Diabetes Mellitus, Type 2NCT04484480
Balance and Motion Coordination Parameters Can be Improved in Patients With Type 2 Diabetes
A study testing Balance training in people with Diabetes Mellitus, Type 2 and Gait Disorders, Neurologic, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Gait Disorders, Neurologic
- What is being tested?
- Balance training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 03-984
About this study
Official title: 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.
Read the 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.
- Being tested
- Balance training
- Keywords
- diabetes, gait, balance, falls
- Medical subject headings
- Diabetes Mellitus, Type 2, Gait Disorders, Neurologic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingProcedure or surgery
Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Balance training |
| Control group | No intervention | Patients included in the control group who did not received any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 3-months after inclusion to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Artur Stolarczyk, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484480
- Sponsor's protocol ID
- Gait DM
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 36281192Stolarczyk 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.
PubMed 34217288
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Motion Coordination Parameters Can be Improved in Patients - Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04484480
- Acronym / sponsor ID
- Gait DM
- Keywords
- diabetes, gait, balance, falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Procedure: Balance trainingPatients included in the study group, who received 3-month proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System. |
| Control group | No intervention | –Patients included in the control group who did not received any intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance trainingProprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System. | Procedure or surgery | Balance training |
Primary outcome
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 36281192Adamska 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.
- Derived from this study: PubMed 34217288Stolarczyk 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Artur Stolarczyk, MD, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Diabetes Mellitus, Type 2 and Gait Disorders, Neurologic, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall risk test (time frame: 3-months after inclusion to the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04484480, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.