AmputationNCT06046300
The Relationship Between Trunk Position Sense and Muscle Activation, Balance and Quality of Life in Amputees
An observational study of Amputation and Muscle Activation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. Individuals with unilateral transtibial amputation who have been using prostheses for at least 1 year and volunteered to participate in the… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Muscle Activation, Balance
- What is being tested?
- Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 25 Oct 2025
- How long will I take part?
- 1 Day
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study group consisted of individuals with transtibial amputation who volunteered to participate in the study and came to Hacettepe University Faculty of Physical Therapy and Rehabilitation, Prosthesis-Orthotics and Biomechanics Unit and Bilim Orthotics Prosthesis Center; The control group will consist of healthy individuals in the immediate vicinity who volunteered to participate in the study.
Who may be able to join
- For Transtibial Amputation Group;
- Having a traumatic unilateral transtibial amputation,
- Using prosthesis for at least 1 year,
- K2 and K3 functional classification according to K level,
- Between the ages of 18-45,
- Having received standard physiotherapy methods (prosthesis training),
Show all 11Show fewer
- It was determined as individuals who volunteered to participate in the study. For the Healthy Group;
- Between the ages of 18-45,
- Having similar demographic characteristics with the individuals in the transtibial amputee group,
- No neurological and/or orthopedic problems,
- Individuals who agreed to participate in the study voluntarily.
Who cannot join
- For both groups;
- Having hip, knee or ankle joint limitation,
- Having muscle shortness that prevents walking and other activities,
- Having a history of falling in the last 1 year,
- Body mass index (BMI) >30 kg/m²,
- Individuals using a walking aid. For the Amputation Group;
- Having phantom pain,
- Individuals with any disease or systemic health problem that may affect their gait other than amputation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Trunk Position Sense and Muscle Activation, Balance and Quality of Life in Individuals With Transtibial Amputation
This study was planned to examine the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. Individuals with unilateral transtibial amputation who have been using prostheses for at least 1 year and volunteered to participate in the study, as well as healthy individuals with similar demographic characteristics will be included in the study. The number of cases considered to be included in the study will be obtained from the statistical analysis of the results of the pilot study to be conducted with 5 individuals, since there is no study on the subject. The power of the study will be determined as 0.80. After determining the number of individuals to be included in the study group, a control group will be formed with the same number of healthy individuals. The study will be terminated when the determined total number of participants is reached. Body position sense, trunk muscle activation, static and dynamic balance performances and quality of life of all individuals will be evaluated. Body position sense of individuals with "Dualer IQ Pro Digital Inclinometer" device, trunk muscle activation with "Delsys Trigno IM wireless surface electromyography (sEMG) system", balance with "Bertec balance platform", balance and functional mobility with "Berg Balance Scale (BDI) ", "Timed Up and Go Test (SKYT)" and "Modified Star Excursion Test (SEBT)" and quality of life will be evaluated with "Trinity Amputation and Prosthesis Experience Scale (TAPES)". As a result of our study, investigators think that it will contribute to the current scientific knowledge about the somatosensory and biomechanical mechanisms underlying the abnormalities that occur in the trunk after transtibial amputation, to determine whether the trunk position sense of individuals with transtibial amputation is affected or not, and to determine the relationship between trunk position sense and muscle activation, balance and quality of life.
Read the detailed description
Amputation is a major trauma that significantly disrupts the biomechanics of the musculoskeletal system, results in serious physical and psychological losses, and affects the quality of life, social and professional life of the individual.
Following lower extremity amputation, somatosensory input, muscle activity, and joint mobility decrease in the amputated part of the extremity.
The ability to maintain postural stability is one of the most important aspects of our daily lives.
While standing, the postural control system adjusts the center of pressure and gathers inputs from the visual, vestibular, and somatosensory systems (i.e. proprioceptive and cutaneous senses) to maintain the center of gravity on the base of support.
The ability to maintain balance is severely impaired following lower extremity amputation.
As the stump fails to compensate for the lack of foot and ankle as a proprioceptive organ, the postural control system is reprogrammed and compensatory mechanisms are developed to prevent weight-bearing asymmetries, somatosensory loss, reduced support surface, and increased joint stiffness.
These changes are also reflected in changes in neuromuscular motor output, such as postural sway during standing.
