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Clinical Trials/NCT01861392
NCT01861392
Unknown
Not Applicable

Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial

University of Sao Paulo1 site in 1 country50 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
University of Sao Paulo
Enrollment
50
Locations
1
Primary Endpoint
Postural balance training diabetic type 2
Last Updated
12 years ago

Overview

Brief Summary

Background: The individual's ability to sustain itself in the upright position, effectively adjusting the body's movements and reacting to external stimuli, postural control strategies represent essential activities of daily living. Diabetes mellitus type 2 (DM-2) is considered a more problem of Public Health as having complications deficit in functional performance of the lower limbs and falls, which can interfere with the maintenance of balance, and is a strong predictor of functional limitations self referred. Aim: To assess quality of life and the answers neuromuscular balance and baropodometric after sensory-motor training in patients with type 2 diabetes. Method: To be recruited 50 volunteers aged between 45 to 64 years with DM-2, of both sexes, divided into two groups: 1) Guidelines and 2) Guidelines + sensory-motor training. Biomechanical data will be collected (balance, baropodometry, electromyography strength and joint position sense), as well as questionnaires ADDQoL and BESTest. The intervention will be twice a week for 45 minutes for 12 weeks, divided into three phases: heating, sensory-motor training and cool-down, with monitoring of blood pressure and blood glucose. There will be a follow up after 3 months of intervention. Statistical analysis will be used normality test to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and adopted a significance level of 5%. Expected Results: Considering previous studies that demonstrate improvement in postural balance static and dynamic responses under the forward training protocol sensorimotor disease Diabetes mellitus type 2, is expected to improve neuromuscular, balance, distribution plant, the joint position sense and the quality of life of voluntary DM-2.

Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus, quality of life.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2016
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rinaldo Roberto de Jesus Guirro

PHD Professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of diabetes mellitus type 2 with controlled blood glucose
  • Absence of skin lesions or fractures of the lower limbs in the last 6 months -Plantar malformations
  • Severe postural abnormalities and limb length difference.

Exclusion Criteria

  • Use of medications that can have negative effects on the function of cognition, attention and psychomotor (ie, opioids, antiepileptics, anxiolytics, antipsychotics, hypnotics and sedatives)
  • Diagnosis of cardiovascular, neurological, rheumatological and musculoskeletal disorders that may interfere with activities of daily living
  • Presence of vestibular disorders

Outcomes

Primary Outcomes

Postural balance training diabetic type 2

Time Frame: four years

Secondary Outcomes

  • Quality of life of diabetics type 2(four years)

Study Sites (1)

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