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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01861392
• Other study ID #: U1111-1143-3618
• Status: Not yet recruiting
• Phase: N/A
• First received: May 21, 2013
• Last updated: May 22, 2013
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: Ariane H.M Pletsch, PHD student
• Phone: +551636020462
• Email: ariane_mansano[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Exercise Therapy
• Postural Balance
• Quality of Life

Intervention

Procedure:
• sensorio-motor training

Locations

Country	Name	City	State
Brazil	Rinaldo Roberto de Jesus Guirro	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Song CH, Petrofsky JS, Lee SW, Lee KJ, Yim JE. Effects of an exercise program on balance and trunk proprioception in older adults with diabetic neuropathies. Diabetes Technol Ther. 2011 Aug;13(8):803-11. doi: 10.1089/dia.2011.0036. Epub 2011 May 11. — View Citation

Suprak DN. Shoulder joint position sense is not enhanced at end range in an unconstrained task. Hum Mov Sci. 2011 Jun;30(3):424-35. doi: 10.1016/j.humov.2011.02.003. Epub 2011 Mar 27. — View Citation

Vandekerckhove M, Vermeire E, Weeren A, Van Royen P. Validation of the Diabetes Obstacles Questionnaire (DOQ) to assess obstacles in living with type 2 diabetes in a Belgian population. Prim Care Diabetes. 2009 Feb;3(1):43-7. doi: 10.1016/j.pcd.2009.02.003. Epub 2009 Mar 4. — View Citation

Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural balance training diabetic type 2		four years	Yes
Secondary	Quality of life of diabetics type 2		four years	No

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