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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01861392
Other study ID # U1111-1143-3618
Secondary ID
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


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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