- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484480
Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes
Balance and Motion Coordination Parameters Can be Improved in Patients - Non-randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mazowieckie
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Warsaw, Mazowieckie, Poland, 03-984
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Balance training
Patients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
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Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
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NO_INTERVENTION: Control group
Patients included in the control group who did not received any intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fall risk test
Time Frame: 3-months after inclusion to the study
|
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.
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3-months after inclusion to the study
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General Stability Index
Time Frame: 3-months after inclusion to the study
|
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)
Time Frame: 3-months after inclusion to the study
|
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
Time Frame: 3-months after inclusion to the study
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Artur Stolarczyk, MD, PhD, Medical University of Warsaw
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gait DM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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