to changing conditions and obtaining a unique calculation method that determines autocorrelation are other specific aspects of the study. The study will be conducted on individuals with unilateral traumatic transtibial amputation who have acceptable phantom sensation, individuals with no-phantom sensation and healthy individuals. Individuals who meet the inclusion criteria will be included in the gait assessment. During the evaluation, at least 512 consecutive steps will be collected from each individual when walking on the treadmill at their preferred speed. The walk test will then be repeated on the perturbation treadmill of 5-10%. It will be determined whether the gait characteristics obtained by gait analysis show autocorrelation by using signal processing methods.

Eligibility criteria: Group 1 (amputated individuals with phantom sensation) inclusion criteria:

* Having an acceptable (non-irritating) phantom sensation that persists throughout the day, even if the severity is variable
* Having unilateral below-knee amputation due to trauma
* Using OttoBock® prosthesis with dynamic foot component, silicone liner design and active vacuum system: The reason for choosing this prosthesis; This is because it is a prosthesis documented in the literature, with the highest standards of use in today's conditions, the most preferred in the international platform, used in research, and advantageous for use in daily life. Thus, deficiencies that may arise from the design of the prosthesis will not be encountered.
* At least 2 years have passed since amputation surgery
* Using the last prosthesis for at least 6 months for at least 6-8 hours a day
* Being within the limits of body mass index (weight/height2: 18.5-24.9 kg/m2) accepted as normal by the World Health Organization
* Having the ability to speak and understand Turkish
* Not having any balance and coordination difficulties that can be observed with clinical functional tests
* Not having any joint contracture or muscle shortness that may affect walking ability
* Agree to participate in the study

Group 1 (amputated individuals with phantom sensation) exclusion criteria:

* Undergoing amputation surgery for non-traumatic reasons
* Having multiple amputations
* To be followed up with any medical pre-diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
* To be followed up with any medical diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
* Being on medication during the research
* Having consumed alcohol in the last 48 hours
* Taking painkillers in the last 48 hours
* Having a history of surgery and acute trauma in the last 6 months
* Having a history of falling in the last 1 year
* Loss of sensation in the remaining limb (stump) after amputation
* Having a disturbing phantom feeling
* Having any chronic and/or acute pain, including phantom pain and stump pain
* Observing any shortness, contracture or balance problems in the pre-tests

Group 2 - (amputated individuals without phantom sensation) inclusion criteria:

* Having unilateral below-knee amputation due to trauma
* Volunteering to participate in the study
* Using OttoBock® prosthesis with dynamic foot component, silicone liner design and active vacuum system (Picture 1)
* At least 2 years have passed since amputation surgery
* Using the last prosthesis for at least 6 months for at least 6-8 hours a day
* Being within the limits of body mass index (weight/height2: 18.5-24.9 kg/m2) accepted as normal by the World Health Organization
* Having the ability to speak and understand Turkish
* Absence of phantom sensation at any time and movement in the last 4 weeks

Group 2 - (amputated individuals without phantom sensation) exclusion criteria:

* Undergoing amputation surgery for non-traumatic reasons
* Having multiple amputations
* To be followed up with any medical pre-diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
* To be followed up with any medical diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
* Being on medication during the research
* Having consumed alcohol in the last 48 hours
* Taking painkillers in the last 48 hours
* Having a history of surgery and acute trauma in the last 6 months
* Having a history of falling in the last 1 year
* Loss of sensation in the remaining limb (stump) after amputation
* Having a phantom feeling
* Having any chronic and/or acute pain, including phantom pain and stump pain
* Observing any shortness, contracture or balance problems in the pre-tests

Group 3 - (healthy volunteers) inclusion criteria:

* Being within the limits of body mass index (weight/height2: 18.5-24.9 kg/m2) accepted as normal by the World Health Organization
* Having the ability to speak and understand Turkish
* Agree to participate in the study

Group 3 - (healthy volunteers) exclusion criteria:

* To be followed up with any medical pre-diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
* To be followed up with any medical diagnosis (orthopedic, neurological, cardiovascular, psychiatric, etc.)
* Being on medication during the research
* Having consumed alcohol in the last 48 hours
* Taking painkillers in the last 48 hours
* Having a history of surgery and acute trauma in the last 6 months
* Having a history of falling in the last 1 year
* Observing any shortness, contracture or balance problems in the pre-tests

Primary outcomes:
measure: Gait Analysis on Flat Ground
timeFrame: 5 minutes after the protocol for determining the preferred walking speed
measure: Gait analysis on Perturbed Ground
timeFrame: 5 minutes after walking on the flat ground
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hinton DC, Cheng YY, Paquette C. Everyday multitasking habits: University students seamlessly text and walk on a split-belt treadmill. Gait Posture. 2018 Jan;59:168-173. doi: 10.1016/j.gaitpost.2017.10.011. Epub 2017 Oct 7.
citation: Aminian K, Dadashi F, Mariani B, Lenoble-Hoskovec C, Santos-Eggimann B, Büla CJ. Gait analysis using shoe-worn inertial sensors: how is foot clearance related to walking speed? Proceedings of the 2014 ACM international joint conference on Pervasive and ubiquitous computing. 2014; 481-485.