Balance Training in Parkinson's Disease Using Cues
Primary Purpose
Disturbance; Balance, Labyrinth, Parkinson´s Disease
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Physicaltherapy
Sponsored by
About this trial
This is an interventional treatment trial for Disturbance; Balance, Labyrinth focused on measuring Balance, Postural, Parkinson´s Disease, H&Y 1-3, Exrecice, Postural adjustments, antecipatory postural, compensatory postural adjustments
Eligibility Criteria
Inclusion Criteria:
- Elderly
- The patient is able to provide informed consent.
- Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist
- Hoehn and Yahr Stage 1-3
- Able to ambulate without an assistive device
- On stable doses of Parkinson's medications prior to study onset
Exclusion Criteria:
- Mini Mental Status Exam (MMSE) < 24
- Change in Parkinson's medications in the duration of study
- Uncontrolled orthostasis
- Symptomatic coronary artery disease
- Fracture of lower limb prior to study onset
- Other neurologic diagnosis
- Physical therapy before and during to study duration
- Significant camptocormia
- Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.
Sites / Locations
- University of Sao Paulo Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Physicaltherapy
physiotherapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
UPDRS
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
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.
Dynamic Gait Index
The scale assesses the ability to adapt the gait during motor tasks with different demands
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
Timed Up and Go test (TUG)
The Timed Up and Go test is a short, practical test by which gait and balance are tested
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.
Full Information
NCT ID
NCT01960985
First Posted
August 30, 2013
Last Updated
June 29, 2015
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01960985
Brief Title
Balance Training in Parkinson's Disease Using Cues
Official Title
Efficiency of Motor Training Program Associated With Extrenal Cues on the Balance of Patients With Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disturbance; Balance, Labyrinth, Parkinson´s Disease
Keywords
Balance, Postural, Parkinson´s Disease, H&Y 1-3, Exrecice, Postural adjustments, antecipatory postural, compensatory postural adjustments
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physicaltherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
physiotherapy
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Physicaltherapy
Other Intervention Name(s)
balance training
Primary Outcome Measure Information:
Title
UPDRS
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease
Time Frame
up to 30 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS) Berg Balance Scale
Description
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.
Time Frame
up to 30 weeks
Title
Dynamic Gait Index
Description
The scale assesses the ability to adapt the gait during motor tasks with different demands
Time Frame
up to 30 weeks
Title
Retropulsion test
Description
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
Time Frame
up to 30 weeks
Title
Timed Up and Go test (TUG)
Description
The Timed Up and Go test is a short, practical test by which gait and balance are tested
Time Frame
up to 30 weeks
Title
Balance Evaluation Systems Test (BESTest)
Description
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.
Time Frame
up to 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Elderly
The patient is able to provide informed consent.
Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist
Hoehn and Yahr Stage 1-3
Able to ambulate without an assistive device
On stable doses of Parkinson's medications prior to study onset
Exclusion Criteria:
Mini Mental Status Exam (MMSE) < 24
Change in Parkinson's medications in the duration of study
Uncontrolled orthostasis
Symptomatic coronary artery disease
Fracture of lower limb prior to study onset
Other neurologic diagnosis
Physical therapy before and during to study duration
Significant camptocormia
Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamine Capato, Master
Organizational Affiliation
University of Sao Paulo HCFMUSP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Elisa Piemonte, PhG
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of Sao Paulo Clinical Hospital
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
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Balance Training in Parkinson's Disease Using Cues
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