Diabetes Mellitus, Type 2NCT03390959
Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
A study testing Proprioceptive Training in people with Diabetes Mellitus, Type 2, run by Kelly Antunes e Silva Oliveira at 1 site in Brazil.
Trial summary
Introduction: Diabetes mellitus (DM) can be considered as one of the most important chronic diseases in the public health system, presenting a high cost for health services. Along with the increase in diagnosed cases of DM, there is a simultaneous increase in DM-related manifestations, such as peripheral diabetic… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Proprioceptive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2017to 30 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals with type 2 diabetes mellitus, diagnosed for at least 3 years
- both genders
- aged 45 years or over
- able to wander without assistance or supervision from others
- absence of macroangiopathy
- no history of neurological, muscular or rheumatic diseases for the etiology of diabetes
- agree to participate in the study, signing the Free and Informed Consent Term (TCLE) pursuant to Resolution 466/12 of the National Health Council
Who cannot join
- presence of uncontrolled hypertension (systolic ≥ 200 mmHg and / or diastolic ≤100 mmHg);
- presence of a rheumatic condition that makes it impossible to perform the movements performed in the evaluation and in the therapeutic intervention;
- lack of more than 15% to the proprioceptive training program;
- individuals who perform some physical activity
- dependence on alcohol and illicit drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Maria das Graças Araujo
Recife, Pernambuco, 50670-901
About this study
Official title: Effectiveness of Proprioceptive Training on Plantar Pressure, Postural Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
Introduction: Diabetes mellitus (DM) can be considered as one of the most important chronic diseases in the public health system, presenting a high cost for health services. Along with the increase in diagnosed cases of DM, there is a simultaneous increase in DM-related manifestations, such as peripheral diabetic neuropathy, diabetic foot ulcers and amputations. Decreased plantar sensitivity caused by microvascular complications, reduced sensation of vibration and loss of pressure sensitivity may be associated with recurrent falls due to reduced proprioceptive feedback. Although much is known about the beneficial results of physical exercise on glucose metabolism and insulin action, there are still few studies that evaluate the effects of different types of physical exercise, especially proprioceptive training, on plantar pressure, balance and posture of individuals.
Objective: The present study aims to evaluate the efficacy of proprioceptive training on plantar pressure, postural balance and posture in adults with Type 2 Diabetes Mellitus.
Methods: This study is a randomized, double blind, controlled clinical trial (evaluator and statistician) with individuals of both sexes, with type 2 diabetes mellitus diagnosed for at least 3 years, over 45 years of age, that can walk without assistance or supervision of others. Two groups will be formed, the Control Group (CG) and the Trained Group (TG), and the ideal "n" will be calculated in a pilot study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Proprioceptive Training, Control Group
- Keywords
- Proprioception, Diabetes Mellitus, Type 2, Postural Balance, Gait, Posture
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive TrainingOther
Also called Experimental
Individuals in the Trained Group will perform the training twice a week for 45 minutes and perform for a period of 12 weeks.
The training is divided into a pre-training phase where general hip dissociation exercises and simple stretching of the hip flexor and extensor muscle groups, knee, foot and paravertebral are performed.
The second phase is the proprioceptive training, where it will involve training of balance, sensitivity and proprioception, being used a circuit composed of 15 stations, whose time of stay in each station is 2 minutes.
And finally the third stage are relaxation exercises, performed with breathing exercises associated with slow active movements of the joints.
Control GroupOther
Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Training | Experimental | The group participates in proprioceptive training that promotes sensory integration. Receives: Other: Proprioceptive Training |
| Control Group | Other | The group continues in their daily lives with phone monitoring. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar Pressure
Modular baropodometric platform MPS (M.P.S. Loran, KINETEC), where plantar pressure variables are provided in (Kgf / cm²) and plantar surface area (cm²) provided by BIOMECH STUDIO software.
Measured: 5 minutes
Balance
Modular baropodometric platform MPS (M.P.S. Loran, KINETEC), where distance of C.O.P are provide in (mm) and average speed in (mm / sec), provided by BIOMECH STUDIO software.
Measured: 5 minutes
Posture
Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
Measured: 1 hour
Gait
The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor
Measured: 10 minutes
Secondary outcomes (1)
Plantar Sensitivity
The tactile sensitivity will be evaluated in 4 plantar areas: medial forefoot, lateral forefoot, midfoot and hallux, using Semmes-Weinstein (10g) nylon monofilament (SORRI Bauru®).