Although used prostheses are an alternative to partially reduce deficiencies, current prosthetic technologies do not provide enough sensory feedback.
Persons with lower extremity amputations exhibit abnormal trunk movement during functional tasks than non-injured persons.
As shown in studies, an asymmetrical posture and balance problem occurs in individuals with amputation.
The resulting asymmetry can be associated with chronic neuromuscular problems such as back and extremity pain, vascular diseases, and early arthritis.
Controlled trunk movement is essential for balance and stability while walking. Individuals with lower extremity amputations often exhibit abnormal trunk movement, but the underlying mechanisms are not well understood.
Lower extremity amputation results in loss of muscles, tendons, ligaments and joint capsule, severely affecting the lower extremity and thus body function.
These structures are not only essential for movement, they also function as sensory receptors, and when lost, proprioception suffers.
It includes conscious proprioception, kinesthesia, strength sense, and joint position sense.
Several studies have investigated changes in proprioception in individuals with transtibial amputation and have presented different results.
Fontes et al. concluded that asymmetric body weight distribution was not accompanied by a decrease in knee proprioception in transtibial amputees.
Latanioti et al. They stated that when joint position sense at 15° was evaluated, stump proprioceptive knowledge was not significantly affected after knee amputation and prosthesis application, and the loss of knee sensory receptors in these individuals was compensated by alternative mechanisms.
Liao and Skinner concluded that there is a significant difference in knee joint proprioception between prosthetic and intact limbs in persons with below-knee amputation.
Eakin et al. They designed a proprioception measurement system to evaluate lower extremity knee joint proprioception in 10 above-knee amputees.
The system allowed subjects to be tested in a position simulating the late swing phase of gait.
The ability to repeat the lower extremity positions specified for the intact and prosthetic extremities of the subjects was recorded for the detection of slow passive movement.
As a result of the study, a significant difference was detected between the passive motion detection threshold of the amputated and intact extremities; however, they stated that there was no significant difference between passive motion reposition of amputated and intact extremities.
This finding demonstrates the importance of hip joint motion appreciation when these motions are relevant in the proprioception of the prosthetic knee joint of amputees.
However, prosthetic limb passive motion positioning error decreases with age, which may improve amputees' ability to use the remaining lower extremity proprioceptive mechanisms to compensate for the loss of anatomical knee joint structures.
There are many studies in the literature examining position sense, muscle activity, balance and quality of life in individuals with transtibial amputation.
However, studies have focused on the lower extremities. Individuals with transtibial amputation often have abnormal trunk movement, but the mechanisms underlying this abnormality in terms of trunk are not well understood.
Information on trunk muscle activity and trunk position sense in individuals with transtibial amputation is very limited.
In the current literature, the trunk position sense of individuals with transtibial amputation and the relationship of trunk position sense with muscle activation, balance and quality of life.
Therefore, in this study, it is aimed to investigate whether the trunk position sense, including the trunk right and left sides of the individuals with transtibial amputation, is affected and the relationship between trunk position sense and muscle activation, balance and quality of life.
- Conditions
- Amputation, Muscle Activation, Balance, Quality of Life, Sense of Control
- Being tested
- Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.
- Keywords
- Transtibial amputation, Sense of position, Muscle activation, Balance, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.Diagnostic test
It is aimed to investigate whether the trunk position sense, including the trunk right and left sides of the individuals with transtibial amputation, is affected and the relationship between trunk position sense and muscle activation, balance and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Amputees | Individuals with a transtibial amputation Receives: Diagnostic Test: Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. | |
| Healthy | Healthy individuals Receives: Diagnostic Test: Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Position Sense measurement
Thanks to dual-sensor measurement with Dualer IQ Pro Digital Inclinometer, spine evaluations can be made by collecting easy and reliable data. The device is recommended by the American Medical Association (AMA). It is a calibrated device with a 1 degree margin of error, used in the measurement of joint range of motion and position sense in the clinic. It determines the potential difference between the two end heads and converts this potential difference to the corresponding joint angle to measure the range of motion of the spine and limbs without a computer.
