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Protocol: Balance Training in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Balance Training
Screening to prevent falls
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson´s disease, Physicaltherapy, Postural Balance, Gait, Rehabilitation

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All of the subjects will be diagnosed by neurologists from the Movement Disorders Ambulatory Clinic of the University of São Paulo Faculty of Medicine Clinics Hospital, according to the UK Brain Bank criteria [36] and should be at H&Y classification stage II or III, with a Mini Mental Status Examination (MMSE) [37] score of above 24.
  • All patients should also present fall history.
  • They should have the capacity to ambulate independently indoors without aid.

Exclusion Criteria:

  • These are the presence of neurological, orthopedic or cardiopulmonary problems, an unstable medication regime, and an inability to understand or adhere to the protocol because of, for example, cognitive, auditory or visual problems.
  • Patients receiving physical therapy training will also be excluded from the training.

Sites / Locations

  • University of Sao Paulo Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Motor training

Balance RhytmicalTraining

Arm Description

Balance training, Screening to prevent falls

Balance training, Screening to prevent falls

Outcomes

Primary Outcome Measures

Mini BESTest (MBESTest)
Clinical balance assessment tool that aims to target different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits.

Secondary Outcome Measures

Berg Balance Scale (BBS)
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.
UPDRS
The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease
Timed Up and Go test (TUG)
The Timed Up and Go test is a short, practical test by which gait and balance are tested
Push and Release 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
New Freezing of gait questonary (NFoG)
Questionay - measures of freezing of gait
Falls Efficacy Scale-International (FES-I)
The FES-I is a scale used to assessment the fear of falling.

Full Information

First Posted
May 21, 2015
Last Updated
November 1, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02488265
Brief Title
Protocol: Balance Training in Parkinson's Disease
Official Title
Randomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
December 20, 2017 (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
Postural instability is a particularly incapacitating disorder, where loss of motor independence by Parkinson´s Disease (PD) patients marks a significant stage of disease onset. Evidence suggests that deficits in automatic motor control, sensory integration and attention are associated with lack of balance in PD. Physiotherapy, together with medication, plays an important role in the treatment of this state, although no consensus has been reached on the best treatment modality. The aim of this randomized controlled trial protocol is to evaluate the effects of balance training with rhythmical (BRT), which is a motor program to improve balance associated with rhythmical auditory cues (RACs)
Detailed Description
A total of 150 PD patients at H&Y stages II-III and asymptomatic for depression and dementia are enrolled in a single-blind randomized study. Randomization is achieved via a computer-generated random-sequence table. All patients should also present a fall history.They will be assigned into one of three groups, and their balance and gait will be assessed before and after 10 training sessions, and after 4 and 30 weeks subsequent to the end of the training. Balance will be assess by Mini BESTest (MBESTest), BERG Test (BBS) and Postural Stress Test (PST). Gait will be evaluate by the Timed Up and Go test (TUG). Independence in Activities of Daily Living (ADLs) will be assess through interviews; and UPDRS, through motor performance. The BRT group received a motor program to improve balance associated with RACs, the MT group performed motor training with the same aims as those in the BRT group but without RACs, and the control group (CG) was trained only in orientations. The exercise program specific to balance is of 5 weeks' duration with two sessions per week, 45 minutes each, and consists of general physiotherapy exercises. Each session is divided into five warm-up minutes-30 minutes for the main part and 10 minutes for the cool down. The training progresses and intensifies each week depending on the individual's performance. The subjects should be able to execute 10 repetitions of the exercise sequences correctly to progress to the next movement. The training progressed and increased in intensity on each week. On the first week, before the training, each exercise was explained and demonstrated by the physiotherapist, who demanded special attention on the most difficult aspects of movement execution. The subjects performed 05 repetitions (5 RM) of each exercise. On the first phase the patients may present some mistakes and might need specific information to correct the movement that is on execution. The exercises will be repeat in the next sessions in order to consolidate learning. The subjects must have been capable of associating the corrections to the exercises that will proposs on the first week. In each group repetition, for both groups, the physiotherapist will use a verbal command before each movement change, anticipating it and requesting attention to the most difficult ones. Only the GBRT will be oriented to focus on the rhythmical auditory cues. On the second week, the subjects will perform a series of 10 repetitions (10 RM) and on the third week, 2 series of 10 repetitions (20RM). On the fourth week, subjects must have been able to execute 20RM of the exercise sequences with an increase in speed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson´s disease, Physicaltherapy, Postural Balance, Gait, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor training
Arm Type
Experimental
Arm Description
Balance training, Screening to prevent falls
Arm Title
Balance RhytmicalTraining
Arm Type
Experimental
Arm Description
Balance training, Screening to prevent falls
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).
Intervention Type
Other
Intervention Name(s)
Screening to prevent falls
Intervention Description
Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.
Primary Outcome Measure Information:
Title
Mini BESTest (MBESTest)
Description
Clinical balance assessment tool that aims to target different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits.
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
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
30 weeks
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
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
30 weeks
Title
Push and Release Test
Description
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
30 weeks
Title
New Freezing of gait questonary (NFoG)
Description
Questionay - measures of freezing of gait
Time Frame
30 weeks
Title
Falls Efficacy Scale-International (FES-I)
Description
The FES-I is a scale used to assessment the fear of falling.
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of the subjects will be diagnosed by neurologists from the Movement Disorders Ambulatory Clinic of the University of São Paulo Faculty of Medicine Clinics Hospital, according to the UK Brain Bank criteria [36] and should be at H&Y classification stage II or III, with a Mini Mental Status Examination (MMSE) [37] score of above 24. All patients should also present fall history. They should have the capacity to ambulate independently indoors without aid. Exclusion Criteria: These are the presence of neurological, orthopedic or cardiopulmonary problems, an unstable medication regime, and an inability to understand or adhere to the protocol because of, for example, cognitive, auditory or visual problems. Patients receiving physical therapy training will also be excluded from the training.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisa P Piemonte, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tamine TC Capato, Master
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo Clinical Hospital
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32737973
Citation
Capato TTC, de Vries NM, IntHout J, Ramjith J, Barbosa ER, Nonnekes J, Bloem BR. Multimodal Balance Training Supported by Rhythmic Auditory Stimuli in Parkinson Disease: Effects in Freezers and Nonfreezers. Phys Ther. 2020 Oct 30;100(11):2023-2034. doi: 10.1093/ptj/pzaa146.
Results Reference
derived
PubMed Identifier
26347052
Citation
Capato TT, Tornai J, Avila P, Barbosa ER, Piemonte ME. Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease. BMC Neurol. 2015 Sep 7;15:162. doi: 10.1186/s12883-015-0418-x.
Results Reference
derived

Learn more about this trial

Protocol: Balance Training in Parkinson's Disease

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