Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
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|ClinicalTrials.gov Identifier: NCT03390959|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
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.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: Proprioceptive Training Other: Control Group|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two groups: Control Group (CG) and the Trained Group (TG)|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||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).|
|Official Title:||Effectiveness of Proprioceptive Training on Plantar Pressure, Postural Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2|
|Actual Study Start Date :||May 10, 2017|
|Estimated Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||March 30, 2018|
Experimental: Proprioceptive Training
The group participates in proprioceptive training that promotes sensory integration.
Other: Proprioceptive Training
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.
Other Name: Experimental
The group continues in their daily lives with phone monitoring.
Other: Control Group
Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
- 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
- Plantar Sensitivity [ Time Frame: 10 minutes ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390959
|Contact: Maria das Graças Araujo, PhDfirstname.lastname@example.org|
|Contact: Kelly Antunes e Silva Oliveira, email@example.com|
|Maria das Graças Araujo||Recruiting|
|Recife, Pernambuco, Brazil, 50670-901|