Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
2 other identifiers
interventional
14
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started May 2017
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2017
CompletedFirst Submitted
Initial submission to the registry
December 28, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedJanuary 5, 2018
December 1, 2017
11 months
December 28, 2017
December 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
5 minutes
Posture
Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
1 hour
Gait
The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor
10 minutes
Secondary Outcomes (1)
Plantar Sensitivity
10 minutes
Study Arms (2)
Proprioceptive Training
EXPERIMENTALThe group participates in proprioceptive training that promotes sensory integration.
Control Group
OTHERThe group continues in their daily lives with phone monitoring.
Interventions
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.
Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria das Graças Araujo
Recife, Pernambuco, 50670-901, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double (Investigator, Outcomes Assessor) The one who assess the patients in the beginning and in the final moment (investigator) not know in what group the patient is. As the investigator that will do the statistic (outcome assessor).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Bachelor
Study Record Dates
First Submitted
December 28, 2017
First Posted
January 5, 2018
Study Start
May 10, 2017
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
January 5, 2018
Record last verified: 2017-12