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

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

Sponsors

Lead Sponsor: University of Sao Paulo

Source University of Sao Paulo
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.

Overall Status Unknown status
Start Date May 2013
Completion Date December 2016
Primary Completion Date September 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Postural balance training diabetic type 2 four years
Secondary Outcome
Measure Time Frame
Quality of life of diabetics type 2 four years
Enrollment 50
Condition
Intervention

Intervention Type: Procedure

Intervention Name: sensorio-motor training

Other Name: quality of life

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

Gender: All

Minimum Age: 45 Years

Maximum Age: 64 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Ariane H.M Pletsch, PHD student

Phone: +551636020462

Phone Ext.: Brazil

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Rinaldo Roberto de Jesus Guirro Rinaldo Jesus Guirro, PHD +551636024584 [email protected] Ariane H M Pletsch, PHD Student Sub-Investigator
Location Countries

Brazil

Verification Date

May 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Sao Paulo

Investigator Full Name: Rinaldo Roberto de Jesus Guirro

Investigator Title: PHD Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: sensory-motor training

Type: Active Comparator

Description: Guidelines + sensory-motor training.Evaluation 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.

Label: guidelines

Type: Active Comparator

Description: receive the same guidelines and reviews that group orientation and training sensorineural engine and will be guided home exercises for postural twice a week 45 minutes for 12 weeks.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov