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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Control Group; Other: Proprioceptive Training

• Registration Number: NCT03390959
• Lead Sponsor: Kelly Antunes e Silva Oliveira

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-10
• Status Verified: 2017-12
• Study First Submitted: 2017-12-28
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	The group continues in their daily lives with phone monitoring.
Proprioceptive Training	Proprioceptive Training	The group participates in proprioceptive training that promotes sensory integration.

Primary Outcome Measures

Name	Time	Method
Balance	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	1 hour	Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
Gait	10 minutes	The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor
Plantar Pressure	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.

Secondary Outcome Measures

Name	Time	Method
Plantar Sensitivity	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.

Trial Locations

Locations (1)

Maria das Graças Araujo; 🇧🇷 Recife, Pernambuco, Brazil