Diabetic PolyneuropathyNCT05542901
Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees
A study testing Joint Position Sense Analysis in people with Diabetic Polyneuropathy and Amputation, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Polyneuropathy, Amputation
- What is being tested?
- Joint Position Sense Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2022to 9 Jun 2023
- Phase
- Interventional
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic Group (DG):
- Those who had unilateral transtibial amputation due to DPN
- Between the ages of 40-65
- Completed rehabilitation with prosthesis
- Using prosthesis for at least 1 year
- With standard size stump length
Show all 25Show fewer
- Without phantom sensation and pain
- Able to walk at least 10 m independently
- Gross lower extremity muscle strength at least moderate
- No cognitive and mental problems
- Diabetic nephropathy, retinopathy, ulceration etc. without secondary complications
- Those who voluntarily agreed to participate in the research
- Not included in any other concurrent study
- Traumatic Group (TG):
- Those who had trauma-induced unilateral transtibial amputation
- Between the ages of 40-65
- Completed rehabilitation with prosthesis
- Using prosthesis for at least 1 year
- With standard size stump length
- Without phantom sensation and pain
- Able to walk at least 10 m independently
- Gross lower extremity muscle strength is at least moderate
- Absence of cognitive and mental problems
- Those who voluntarily agreed to participate in the research
- Not included in any other concurrent study
Who cannot join
- For all groups;
- Having osteoarticular deformity in the knee joint
- Having an orthopedic or neurological disease other than the cause of amputation
- Significant and irreversible visual deficit
- Body mass index (BMI)>30 kg/m²
- Having a disability that makes it hard to complete any of the tests
- Individuals with a history of cancer and receiving chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees and The Investigation of The Relationship Between Compliance With a Prosthesis, Balance, and Functional Performance With Joint Position Sense
This study evaluated the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to diabetic polyneuropathy. Study group consisted of 16 subjects with unilateral transtibial amputation due to diabetic polyneuropathy and control group consisted of 16 subjects with unilateral transtibial amputation due to traumatic reasons.
Read the detailed description
Proprioception is defined as the ability to distinguish the position of various body parts relative to each other and the ground through the sensory system (kinesthesia) and to perceive the forces acting on these body parts. Proprioception is a function that takes place mainly on a subconscious level. Information about the external environment we live in is obtained from the combination of nerve terminals in muscles and tendons, fibrous capsules around joints, vestibular and visual systems. The proprioceptive information obtained about the external environment through the peripheral nervous system is transferred to the central nervous system. The integration of these data collected from different sensory receptors is performed, and appropriate motor responses are initiated to ensure postural balance. Sensory loss due to pain, fatigue, effusion, trauma, or various neurological, musculoskeletal disorders and metabolic diseases such as diabetes often causes a decrease in proprioceptive sensation in these case groups. Peripheral nerve damage due to diabetic polyneuropathy (DPN), varies depending on the type of nerve fiber affected. As a result of damage to unmyelinated and small myelinated nerve fibers, light touch, pain and temperature senses are impaired while vibration and proprioception senses are decreased as a result of damage to large myelinated nerve fibers. Recent studies have shown that individuals with DPN are more likely to apply to the emergency department due to complications from fall accidents because they experience balance loss during activities of daily living compared to healthy non-diabetic individuals. Furthermore, foot biomechanics, which deteriorates owing to the loss of the normal neural feedback system caused by DPN, causes foot ulcerations by creating aberrant pressure distribution in the foot. In these people, non-healing lower limb ulcers account for 85% of planned lower extremity amputations. Due to the predicted loss of soft tissue, bone, and sensory receptors in the amputated limb following a prior lower extremity amputation, which results in musculoskeletal system degradation and destruction of the mechanoreceptors innervating these tissues, the way these individuals experience their surroundings changes and differentiates them from individuals who have been amputated due to traumatic causes. Diabetic amputees are unable to utilize their prostheses functionally following amputation due to their physical problems, which results in the majority of patients discontinuing usage of prosthesis. Although the number of test batteries developed to assess proprioceptive sense and the effectiveness of rehabilitation protocols used to assess proprioceptive sense in individuals with musculoskeletal disorders such as amputation is insufficient in the literature, it is believed that the existing batteries do not adequately assess proprioceptive sense. Additionally, no study has been conducted to determine the extent to which these patients' proprioceptive sensibility is altered following lower limb amputation due to DPN. For this reason, the study was planned to examine the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to DPN.
