Protocol: Balance Training in Parkinson's Disease
Randomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's Disease
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sao Paulo、巴西
- University of Sao Paulo Clinical Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Motor training
Balance training, Screening to prevent falls
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Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).
Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.
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实验性的:Balance RhytmicalTraining
Balance training, Screening to prevent falls
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Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).
Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mini BESTest (MBESTest)
大体时间:30 weeks
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Clinical balance assessment tool that aims to target different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits.
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30 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Berg Balance Scale (BBS)
大体时间:30 weeks
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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.
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30 weeks
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UPDRS
大体时间:30 weeks
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The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease
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30 weeks
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Timed Up and Go test (TUG)
大体时间:30 weeks
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The Timed Up and Go test is a short, practical test by which gait and balance are tested
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30 weeks
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Push and Release Test
大体时间:30 weeks
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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
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30 weeks
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New Freezing of gait questonary (NFoG)
大体时间:30 weeks
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Questionay - measures of freezing of gait
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30 weeks
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Falls Efficacy Scale-International (FES-I)
大体时间:30 weeks
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The FES-I is a scale used to assessment the fear of falling.
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30 weeks
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合作者和调查者
调查人员
- 研究主任:Maria Elisa P Piemonte, PhD、University of Sao Paulo
- 首席研究员:Tamine TC Capato, Master、University of Sao Paulo
出版物和有用的链接
一般刊物
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Balance Training的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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Southern Methodist UniversityKing's College London完全的
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Kyungpook National University HospitalMinistry of Health & Welfare, Korea; Fresenius Medical Care Korea完全的
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Sahmyook University完全的
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BioSCIENCE GmbHHeiMed完全的
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Glostrup University Hospital, Copenhagen未知