Factors Associated with Falling in Parkinson's Disease: a Multidisciplinary Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Fall events
研究概览
简要总结
The objective of this study will be to identify multidisciplinary fall risk factors in persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy adults. Both the relative contribution of each independent factor, as well as the interaction between these factors, will be examined. The study will include multidisciplinary assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's Disease group
- •Inclusion criteria:
- •Persons with idiopathic PD diagnosed by a medical doctor according to the United Kingdom PD Brain Bank Criteria
- •Aged between 18 and 75 years-old
- •Stage 3 on the Hoehn and Yahr scale in the on-medication state
- •On a stable dose of PD medication (at least one week)
- •Able to stand and walk on a treadmill without support for at least 3 minutes
- •Able to give consent
排除标准
- •Atypical parkinsonism
- •Unpredictable symptom fluctuations
- •Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
- •Duodopa pump therapy
- •Dementia (Montreal Cognitive Assessment (MoCA) < 21)[1]
- •Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
- •Concurrent neurological disorders (e.g. stroke)
- •Comorbidities that affect gait or balance (e.g. peripheral neuropathy)
- •Acute illness
- •Epilepsy or history of seizures
- •Depression (MDS-UPDRS item 1.3 ≥ 2)
- •Body weight over 120 kilograms
- •Pregnancy
- •Participation in other ongoing experimental trials
- •Healthy control group
- •Inclusion criteria:
- •Age and sex-matched healthy adults
- •Exclusion criteria:
- •Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
- •Body weight over 120 kilograms
- •Pregnancy
- •Participation in other ongoing experimental trials
研究组 & 干预措施
Parkinson's Disease group
Patients with stage 3 idiopathic Parkinson's Disease
干预措施: Baseline assessment of demographic, anthropometric and clinical characteristics (Other)
Parkinson's Disease group
Patients with stage 3 idiopathic Parkinson's Disease
干预措施: Locomotor assessments (Other)
Parkinson's Disease group
Patients with stage 3 idiopathic Parkinson's Disease
干预措施: Speech assessments (Other)
Parkinson's Disease group
Patients with stage 3 idiopathic Parkinson's Disease
干预措施: Audiology assessments (Other)
Healthy control group
Age and sex-matched healthy adults
干预措施: Locomotor assessments (Other)
Healthy control group
Age and sex-matched healthy adults
干预措施: Speech assessments (Other)
Healthy control group
Age and sex-matched healthy adults
干预措施: Baseline assessment of demographic, anthropometric and clinical characteristics (Other)
Healthy control group
Age and sex-matched healthy adults
干预措施: Audiology assessments (Other)
结局指标
主要结局
Fall events
时间窗: baseline to 6 months after baseline
Number of accidental falls documented using a daily fall diary with monthly telephone follow-ups.
次要结局
- Static visual acuity(baseline)
- Spontaneous speech production(baseline; baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Otoacoustic Emissions Test(baseline)
- Walking cadence(baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Step length(baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Otoscopy(baseline)
- Tympanometry(baseline)
- Walking speed(baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Hip, knee and ankle joint angle during walking(baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Hip, knee and ankle joint moment during walking(baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Hip, knee and ankle joint power during walking(baseline during 3 min self-paced treadmill walking; baseline during 3 min self-paced treadmill walking while answering semi-standardized questions; baseline during 3 min self-paced treadmill walking while describing a virtual environment)
- Freezing of gait(baseline during 6 min self-paced treadmill walking in a virtual environment)
- Pure tone audiometry(baseline)
- Speech Handicap Index(baseline)
- Video Head Impuls Test(baseline)
- Ocular Motor Testing(baseline)
- Dix-Hallpike Test(baseline)
- Dizziness Handicap Inventory(baseline)
- Ocular Vestibular Evoked Myogenic Potential Testing(baseline)
- Dynamic visual acuity(baseline)
- Cervical Vestibular Evoked Myogenic Potential Testing(baseline)
- Roll Test(baseline)