Diabetes MellitusNCT01861392
Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial
A study testing sensorio-motor training in people with Diabetes Mellitus and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: The individual's ability to sustain itself in the upright position, effectively adjusting the body's movements and reacting to external stimuli, postural control strategies represent essential activities of daily living. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Quality of Life, Exercise Therapy
- What is being tested?
- sensorio-motor training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Dec 2016
- 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 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of diabetes mellitus type 2 with controlled blood glucose
- Absence of skin lesions or fractures of the lower limbs in the last 6 months -Plantar malformations
- Severe postural abnormalities and limb length difference.
Who cannot join
- Use of medications that can have negative effects on the function of cognition, attention and psychomotor (ie, opioids, antiepileptics, anxiolytics, antipsychotics, hypnotics and sedatives)
- Diagnosis of cardiovascular, neurological, rheumatological and musculoskeletal disorders that may interfere with activities of daily living
- Presence of vestibular disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rinaldo Roberto de Jesus Guirro
Ribeirão Preto, São Paulo
Rinaldo Jesus Guirro, PHD, +551636024584, rguirro@fmrp.usp.br
Ariane H M Pletsch, PHD student, +551636020462, ariane_mansano@usp.br
About this study
Background: The individual's ability to sustain itself in the upright position, effectively adjusting the body's movements and reacting to external stimuli, postural control strategies represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered a more problem of Public Health as having complications deficit in functional performance of the lower limbs and falls, which can interfere with the maintenance of balance, and is a strong predictor of functional limitations self referred. Aim: To assess quality of life and the answers neuromuscular balance and baropodometric after sensory-motor training in patients with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor training. Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. There will be a follow up after 3 months of intervention. Statistical analysis will be used normality test to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and adopted a significance level of 5%. Expected Results: Considering previous studies that demonstrate improvement in postural balance static and dynamic responses under the forward training protocol sensorimotor disease Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant, the joint position sense and the quality of life of voluntary DM-2.
Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus, quality of life.
- Conditions
- Diabetes Mellitus, Quality of Life, Exercise Therapy, Postural Balance
- Being tested
- sensorio-motor training
- Keywords
- postural balance sensory motor trayning physical therapy modalities diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorio-motor trainingProcedure or surgery
Also called quality of life
| Study group | Role | What they receive |
|---|---|---|
| sensory-motor training | Active comparator | Guidelines + sensory-motor training.Evaluation Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. Receives: Procedure: sensorio-motor training |
| guidelines | Active comparator | receive the same guidelines and reviews that group orientation and training sensorineural engine and will be guided home exercises for postural twice a week 45 minutes for 12 weeks. Receives: Procedure: sensorio-motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural balance training diabetic type 2
Measured: four years
Secondary outcomes (1)
Quality of life of diabetics type 2
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Ariane H M Pletsch, PHD Student, Principal investigator, University of Sao PauloRinaldo Roberto Jesus Guirro, PHD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861392
- Sponsor's protocol ID
- U1111-1143-3618
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
PubMed 15111519Suprak DN. Shoulder joint position sense is not enhanced at end range in an unconstrained task. Hum Mov Sci. 2011 Jun;30(3):424-35. doi: 10.1016/j.humov.2011.02.003. Epub 2011 Mar 27.
PubMed 21444119Vandekerckhove M, Vermeire E, Weeren A, Van Royen P. Validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with type 2 diabetes in a Belgian population. Prim Care Diabetes. 2009 Feb;3(1):43-7. doi: 10.1016/j.pcd.2009.02.003. Epub 2009 Mar 4.
PubMed 19264569Song CH, Petrofsky JS, Lee SW, Lee KJ, Yim JE. Effects of an exercise program on balance and trunk proprioception in older adults with diabetic neuropathies. Diabetes Technol Ther. 2011 Aug;13(8):803-11. doi: 10.1089/dia.2011.0036. Epub 2011 May 11.
PubMed 21561371Borges NCS, Pletsch AHM, Buzato MB, Terada NAY, Cruz FMFD, Guirro RRJ. The effect of proprioceptive training on postural control in people with diabetes: A randomized clinical trial comparing delivery at home, under supervision, or no training. Clin Rehabil. 2021 Jul;35(7):988-998. doi: 10.1177/0269215521989016. Epub 2021 Jan 28.
