Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05542901
Study type Interventional
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact
Status Completed
Phase N/A
Start date September 13, 2022
Completion date June 9, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Enrolling by invitation NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04839497 - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. Phase 2
Recruiting NCT04212299 - Transfemoral Socket Design and Muscle Function N/A
Completed NCT03733054 - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed NCT03651830 - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT04936789 - Clinical Feasibility of the IMES Transradial Prosthesis N/A
Completed NCT01155024 - Clinical Evaluation of Direct Manufactured Prosthetic Sockets Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Recruiting NCT00388752 - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation Phase 1
Active, not recruiting NCT03374319 - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations N/A
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed NCT05778799 - Physical Activity and Sports for People With Special Needs
Recruiting NCT04804150 - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System N/A
Terminated NCT03259386 - Movement and Sensation for Advanced Prosthetic Hands
Recruiting NCT05601869 - Impact of Improving Footwear Options N/A