- Conditions
- Diabetic Polyneuropathy, Amputation
- Being tested
- Joint Position Sense Analysis
- Keywords
- Diabetic Polyneuropathy, Lower Extremity Amputation, Joint Position Sense, Compliance With The Prosthesis, Balance, Functional Performance
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Position Sense AnalysisDiagnostic test
The Xsens DOT Motion Capture System will be used to analyze joint position sense.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Group (DG) | Other | Examine the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to diabetic polyneuropathy. Receives: Diagnostic Test: Joint Position Sense Analysis |
| Traumatic Group (TG) | Other | Examine the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to traumatic causes. Receives: Diagnostic Test: Joint Position Sense Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Sense
The Xsens DOT Motion Capture System will be used in the evaluation of knee joint proprioception. . Before starting the measurement, the sensors are properly attached to the patient. The sense of proprioception of the knee joint will be evaluated bilaterally with weightless (NWB) using the method. The NWB assessment will be performed with and without prosthesis while the person is in a sitting position with their legs fully supported. The person's eyes will be covered with a band aid to avoid any visual cues. The knee joint in extension position will be slowly brought to the target angle value of 30° and 60° flexion position by the physiotherapist and waited for 4 seconds. After 3 consecutive attempts, the participant will be asked to actively perform the flexion movement whose angle is determined using the same limb. There will be 2 minute rest breaks between measurements. The difference between the target angle and the measured angle is recorded as the margin of error.
Measured: 1 week
Secondary outcomes (3)
The Limits of Stability
The limits of stability were used to evaluate static balance. Limits of stability is the greatest distance in any direction a person can lean away from a midline vertical position without falling, stepping, or reaching for support. Participants were assessed with a force platform (Model BP 5050; Bertec Corporation, Columbus, Ohio) in terms of support surfaces on limits of stability (LoS) in the right, left, front and back directions when the eyes were open on the hard floor with the Bertec Balance System on their preferred support surface width.
Measured: 1 week
Postural Sway
Postural sways were used to evaluate dynamic balance. Postural sway, in terms of human sense of balance, refers to horizontal movement around the center of gravity. Postural sway was measured while quiet standing with open/closed eyes on a hard/soft floor using the Bertec Balance System at their preferred support surface width.
Measured: 1 week
Functional Capacity
2 Minute Walk test was used to evaluate the functional capacity. The test was performed in a corridor on a flat hard surface of 30 m in length in a straight line. Before the examination, the patient rested for 10 min in a sitting position. It is calculated by measuring the distance that the person walks at the end of this period by asking the person to walk for 2 minutes along a 30 m corridor. In cases of chest pain, dyspnea, leg cramps, excessive fatigue, sweating and wilting, the test should be terminated immediately. At one-minute intervals during the test, the participant received information about the time remaining until the end of the test.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start13 Sep 2022
- Primary completion15 May 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic PolyneuropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Melek Merve ERDEM, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Melek M. ERDEM, PT, M.Sc., Principal investigator, Tayyip Erdogan University Training and Research HospitalSemra TOPUZ, PT, Prof., Study director, Hacettepe UniversityAli I. YALCIN, PT, Ph.D., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542901
- Sponsor's protocol ID
- GO 21/1101
- Status last verified
- Jun 2023
- First submitted
- 13 Sep 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Fontes Filho CHDS, Laett CT, Gavilao UF, Campos JC Jr, Alexandre DJA, Cossich VRA, Sousa EB. Bodyweight distribution between limbs, muscle strength, and proprioception in traumatic transtibial amputees: a cross-sectional study. Clinics (Sao Paulo). 2021 Apr 26;76:e2486. doi: 10.6061/clinics/2021/e2486. eCollection 2021.
PubMed 33909824
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees and The Investigation of The Relationship Between Compliance With a Prosthesis, Balance, and Functional Performance With Joint Position Sense
- ClinicalTrials.gov ID
- NCT05542901
- Acronym / sponsor ID
- GO 21/1101
- Conditions
- Diabetic Polyneuropathy, Amputation
- Keywords
- Diabetic Polyneuropathy, Lower Extremity Amputation, Joint Position Sense, Compliance With The Prosthesis, Balance, Functional Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 16 Sep 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.
This study evaluated the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to diabetic polyneuropathy. Study group consisted of 16 subjects with unilateral transtibial amputation due to diabetic polyneuropathy and control group consisted of 16 subjects with unilateral transtibial amputation due to traumatic reasons.
