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Protocol: Balance Training in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02488265
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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)

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Balance Training Other: Screening to prevent falls Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's Disease
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motor training
Balance training, Screening to prevent falls
Other: Balance Training
Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).

Other: Screening to prevent falls
Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.

Experimental: Balance RhytmicalTraining
Balance training, Screening to prevent falls
Other: Balance Training
Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).

Other: Screening to prevent falls
Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.




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

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

  4. Push and Release Test [ Time Frame: 30 weeks ]
    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

  5. New Freezing of gait questonary (NFoG) [ Time Frame: 30 weeks ]
    Questionay - measures of freezing of gait

  6. Falls Efficacy Scale-International (FES-I) [ Time Frame: 30 weeks ]
    The FES-I is a scale used to assessment the fear of falling.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02488265


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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Study Director: Maria Elisa P Piemonte, PhD University of São Paulo
Principal Investigator: Tamine TC Capato, Master University of São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02488265     History of Changes
Other Study ID Numbers: Tamine Capato 02
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Keywords provided by University of Sao Paulo General Hospital:
Parkinson´s disease
Physicaltherapy
Postural Balance
Gait
Rehabilitation
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