Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Fall Index
研究概览
简要总结
Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality.
The purpose of this study was to explore whether an at-home based Rhythmic Auditory Stimulation (RAS) gait training program will decrease the number of falls in persons with PD with a history of falling. We also evaluated changes in clinical and kinematic parameters used to assess fall risk in this population.
Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months, were randomly allocated into two groups. The experimental group trained daily with RAS for 24 weeks. The control group also trained daily with RAS, but discontinued training between weeks 8 and 16. During treatment patients walked for 30 minutes in a home based environment with metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at baseline, weeks 8, 16, and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Home training instructions were provided by a certified physical therapist and board-certified neurologic music therapist blinded to treatment allocation of the subjects.
The TUG and the BBS were administered by an experienced physical therapist blinded to the study design.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hoehn & Yahr (HY) stage III or IV
- •At least 2 falls in the past 12 months
- •Stable antiparkinsonian medication regime
- •Ability to ambulate independently for at least 50 m.
排除标准
- •Other neurological or orthopedic conditions
- •Medically diagnosed hearing loss
- •Dementia (Mini Mental Status Exam score < 24).
研究组 & 干预措施
Continuous RAS
The experimental group (continuous treatment) trained daily with RAS for 24 weeks.
干预措施: Rhythmic Auditory Stimulation (RAS) (Other)
Intermittent RAS
The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks.
干预措施: Rhythmic Auditory Stimulation (RAS) (Other)
结局指标
主要结局
Fall Index
时间窗: Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.
The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.
次要结局
- Falls Efficacy Scale (FES)(Change in level of concern about falling from baseline assessed by Fear of the Falling Questionnaire/Short FES-1 at 8 weeks, 16 weeks, and 24 weeks.)
- Berg Balance Scale (BBS)(Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.)
- Timed Up and Go (TUG)(Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.)
- Gait(Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.)
研究者
Michael H. Thaut
Professor
University of Toronto