Measured: 30 minutes
Secondary outcomes (1)
Trunk Muscle Activation measurement
Evaluation of erector spinals (m. Longissimus, m. iliocostalis), lumbal multifidus, rectus abdominis and external oblique muscle activations will be performed using the Delsys Trigno IM (Delsys Inc. Natick, Massachusetts, USA) wireless surface electromyography (sEMG) system. The evaluation of trunk muscle activation will be made with the Bertec balance platform during the balance evaluation, and the surface electrodes that will be used to record the electromyography (EMG) signals of the trunk muscles will be selected and applied in accordance with the recommendations of SENIAM (Surface ElectromyoGraphy for the Non-Invasive Assessment of Muscles).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Feb 2025 (estimated)
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Topuz, Hacettepe University
- Investigators
- Ozlem Ulger, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046300
- Sponsor's protocol ID
- GO 21/1104
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Trunk Position Sense and Muscle Activation, Balance and Quality of Life in Individuals With Transtibial Amputation
- ClinicalTrials.gov ID
- NCT06046300
- Acronym / sponsor ID
- GO 21/1104
- Conditions
- Amputation, Muscle Activation, Balance, Quality of Life, Sense of Control
- Keywords
- Transtibial amputation, Sense of position, Muscle activation, Balance, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
This study was planned to examine the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation. Individuals with unilateral transtibial amputation who have been using prostheses for at least 1 year and volunteered to participate in the study, as well as healthy individuals with similar demographic characteristics will be included in the study. The number of cases considered to be included in the study will be obtained from the statistical analysis of the results of the pilot study to be conducted with 5 individuals, since there is no study on the subject. The power of the study will be determined as 0.80. After determining the number of individuals to be included in the study group, a control group will be formed with the same number of healthy individuals. The study will be terminated when the determined total number of participants is reached. Body position sense, trunk muscle activation, static and dynamic balance performances and quality of life of all individuals will be evaluated. Body position sense of individuals with "Dualer IQ Pro Digital Inclinometer" device, trunk muscle activation with "Delsys Trigno IM wireless surface electromyography (sEMG) system", balance with "Bertec balance platform", balance and functional mobility with "Berg Balance Scale (BDI) ", "Timed Up and Go Test (SKYT)" and "Modified Star Excursion Test (SEBT)" and quality of life will be evaluated with "Trinity Amputation and Prosthesis Experience Scale (TAPES)". As a result of our study, investigators think that it will contribute to the current scientific knowledge about the somatosensory and biomechanical mechanisms underlying the abnormalities that occur in the trunk after transtibial amputation, to determine whether the trunk position sense of individuals with transtibial amputation is affected or not, and to determine the relationship between trunk position sense and muscle activation, balance and quality of life.
Detailed description
Amputation is a major trauma that significantly disrupts the biomechanics of the musculoskeletal system, results in serious physical and psychological losses, and affects the quality of life, social and professional life of the individual.
Following lower extremity amputation, somatosensory input, muscle activity, and joint mobility decrease in the amputated part of the extremity.
The ability to maintain postural stability is one of the most important aspects of our daily lives.
While standing, the postural control system adjusts the center of pressure and gathers inputs from the visual, vestibular, and somatosensory systems (i.e. proprioceptive and cutaneous senses) to maintain the center of gravity on the base of support.
The ability to maintain balance is severely impaired following lower extremity amputation.
As the stump fails to compensate for the lack of foot and ankle as a proprioceptive organ, the postural control system is reprogrammed and compensatory mechanisms are developed to prevent weight-bearing asymmetries, somatosensory loss, reduced support surface, and increased joint stiffness.
These changes are also reflected in changes in neuromuscular motor output, such as postural sway during standing.
Although used prostheses are an alternative to partially reduce deficiencies, current prosthetic technologies do not provide enough sensory feedback.
Persons with lower extremity amputations exhibit abnormal trunk movement during functional tasks than non-injured persons.
As shown in studies, an asymmetrical posture and balance problem occurs in individuals with amputation.
The resulting asymmetry can be associated with chronic neuromuscular problems such as back and extremity pain, vascular diseases, and early arthritis.
Controlled trunk movement is essential for balance and stability while walking. Individuals with lower extremity amputations often exhibit abnormal trunk movement, but the underlying mechanisms are not well understood.
Lower extremity amputation results in loss of muscles, tendons, ligaments and joint capsule, severely affecting the lower extremity and thus body function.
These structures are not only essential for movement, they also function as sensory receptors, and when lost, proprioception suffers.
It includes conscious proprioception, kinesthesia, strength sense, and joint position sense.
