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Balance Training in Parkinson's Disease Using Cues

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ClinicalTrials.gov Identifier: NCT01960985
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Disturbance; Balance, Labyrinth Parkinson´s Disease Other: Physicaltherapy Phase 3

Detailed Description:

The objective of this work is 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 double blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.

Forty two patients with idiopathic PD will take part in this study, at stages 2 to 3 of the Hoehn and Yahr Classification (HY). They are randomly assigned into one of 3 groups: one group receiving motor training associated to external cues (ET), the other one group performing motor training only (MT) and a third group receiving no treatment just generalize orientations. Performance in gait and balance are assessement before and after 10 training sessions (two 45-minute sessions per week) for the ET and MT groups, and before and after 5 weeks for the CG, using the BERG test (BT), Postural Stress Test (PST), Time Up and Go (TUG). Patients are also assessment for independence in daily life activities and motor performance using section II and III of the Unified Parkinson's Disease Rating Scale (UPDRS); for Quality of Life using the Parkinson's Disease Quality of Life (PDQL), and for emotional state by Beck's Depression Inventory (BDI). The training consist on: the experimental group receiving the motor program to balance associated to rhythmical auditory cues. The directions of the training were I. self-perception (strategies - Verbal and visual guidance); II. motor performance (Speed variation, Range of motion, Trunk mobility, Turning, balance exercices); III. Attention Strategies (Division of attention between guidance, environment and yourself movement, Maintenance of attention during all sets); IV. Cues.

The training program consisted on 5 weeks with 45 minutes duration, divided in 05 minutes warm-up, 30 minutes main part, 10 minutes cool down. The control group (CG) wasn't training just received orientations. Each session will consist on 05 minutes Warm-Up including: Muscle stretching, joint movements, upper and lower global, movement slowly and using wide joint movement range, and turning. The Main Part including: Head movement (bending, rotation, and leaning sideways), Axial and proximal movements, coordinated movements with Upper and Lower range and speed, Functional reach, weight shifts, stationary and walking gait with rhythmic and speed variation, postural reactions, trunk rotation, Balance exercises. And the last part is the Cool Down, including: Slow walk, breathing exercises associated to Upper limb movements and global muscular relaxation and stretching.

During the study there aren't changes on patient's usual medicine. The subjects will be reassessment after 4 and 30 weeks without the program training.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficiency of Motor Training Program Associated With Extrenal Cues on the Balance of Patients With Parkinson's Disease.
Study Start Date : August 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physicaltherapy
Exprerimental group I - motor training balance training Exprerimental group II - motor training associated with visual and auditory cues on the balance training Control group - recived general orientations.
Other: Physicaltherapy
Other Name: balance training

Experimental: physiotherapy
Exprerimental group I - motor training balance training Exprerimental group II - motor training associated with visual and auditory cues on the balance training Control group - recived general orientations.
Other: Physicaltherapy
Other Name: balance training




Primary Outcome Measures :
  1. UPDRS [ Time Frame: up to 30 weeks ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease


Secondary Outcome Measures :
  1. Berg Balance Scale (BBS) Berg Balance Scale [ Time Frame: up to 30 weeks ]
    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.

  2. Dynamic Gait Index [ Time Frame: up to 30 weeks ]
    The scale assesses the ability to adapt the gait during motor tasks with different demands

  3. Retropulsion test [ Time Frame: up to 30 weeks ]
    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

  4. Timed Up and Go test (TUG) [ Time Frame: up to 30 weeks ]
    The Timed Up and Go test is a short, practical test by which gait and balance are tested

  5. Balance Evaluation Systems Test (BESTest) [ Time Frame: up to 30 weeks ]
    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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960985


Locations
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Brazil
University of Sao Paulo Clinical Hospital
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Tamine Capato, Master University of Sao Paulo HCFMUSP
Study Director: Maria Elisa Piemonte, PhG University of Sao Paulo

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01960985     History of Changes
Other Study ID Numbers: Tamine Capato 01
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: October 2013
Keywords provided by University of Sao Paulo General Hospital:
Balance, Postural
Parkinson´s Disease
H&Y 1-3
Exrecice
Postural adjustments
antecipatory postural
compensatory postural adjustments
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases