We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03390959
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Information provided by (Responsible Party):
Kelly Antunes e Silva Oliveira, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: Proprioceptive Training Other: Control Group

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
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).
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Control Group
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Posture [ Time Frame: 1 hour ]
    Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)

  4. Gait [ Time Frame: 10 minutes ]
    The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390959

Contact: Maria das Graças Araujo, PhD +558121268939 mgrodriguesaraujo@hotmail.com
Contact: Kelly Antunes e Silva Oliveira, bachelor +5583998346441 kelly.antunes@gmail.com

Maria das Graças Araujo Recruiting
Recife, Pernambuco, Brazil, 50670-901
Sponsors and Collaborators
Kelly Antunes e Silva Oliveira

Responsible Party: Kelly Antunes e Silva Oliveira, Bachelor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03390959     History of Changes
Other Study ID Numbers: Proprioceptive DM2
Feedback N.2.052.913 ( Other Identifier: UFPE CAAE N. 61248216.2.0000.5208 )
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Antunes e Silva Oliveira, Universidade Federal de Pernambuco:
Diabetes Mellitus, Type 2
Postural Balance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases