Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes

NCT04484480 | Completed

• 1 other identifier: Gait DM
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus type II (DMII) causes many complications, including retinopathy and peripheral neuropathy. These complications are well understood and believed to contribute to gait instability and increase the risk of falls. Poor balance control and increased falling risk have also been reported in people with diabetic peripheral neuropathy (DPN). Patients with DPN are at an increased risk of falling due to the decreased proprioceptive feedbacks. Effective balance training should improve instabilities of postural control in patients with DPN. For this purpose, evaluations and balance training was designed. The goal of our study was to establish values for proprioception, balance, muscle coordination and strength in patients with DMII, who underwent biofeedback balance training using the Biodex Balance System.

Conditions

Diabetes Mellitus, Type 2; Gait Disorders, Neurologic

Keywords

diabetes; gait; balance; falls

Outcome Measures

Primary Outcomes (4)

• Fall risk test

  Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials. The lower the values of the fall index were, the better the result.

  3-months after inclusion to the study

• General Stability Index

  Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials

  3-months after inclusion to the study

• Frontal-Posterior Stability Index)

  Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials

  3-months after inclusion to the study

• Medial-Lateral Stability Index

  Test performed with use of Biodex platform to measure participant's ability to maintain the center of gravity on an unstable substrate in three 20-second trials

  3-months after inclusion to the study

Study Arms (2)

Balance training

EXPERIMENTAL

Patients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.

Procedure: Balance training

Control group

NO INTERVENTION

Patients included in the control group who did not received any intervention

Interventions

Balance training PROCEDURE

Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.

Balance training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• willingness to participate in the study
• age over 65
• diagnosed type 2 diabetes, subjected to pharmacological treatment (study group)
• no type 2 diabetes (control group)

You may not qualify if:

• unwillingness to participate in the study
• age below 65 years
• surgical intervention in the lower limbs or spine during the last 6 months
• symptoms of osteoarthritis or pain of another origin around the lower limbs or spine
• rheumatic diseases (eg. rheumatoid arthritis, ankylosing spondylitis)
• diagnosed neuromuscular disease
• strongly manifested imbalances due to impairment of central or peripheral nervous system
• neurological disorders with dizziness, nystagmus, dermatologic or profound (cerebrospinal syndrome, dizziness, multiple sclerosis, Parkinson's disease, etc.).

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-984, Poland

Location

Related Publications (2)

• Adamska O, Mamcarz A, Lapinski M, Radzimowski K, Stepinski P, Szymczak J, Swiercz M, Zarnovsky K, Maciag BM, Stolarczyk A. Continuous glycemia monitoring in perioperative period in patients undergoing total knee or hip arthroplasty: A protocol for a prospective observational study. Medicine (Baltimore). 2022 Oct 21;101(42):e31107. doi: 10.1097/MD.0000000000031193.

  PMID: 36281192 DERIVED

• Stolarczyk A, Jarzemski I, Maciag BM, Radzimowski K, Swiercz M, Stolarczyk M. Balance and motion coordination parameters can be improved in patients with type 2 diabetes with physical balance training: non-randomized controlled trial. BMC Endocr Disord. 2021 Jul 3;21(1):143. doi: 10.1186/s12902-021-00804-8.

  PMID: 34217288 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Gait Disorders, Neurologic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Artur Stolarczyk, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator an outcomes assessor were blinded for the information whether analyzed participant was in the interventional group or control one.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available on reasonable request for 36 months

Locations

PL (1)