Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-27 @ 7:54 AM
Study NCT ID:
NCT01861392
Status:
UNKNOWN
Last Update Posted:
2013-05-23
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial
Sponsor:
University of Sao Paulo
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Keywords: physical therapy modalities, exercise therapy, postural balance, Diabetes Mellitus, quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: