Amputation, TraumaticNCT05177341
Investigating The Effect of Phantom Sensation on Gait in Individuals With Unilateral Below-Knee Amputation
An observational study of Amputation, Traumatic and Phantom Sensation, run by Trakya University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Traumatic, Phantom Sensation
- What is being tested?
- Determining Preferred Walking Speed
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Sep 2022
- Phase
- Observational
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Traumatic transtibial amputees or age and gender matched healthy individuals
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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigating Whether Phantom Sensation Affects Autocorrelation Features of Individuals With Unilateral Below-Knee Amputation
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.
Read the 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.
- Conditions
- Amputation, Traumatic, Phantom Sensation
- Being tested
- Determining Preferred Walking Speed
- Keywords
- Amputation, Phantom Sensation, Gait, Autocorrelation Function
- Medical subject headings
- Amputation, Traumatic, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining Preferred Walking SpeedOther
In the beginning, sensors of the gait analysis system (RehaGait®), which can record the time-distance characteristics of consecutive multiple steps (step length, step width, double step length, and timing information, etc.) will be installed. The 7 sensors of this system are attached to the shoes of the individual, proximal to the ankle, distal thigh, and sacroiliac joint level (Aminian et al., 2014). Individuals will be required to wear casual athletic shoes and comfortable, non-knee-covering shorts. Next; Each individual will walk freely on the treadmill at their own pace. To find the preferred walking speed of the individual, Hinton et al. protocol will be used (Hinton et al., 2018). The speed of the treadmill will be increased or decreased in line with the direction of the participants. After being determined according to the protocol, the individual will practice walking at this speed for 4-5 minutes. The individual will rest as much as he or she wants.
| Study group | Role | What they receive |
|---|---|---|
| Amputees with acceptable phantom sensation | Not described Receives: Other: Determining Preferred Walking Speed | |
| Amputees with no phantom sensation | Not described Receives: Other: Determining Preferred Walking Speed | |
| Control group | Not described Receives: Other: Determining Preferred Walking Speed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis on Flat Ground
In order to collect the data required for the autocorrelation calculation in flat walking, the subject will be placed on the treadmill (REAX RUN) and he or she will be asked to continue his walking at the "preferred speed" level obtained with the previous protocol, until at least 512 steps are collected. This walk is expected to take 3-4 minutes in total. After a sufficient number of steps is reached, the treadmill will be gradually slowed down and stopped. Afterward, the individual will be taken to rest again.
Measured: 5 minutes after the protocol for determining the preferred walking speed
Gait analysis on Perturbed Ground
After the resting period is terminated, the individual will start walking at the speed determined according to the Hinton protocol on the treadmill (REAX RUN) for gait analysis again. During the second walk, 5-10% perturbation will be given on the treadmill until 512 steps are collected. The autocorrelation analysis to be performed with the data taken during walking on the perturbed ground will measure the adaptability of the individual's gait to changing conditions. The data of the walk will be automatically saved on the system computer. Whether the autocorrelation feature of the gait is observed or not will be calculated mathematically using signal processing methods.
Measured: 5 minutes after walking on the flat ground
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amputation, TraumaticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hilal Hotaman, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177341
- Sponsor's protocol ID
- TÜTF-BAEK 2018/451
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29032000Aminian 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Whether Phantom Sensation Affects Autocorrelation Features of Individuals With Unilateral Below-Knee Amputation
- ClinicalTrials.gov ID
- NCT05177341
- Acronym / sponsor ID
- TÜTF-BAEK 2018/451
- Conditions
- Amputation, Traumatic, Phantom Sensation
- Keywords
- Amputation, Phantom Sensation, Gait, Autocorrelation Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 4 Jan 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amputees with acceptable phantom sensation | – | Other: Determining Preferred Walking Speed |
| Amputees with no phantom sensation | – | Other: Determining Preferred Walking Speed |
| Control group | – | Other: Determining Preferred Walking Speed |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Traumatic transtibial amputees or age and gender matched healthy individuals
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 |
|---|---|---|
| Determining Preferred Walking SpeedIn the beginning, sensors of the gait analysis system (RehaGait®), which can record the time-distance characteristics of consecutive multiple steps (step length, step width, double step length, and timing information, etc.) will be installed. The 7 sensors of this system are attached to the shoes of the individual, proximal to the ankle, distal thigh, and sacroiliac joint level (Aminian et al., 2014). Individuals will be required to wear casual athletic shoes and comfortable, non-knee-covering shorts. Next; Each individual will walk freely on the treadmill at their own pace. To find the preferred walking speed of the individual, Hinton et al. protocol will be used (Hinton et al., 2018). The speed of the treadmill will be increased or decreased in line with the direction of the participants. After being determined according to the protocol, the individual will practice walking at this speed for 4-5 minutes. The individual will rest as much as he or she wants. | Other | Amputees with acceptable phantom sensation, Amputees with no phantom sensation, Control group |
Primary outcome
Gait Analysis on Flat Ground
Time frame: 5 minutes after the protocol for determining the preferred walking speed
In order to collect the data required for the autocorrelation calculation in flat walking, the subject will be placed on the treadmill (REAX RUN) and he or she will be asked to continue his walking at the "preferred speed" level obtained with the previous protocol, until at least 512 steps are collected. This walk is expected to take 3-4 minutes in total. After a sufficient number of steps is reached, the treadmill will be gradually slowed down and stopped. Afterward, the individual will be taken to rest again.
Gait analysis on Perturbed Ground
Time frame: 5 minutes after walking on the flat ground
After the resting period is terminated, the individual will start walking at the speed determined according to the Hinton protocol on the treadmill (REAX RUN) for gait analysis again. During the second walk, 5-10% perturbation will be given on the treadmill until 512 steps are collected. The autocorrelation analysis to be performed with the data taken during walking on the perturbed ground will measure the adaptability of the individual's gait to changing conditions. The data of the walk will be automatically saved on the system computer. Whether the autocorrelation feature of the gait is observed or not will be calculated mathematically using signal processing methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 29032000Hinton 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.
- BackgroundAminian 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic and Phantom Sensation, run by Trakya University.
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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Hilal Keklicek, Ph.D. (+905384855543, hhotaman23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Analysis on Flat Ground (time frame: 5 minutes after the protocol for determining the preferred walking speed). 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?
On the ClinicalTrials.gov record for NCT05177341, which also lists 2 linked publications.
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 4 Jan 2022.