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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Proprioceptive Training
Control Group
Sponsored by
Kelly Antunes e Silva Oliveira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Proprioception, Diabetes Mellitus, Type 2, Postural Balance, Gait, Posture

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maria das Graças AraujoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Proprioceptive Training

Control Group

Arm Description

The group participates in proprioceptive training that promotes sensory integration.

The group continues in their daily lives with phone monitoring.

Outcomes

Primary Outcome Measures

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.
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.
Posture
Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
Gait
The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor

Secondary Outcome Measures

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.

Full Information

First Posted
December 28, 2017
Last Updated
December 28, 2017
Sponsor
Kelly Antunes e Silva Oliveira
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1. Study Identification

Unique Protocol Identification Number
NCT03390959
Brief Title
Effectiveness of Proprioceptive Training on Plantar Pressure, Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
Official Title
Effectiveness of Proprioceptive Training on Plantar Pressure, Postural Balance, Posture and Gait in Individuals With Diabetes Mellitus Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Anticipated)
Study Completion Date
March 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kelly Antunes e Silva Oliveira

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Proprioception, Diabetes Mellitus, Type 2, Postural Balance, Gait, Posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: Control Group (CG) and the Trained Group (TG)
Masking
InvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive Training
Arm Type
Experimental
Arm Description
The group participates in proprioceptive training that promotes sensory integration.
Arm Title
Control Group
Arm Type
Other
Arm Description
The group continues in their daily lives with phone monitoring.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Training
Other Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
Primary Outcome Measure Information:
Title
Plantar Pressure
Description
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.
Time Frame
5 minutes
Title
Balance
Description
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.
Time Frame
5 minutes
Title
Posture
Description
Optoelectronic system (SMART DX100, produced by BTS Bioengineering, Milan, Italy)
Time Frame
1 hour
Title
Gait
Description
The Time Up And Go Test (TUG) was performed using the Wiva® Science sensor KINETEC® type inertial sensor
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Plantar Sensitivity
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria das Graças Araujo, PhD
Phone
+558121268939
Email
mgrodriguesaraujo@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Antunes e Silva Oliveira, bachelor
Phone
+5583998346441
Email
kelly.antunes@gmail.com
Facility Information:
Facility Name
Maria das Graças Araujo
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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