Parkinson´s Disease Clinical Trial
Official title:
Efficiency of Motor Training Program Associated With Extrenal Cues on the Balance of Patients With Parkinson's Disease.
Verified date | October 2013 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
Verifying the efficiency of motor training associated with visual and auditory cues on the balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Status | Completed |
Enrollment | 42 |
Est. completion date | August 2012 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Elderly 2. The patient is able to provide informed consent. 3. Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist 4. Hoehn and Yahr Stage 1-3 5. Able to ambulate without an assistive device 6. On stable doses of Parkinson's medications prior to study onset Exclusion Criteria: 1. Mini Mental Status Exam (MMSE) < 24 2. Change in Parkinson's medications in the duration of study 3. Uncontrolled orthostasis 4. Symptomatic coronary artery disease 5. Fracture of lower limb prior to study onset 6. Other neurologic diagnosis 7. Physical therapy before and during to study duration 8. Significant camptocormia 9. Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo Clinical Hospital | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | UPDRS | The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease | up to 30 weeks | No |
Secondary | Berg Balance Scale (BBS) Berg Balance Scale | Berg Balance Scale assesses the functional balance of patients with Parkinson´s disease. It is a clinic assessment of patient that evaluate the antecipatory postural adjustments and the performance of patient to stand up and sit down, turn on and step, among others situations. | up to 30 weeks | No |
Secondary | Dynamic Gait Index | The scale assesses the ability to adapt the gait during motor tasks with different demands | up to 30 weeks | No |
Secondary | Retropulsion test | The Retropulsion test, by which an unexpected, quick and firm jerk on the shoulder is given in a backward direction.It is a clinic assessment of patient that evaluate the compensatory postural adjustments | up to 30 weeks | No |
Secondary | Timed Up and Go test (TUG) | The Timed Up and Go test is a short, practical test by which gait and balance are tested | up to 30 weeks | No |
Secondary | Balance Evaluation Systems Test (BESTest) | Clinical balance assessment tool that aims to target 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits. | up to 30 weeks | No |
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