Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees

NCT05542901 | Completed

• 1 other identifier: GO 21/1101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Polyneuropathy; Amputation

Keywords

Diabetic Polyneuropathy; Lower Extremity Amputation; Joint Position Sense; Compliance With The Prosthesis; Balance; Functional Performance

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (3)

• The Limits of Stability

  1 week

• Postural Sway

  1 week

• Functional Capacity

  1 week

Study Arms (2)

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.

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.

Diagnostic Test: Joint Position Sense Analysis

Interventions

Joint Position Sense Analysis DIAGNOSTIC_TEST

The Xsens DOT Motion Capture System will be used to analyze joint position sense.

Diabetic Group (DG); Traumatic Group (TG)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33909824 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Melek M. ERDEM, PT, M.Sc.

  Tayyip Erdogan University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Semra TOPUZ, PT, Prof.

  Hacettepe University

  STUDY DIRECTOR

• Ali I. YALCIN, PT, Ph.D.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: September 13, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 9, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available within 3 months with completion of the result report.
• Access Criteria: Requestors will be required to sign a Data Access Agreement.

Locations

TU (1)