Test tubes containing cold and hot water for thermal sensitivity assessment and a clinical tuning for evaluation of vibration sensitivity will also be used.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start10 May 2017
- Primary completion30 Mar 2018 (estimated)
- Study completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Control Group (CG) and the Trained Group (TG)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kelly Antunes e Silva Oliveira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kelly Antunes e Silva Oliveira, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390959
- Sponsor's protocol ID
- Proprioceptive DM2
- Other IDs
- Feedback N.2.052.913
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Proprioceptive Training on Plantar Pressure, Postural Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT03390959
- Acronym / sponsor ID
- Proprioceptive DM2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Proprioception, Diabetes Mellitus, Type 2, Postural Balance, Gait, Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Kelly Antunes e Silva OliveiraUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 5 Jan 2018 (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.
Introduction: Diabetes mellitus (DM) can be considered as one of the most important chronic diseases in the public health system, presenting a high cost for health services. Along with the increase in diagnosed cases of DM, there is a simultaneous increase in DM-related manifestations, such as peripheral diabetic neuropathy, diabetic foot ulcers and amputations. Decreased plantar sensitivity caused by microvascular complications, reduced sensation of vibration and loss of pressure sensitivity may be associated with recurrent falls due to reduced proprioceptive feedback. Although much is known about the beneficial results of physical exercise on glucose metabolism and insulin action, there are still few studies that evaluate the effects of different types of physical exercise, especially proprioceptive training, on plantar pressure, balance and posture of individuals.
Objective: The present study aims to evaluate the efficacy of proprioceptive training on plantar pressure, postural balance and posture in adults with Type 2 Diabetes Mellitus.
Methods: This study is a randomized, double blind, controlled clinical trial (evaluator and statistician) with individuals of both sexes, with type 2 diabetes mellitus diagnosed for at least 3 years, over 45 years of age, that can walk without assistance or supervision of others. Two groups will be formed, the Control Group (CG) and the Trained Group (TG), and the ideal "n" will be calculated in a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: Control Group (CG) and the Trained Group (TG)
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Training | Experimental | Other: Proprioceptive TrainingThe group participates in proprioceptive training that promotes sensory integration. |
| Control Group | Other | Other: Control GroupThe group continues in their daily lives with phone monitoring. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- individuals with type 2 diabetes mellitus, diagnosed for at least 3 years
- both genders
- aged 45 years or over
- able to wander without assistance or supervision from others
- absence of macroangiopathy
Key exclusion criteria (5 listed)
- presence of uncontrolled hypertension (systolic ≥ 200 mmHg and / or diastolic ≤100 mmHg);
- presence of a rheumatic condition that makes it impossible to perform the movements performed in the evaluation and in the therapeutic intervention;
- lack of more than 15% to the proprioceptive training program;
- individuals who perform some physical activity
- dependence on alcohol and illicit drugs
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 |
|---|---|---|
| Proprioceptive TrainingAlso: ExperimentalIndividuals in the Trained Group will perform the training twice a week for 45 minutes and perform for a period of 12 weeks. The training is divided into a pre-training phase where general hip dissociation exercises and simple stretching of the hip flexor and extensor muscle groups, knee, foot and paravertebral are performed. The second phase is the proprioceptive training, where it will involve training of balance, sensitivity and proprioception, being used a circuit composed of 15 stations, whose time of stay in each station is 2 minutes. And finally the third stage are relaxation exercises, performed with breathing exercises associated with slow active movements of the joints. | Other | Proprioceptive Training |
| Control GroupWill not be submitted to any physical intervention. It continues in your daily life with only phone monitoring. | Other | Control Group |
Primary outcome
Plantar Pressure
Time frame: 5 minutes
Modular baropodometric platform MPS (M.P.S. Loran, KINETEC), where plantar pressure variables are provided in (Kgf / cm²) and plantar surface area (cm²) provided by BIOMECH STUDIO software.
Balance
Time frame: 5 minutes
Modular baropodometric platform MPS (M.P.S. Loran, KINETEC), where distance of C.O.P are provide in (mm) and average speed in (mm / sec), provided by BIOMECH STUDIO software.
Posture
Time frame: 1 hour
Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
Gait
Time frame: 10 minutes
The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor
1 secondary outcome
Plantar Sensitivity
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Training in people with Diabetes Mellitus, Type 2, run by Kelly Antunes e Silva Oliveira 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 7 inclusion and 5 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 5 Jan 2018. 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 Maria das Graças Araujo, PhD (+558121268939, mgrodriguesaraujo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar Pressure (time frame: 5 minutes). 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?
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 5 Jan 2018.