PubMed 33508955
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial
- ClinicalTrials.gov ID
- NCT01861392
- Acronym / sponsor ID
- U1111-1143-3618
- Conditions
- Diabetes Mellitus, Quality of Life, Exercise Therapy, Postural Balance
- Keywords
- postural balance sensory motor trayning physical therapy modalities diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 May 2013 (estimated)
- 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.
Background: The individual's ability to sustain itself in the upright position, effectively adjusting the body's movements and reacting to external stimuli, postural control strategies represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered a more problem of Public Health as having complications deficit in functional performance of the lower limbs and falls, which can interfere with the maintenance of balance, and is a strong predictor of functional limitations self referred. Aim: To assess quality of life and the answers neuromuscular balance and baropodometric after sensory-motor training in patients with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor training. Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. There will be a follow up after 3 months of intervention. Statistical analysis will be used normality test to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and adopted a significance level of 5%. Expected Results: Considering previous studies that demonstrate improvement in postural balance static and dynamic responses under the forward training protocol sensorimotor disease Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant, the joint position sense and the quality of life of voluntary DM-2.
Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus, quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensory-motor training | Active comparator | Procedure: sensorio-motor trainingGuidelines + sensory-motor training.Evaluation Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. |
| guidelines | Active comparator | Procedure: sensorio-motor trainingreceive the same guidelines and reviews that group orientation and training sensorineural engine and will be guided home exercises for postural twice a week 45 minutes for 12 weeks. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus type 2 with controlled blood glucose
- Absence of skin lesions or fractures of the lower limbs in the last 6 months -Plantar malformations
- Severe postural abnormalities and limb length difference.
Key exclusion criteria (3 listed)
- Use of medications that can have negative effects on the function of cognition, attention and psychomotor (ie, opioids, antiepileptics, anxiolytics, antipsychotics, hypnotics and sedatives)
- Diagnosis of cardiovascular, neurological, rheumatological and musculoskeletal disorders that may interfere with activities of daily living
- Presence of vestibular disorders
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 |
|---|---|---|
| sensorio-motor trainingAlso: quality of life | Procedure or surgery | guidelines, sensory-motor training |
Primary outcome
Postural balance training diabetic type 2
Time frame: four years
1 secondary outcome
Quality of life of diabetics type 2
Time frame: four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Background: PubMed 15111519Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.
- Background: PubMed 21444119Suprak DN. Shoulder joint position sense is not enhanced at end range in an unconstrained task. Hum Mov Sci. 2011 Jun;30(3):424-35. doi: 10.1016/j.humov.2011.02.003. Epub 2011 Mar 27.
- Background: PubMed 19264569Vandekerckhove M, Vermeire E, Weeren A, Van Royen P. Validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with type 2 diabetes in a Belgian population. Prim Care Diabetes. 2009 Feb;3(1):43-7. doi: 10.1016/j.pcd.2009.02.003. Epub 2009 Mar 4.
- Background: PubMed 21561371Song CH, Petrofsky JS, Lee SW, Lee KJ, Yim JE. Effects of an exercise program on balance and trunk proprioception in older adults with diabetic neuropathies. Diabetes Technol Ther. 2011 Aug;13(8):803-11. doi: 10.1089/dia.2011.0036. Epub 2011 May 11.
- Derived from this study: PubMed 33508955Borges NCS, Pletsch AHM, Buzato MB, Terada NAY, Cruz FMFD, Guirro RRJ. The effect of proprioceptive training on postural control in people with diabetes: A randomized clinical trial comparing delivery at home, under supervision, or no training. Clin Rehabil. 2021 Jul;35(7):988-998. doi: 10.1177/0269215521989016. Epub 2021 Jan 28.
- Related InfoLink provided by the sponsor.
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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.
Ariane H M Pletsch, PHD Student principal investigator
University of Sao Paulo
Rinaldo Roberto Jesus Guirro, PHD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensorio-motor training in people with Diabetes Mellitus and Quality of Life, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 May 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane H.M Pletsch, PHD student (+551636020462 ext. Brazil, ariane_mansano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural balance training diabetic type 2 (time frame: four years). 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 NCT01861392, which also lists 5 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 23 May 2013.