Clinical trial NCT05542901: Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Amputation
Keywords: Diabetic Polyneuropathy
Lower Extremity Amputation
Joint Position Sense
Compliance With The Prosthesis
Balance
Functional Performance
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2022-09-16
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SCREENING

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Diabetic Group (DG):

1. Those who had unilateral transtibial amputation due to DPN
2. Between the ages of 40-65
3. Completed rehabilitation with prosthesis
4. Using prosthesis for at least 1 year
5. With standard size stump length
6. Without phantom sensation and pain
7. Able to walk at least 10 m independently
8. Gross lower extremity muscle strength at least moderate
9. No cognitive and mental problems
10. Diabetic nephropathy, retinopathy, ulceration etc. without secondary complications
11. Those who voluntarily agreed to participate in the research
12. Not included in any other concurrent study

Traumatic Group (TG):

1. Those who had trauma-induced unilateral transtibial amputation
2. Between the ages of 40-65
3. Completed rehabilitation with prosthesis
4. Using prosthesis for at least 1 year
5. With standard size stump length
6. Without phantom sensation and pain
7. Able to walk at least 10 m independently
8. Gross lower extremity muscle strength is at least moderate
9. Absence of cognitive and mental problems
10. Those who voluntarily agreed to participate in the research
11. Not included in any other concurrent study

Exclusion Criteria:

For all groups;

1. Having osteoarticular deformity in the knee joint
2. Having an orthopedic or neurological disease other than the cause of amputation
3. Significant and irreversible visual deficit
4. Body mass index (BMI)\>30 kg/m²
5. Having a disability that makes it hard to complete any of the tests
6. Individuals with a history of cancer and receiving chemotherapy

Primary outcomes:
measure: Joint Position Sense
timeFrame: 1 week
Secondary outcomes:
measure: The Limits of Stability
timeFrame: 1 week
measure: Postural Sway
timeFrame: 1 week
measure: Functional Capacity
timeFrame: 1 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altindag
Study officials:
affiliation: Tayyip Erdogan University Training and Research Hospital
name: Melek M. ERDEM, PT, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Semra TOPUZ, PT, Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ali I. YALCIN, PT, Ph.D.
role: STUDY_CHAIR
References:
citation: 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.