Investigating The Effect of Phantom Sensation on Gait in Individuals With Unilateral Below-Knee Amputation

NCT ID: NCT05177341

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-09-30

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.

Conditions

Amputation, Traumatic; Phantom Sensation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Amputees with acceptable phantom sensation

Determining Preferred Walking Speed

Intervention Type: OTHER

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.

Amputees with no phantom sensation

Determining Preferred Walking Speed

Intervention Type: OTHER

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.

Control group

Determining Preferred Walking Speed

Intervention Type: OTHER

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.

Interventions

Determining Preferred Walking Speed

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• 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

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

• 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

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Hilal Hotaman

PhD, Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hilal Keklicek, Ph.D.

Role: CONTACT

hhotaman23@gmail.com

+905384855543

References

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.

Reference Type: BACKGROUND

PMID: 29032000 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

TÜTF-BAEK 2018/451

Identifier Type: -

Identifier Source: org_study_id