Several studies have investigated changes in proprioception in individuals with transtibial amputation and have presented different results.
Fontes et al. concluded that asymmetric body weight distribution was not accompanied by a decrease in knee proprioception in transtibial amputees.
Latanioti et al. They stated that when joint position sense at 15° was evaluated, stump proprioceptive knowledge was not significantly affected after knee amputation and prosthesis application, and the loss of knee sensory receptors in these individuals was compensated by alternative mechanisms.
Liao and Skinner concluded that there is a significant difference in knee joint proprioception between prosthetic and intact limbs in persons with below-knee amputation.
Eakin et al. They designed a proprioception measurement system to evaluate lower extremity knee joint proprioception in 10 above-knee amputees.
The system allowed subjects to be tested in a position simulating the late swing phase of gait.
The ability to repeat the lower extremity positions specified for the intact and prosthetic extremities of the subjects was recorded for the detection of slow passive movement.
As a result of the study, a significant difference was detected between the passive motion detection threshold of the amputated and intact extremities; however, they stated that there was no significant difference between passive motion reposition of amputated and intact extremities.
This finding demonstrates the importance of hip joint motion appreciation when these motions are relevant in the proprioception of the prosthetic knee joint of amputees.
However, prosthetic limb passive motion positioning error decreases with age, which may improve amputees' ability to use the remaining lower extremity proprioceptive mechanisms to compensate for the loss of anatomical knee joint structures.
There are many studies in the literature examining position sense, muscle activity, balance and quality of life in individuals with transtibial amputation.
However, studies have focused on the lower extremities. Individuals with transtibial amputation often have abnormal trunk movement, but the mechanisms underlying this abnormality in terms of trunk are not well understood.
Information on trunk muscle activity and trunk position sense in individuals with transtibial amputation is very limited.
In the current literature, the trunk position sense of individuals with transtibial amputation and the relationship of trunk position sense with muscle activation, balance and quality of life.
Therefore, in this study, it is aimed to investigate whether the trunk position sense, including the trunk right and left sides of the individuals with transtibial amputation, is affected and the relationship between trunk position sense and muscle activation, balance and quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amputees | – | Diagnostic Test: Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.Individuals with a transtibial amputation |
| Healthy | – | Diagnostic Test: Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.Healthy individuals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group consisted of individuals with transtibial amputation who volunteered to participate in the study and came to Hacettepe University Faculty of Physical Therapy and Rehabilitation, Prosthesis-Orthotics and Biomechanics Unit and Bilim Orthotics Prosthesis Center; The control group will consist of healthy individuals in the immediate vicinity who volunteered to participate in the study.
Key inclusion criteria (11 listed)
- For Transtibial Amputation Group;
- Having a traumatic unilateral transtibial amputation,
- Using prosthesis for at least 1 year,
- K2 and K3 functional classification according to K level,
- Between the ages of 18-45,
Key exclusion criteria (8 listed)
- For both groups;
- Having hip, knee or ankle joint limitation,
- Having muscle shortness that prevents walking and other activities,
- Having a history of falling in the last 1 year,
- Body mass index (BMI) >30 kg/m²,
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 |
|---|---|---|
| Investigation of the relationship between trunk position sense and muscle activation, balance and quality of life in individuals with transtibial amputation.It is aimed to investigate whether the trunk position sense, including the trunk right and left sides of the individuals with transtibial amputation, is affected and the relationship between trunk position sense and muscle activation, balance and quality of life. | Diagnostic test | Amputees, Healthy |
Primary outcome
Trunk Position Sense measurement
Time frame: 30 minutes
Thanks to dual-sensor measurement with Dualer IQ Pro Digital Inclinometer, spine evaluations can be made by collecting easy and reliable data. The device is recommended by the American Medical Association (AMA). It is a calibrated device with a 1 degree margin of error, used in the measurement of joint range of motion and position sense in the clinic. It determines the potential difference between the two end heads and converts this potential difference to the corresponding joint angle to measure the range of motion of the spine and limbs without a computer.
1 secondary outcome
Trunk Muscle Activation measurement
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Ozlem Ulger study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Muscle Activation, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. 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 6 Oct 2023. 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 Turkey (Türkiye). 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?
Contact Semra TOPUZ (03123051576, fztsemra@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Position Sense measurement (time frame: 30 minutes). 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 6 Oct 2023.