Detailed description
Proprioception is defined as the ability to distinguish the position of various body parts relative to each other and the ground through the sensory system (kinesthesia) and to perceive the forces acting on these body parts. Proprioception is a function that takes place mainly on a subconscious level. Information about the external environment we live in is obtained from the combination of nerve terminals in muscles and tendons, fibrous capsules around joints, vestibular and visual systems. The proprioceptive information obtained about the external environment through the peripheral nervous system is transferred to the central nervous system. The integration of these data collected from different sensory receptors is performed, and appropriate motor responses are initiated to ensure postural balance. Sensory loss due to pain, fatigue, effusion, trauma, or various neurological, musculoskeletal disorders and metabolic diseases such as diabetes often causes a decrease in proprioceptive sensation in these case groups. Peripheral nerve damage due to diabetic polyneuropathy (DPN), varies depending on the type of nerve fiber affected. As a result of damage to unmyelinated and small myelinated nerve fibers, light touch, pain and temperature senses are impaired while vibration and proprioception senses are decreased as a result of damage to large myelinated nerve fibers. Recent studies have shown that individuals with DPN are more likely to apply to the emergency department due to complications from fall accidents because they experience balance loss during activities of daily living compared to healthy non-diabetic individuals. Furthermore, foot biomechanics, which deteriorates owing to the loss of the normal neural feedback system caused by DPN, causes foot ulcerations by creating aberrant pressure distribution in the foot. In these people, non-healing lower limb ulcers account for 85% of planned lower extremity amputations. Due to the predicted loss of soft tissue, bone, and sensory receptors in the amputated limb following a prior lower extremity amputation, which results in musculoskeletal system degradation and destruction of the mechanoreceptors innervating these tissues, the way these individuals experience their surroundings changes and differentiates them from individuals who have been amputated due to traumatic causes. Diabetic amputees are unable to utilize their prostheses functionally following amputation due to their physical problems, which results in the majority of patients discontinuing usage of prosthesis. Although the number of test batteries developed to assess proprioceptive sense and the effectiveness of rehabilitation protocols used to assess proprioceptive sense in individuals with musculoskeletal disorders such as amputation is insufficient in the literature, it is believed that the existing batteries do not adequately assess proprioceptive sense. Additionally, no study has been conducted to determine the extent to which these patients' proprioceptive sensibility is altered following lower limb amputation due to DPN. For this reason, the study was planned to examine the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to DPN.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Diabetic Group (DG) | Other | Diagnostic Test: Joint Position Sense AnalysisExamine the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to diabetic polyneuropathy. |
| Traumatic Group (TG) | Other | Diagnostic Test: Joint Position Sense AnalysisExamine the effect of joint position sense on compliance with the prosthesis, balance and functional performance in individuals with lower extremity amputation due to traumatic causes. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Those who had unilateral transtibial amputation due to DPN
- Between the ages of 40-65
- Completed rehabilitation with prosthesis
- Using prosthesis for at least 1 year
- With standard size stump length
Key exclusion criteria (7 listed)
- For all groups;
- Having osteoarticular deformity in the knee joint
- Having an orthopedic or neurological disease other than the cause of amputation
- Significant and irreversible visual deficit
- 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 |
|---|---|---|
| Joint Position Sense AnalysisThe Xsens DOT Motion Capture System will be used to analyze joint position sense. | Diagnostic test | Diabetic Group (DG), Traumatic Group (TG) |
Primary outcome
Joint Position Sense
Time frame: 1 week
The Xsens DOT Motion Capture System will be used in the evaluation of knee joint proprioception. . Before starting the measurement, the sensors are properly attached to the patient. The sense of proprioception of the knee joint will be evaluated bilaterally with weightless (NWB) using the method. The NWB assessment will be performed with and without prosthesis while the person is in a sitting position with their legs fully supported. The person's eyes will be covered with a band aid to avoid any visual cues. The knee joint in extension position will be slowly brought to the target angle value of 30° and 60° flexion position by the physiotherapist and waited for 4 seconds. After 3 consecutive attempts, the participant will be asked to actively perform the flexion movement whose angle is determined using the same limb. There will be 2 minute rest breaks between measurements. The difference between the target angle and the measured angle is recorded as the margin of error.
3 secondary outcomes
The Limits of Stability
Time frame: 1 week
Postural Sway
Time frame: 1 week
Functional Capacity
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 33909824Fontes Filho CHDS, Laett CT, Gavilao UF, Campos JC Jr, Alexandre DJA, Cossich VRA, Sousa EB. Bodyweight distribution between limbs, muscle strength, and proprioception in traumatic transtibial amputees: a cross-sectional study. Clinics (Sao Paulo). 2021 Apr 26;76:e2486. doi: 10.6061/clinics/2021/e2486. eCollection 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Melek M. ERDEM, PT, M.Sc. principal investigator
Tayyip Erdogan University Training and Research Hospital
Semra TOPUZ, PT, Prof. study director
Hacettepe University
Ali I. YALCIN, PT, Ph.D. study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Position Sense Analysis in people with Diabetic Polyneuropathy and Amputation, run by Recep Tayyip Erdogan University Training and Research Hospital 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 25 inclusion and 7 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: finished, as of the sponsor's last update on 12 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Position Sense (time frame: 1 week). 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 NCT05542901, which also lists 1 linked publication.
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 12 Jun 2023.