Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Gait Disorders, Neurologic
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Balance training
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, gait, balance, falls
Eligibility Criteria
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.).
Sites / Locations
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Balance training
Control group
Arm Description
Patients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
Patients included in the control group who did not received any intervention
Outcomes
Primary Outcome Measures
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.
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04484480
First Posted
July 20, 2020
Last Updated
July 28, 2020
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT04484480
Brief Title
Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes
Official Title
Balance and Motion Coordination Parameters Can be Improved in Patients - Non-randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
It is estimated that by the end of 2017 year, there will be 462 millions of patients suffering from diabetes mellitus type II (DMII), what is about 6% of world population (4,4% between 15 and 49 years of age, 15% between 50 and 69 years and 22% of patients older than 70 years). It is predicted that by the beginning of 2030, number of cases on 100000 people will grow from 6059 up to 7079. There are studies proving that cardiovascular complications related to the diabetes are responsible for 4 millions of deaths annually. The newest epidemiological data suggest that growing number of DMII cases is no longer a problem in developed countries but also affects developing ones. As potential risk factors, well proved in the literature authors reported alcoholism, nicotinism, high body-mass index (BMI) and positive family history. It is therefore anticipated that the prevalence of one of its common complications, a diabetic peripheral neuropathy (DPN), will increase as well. It is broadly recognized that a DPN leads to a decrement in distal lower limb sensory function; however, there is also a neuropathy-related decrease in distal motor function, even among those with relatively mild diabetic disease. It is well proven in the literature, that diabetes mellitus influences negatively function of peripheral nervous system by damaging sensory fibers. A high risk of falls has been reported in the diabetic population, with an overall incidence of 1.25 falls/person-year.It was proven that short-period strength and balance exercises do not improves diabetic patients quality of life However they have positive influence on the functional outcome of those people. Influence of DMII on motion system is not limited only to the peripheral nervous system. It also affects structures of cerebrum such as: cerebral cortex, cerebellum or basal nuclei. DMII affects motor and somatosensory cerebral atrophy what leads to changes in projection tracts associated with them. In cerebellum it affects on the vermis and parts of lobes responsible for receiving impulses from the spinal cord and controlling proximal parts of muscles, which are crucial for movement coordination during gait. Disorders caused by DMII in basal nuclei result in longer response time and slower gait velocity. Together with pharmacological and dietary interventions, exercise interventions including resistance training, represent the cornerstones of type 2 diabetes management. In addition to the beneficial effects of exercise interventions on glycemic control and on the cardiovascular risk factors associated with type 2 diabetes, physical exercise is an effective intervention to improve muscle strength, power output, cardiovascular function and functional capacity in elderly diabetic patients. In elderly diabetics with severe functional decline, multicomponent exercise programs composed of resistance, endurance, balance and gait retraining should be employed to increase functional capacity and quality of life and to avoid disability and falls. The aim of the study was to evaluate balance and motor coordination parameters in patients treated for type 2 diabetes who received biofeedback-equivalent training using the Biodex dynamometric platform.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Gait Disorders, Neurologic
Keywords
diabetes, gait, balance, falls
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator an outcomes assessor were blinded for the information whether analyzed participant was in the interventional group or control one.
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance training
Arm Type
Experimental
Arm Description
Patients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients included in the control group who did not received any intervention
Intervention Type
Procedure
Intervention Name(s)
Balance training
Intervention Description
Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
Primary Outcome Measure Information:
Title
Fall risk test
Description
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.
Time Frame
3-months after inclusion to the study
Title
General Stability Index
Description
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
Time Frame
3-months after inclusion to the study
Title
Frontal-Posterior Stability Index)
Description
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
Time Frame
3-months after inclusion to the study
Title
Medial-Lateral Stability Index
Description
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
Time Frame
3-months after inclusion to the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Artur Stolarczyk, MD, PhD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Othopedics and Rehabilitation, Medical University of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
03-984
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets used during the current study are not publicly available because of patient integrity but are available from the corresponding author on reasonable request
IPD Sharing Time Frame
Data will be available on reasonable request for 36 months
Citations:
PubMed Identifier
36281192
Citation
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.
Results Reference
derived
PubMed Identifier
34217288
Citation
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.
Results Reference
derived
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Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes
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