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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

Tracking Information
First Submitted Date  ICMJE August 30, 2013
First Posted Date  ICMJE October 11, 2013
Last Update Posted Date June 30, 2015
Study Start Date  ICMJE August 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01960985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • 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.
  • Dynamic Gait Index [ Time Frame: up to 30 weeks ]
    The scale assesses the ability to adapt the gait during motor tasks with different demands
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Balance Training in Parkinson's Disease Using Cues
Official Title  ICMJE Efficiency of Motor Training Program Associated With Extrenal Cues on the Balance of Patients With Parkinson's Disease.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Disturbance; Balance, Labyrinth
  • Parkinson´s Disease
Intervention  ICMJE Other: Physicaltherapy
Other Name: balance training
Study Arms  ICMJE
  • 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.
    Intervention: Other: Physicaltherapy
  • 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.
    Intervention: Other: Physicaltherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2013)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960985
Other Study ID Numbers  ICMJE Tamine Capato 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tamine Capato, Master University of Sao Paulo HCFMUSP
Study Director: Maria Elisa Piemonte, PhG University of Sao Paulo
PRS Account University of Sao Paulo General Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP