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临床试验/NCT03336307
NCT03336307已完成不适用

Predictors of Gait Improvement in Patients With Parkinson's Disease After Rehabilitation

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
walking speed (change)

研究概览

简要总结

Patients with Parkinson's disease show a gait disturbance which is considered as one of the most disabling aspect of the disease that strongly impacts on patients' autonomy and quality of life. The mechanism underlying gait impairment is multi-factorial, reflects the global motor impairment of patients with PD and is mainly related to a neurotransmitter deficiency inducing bradykinesia, rigidity, abnormal trunk control and postural instability. For this reason, and considering the impact of social and economic costs, one of the main foci of intervention in patients with PD should be treating gait abnormalities. This need is further reinforced by the knowledge that gait outcomes are correlated with longevity, cognitive decline and adverse events.

Besides the shorten-step gait clinical description of the gait disorder in PD, in the last years, studies using modern 3D motion analysis systems have further detailed the gait pattern in PD disclosing abnormalities in cadence, stance duration, swing duration, double support duration, leg length, step length, velocity, hip, knee and ankle ROMs. Such abnormal gait parameters seem to correlate with the clinical outcomes of UPDRS score, H-Y stage and milliequivalents of levodopa taken. Importantly, gait parameters can either normalize or improve after several rehabilitative treatment strategies including physiotherapy, assistive equipment, sensory cueing, treadmill training, physical activity, home base exercises. However, none of the previous studies specifically investigated which biomechanical factor can be modified after rehabilitation and which clinical characteristic can predict the rehabilitation-induced gait improvement. This would be extremely important to typifying, grouping and selecting patients, optimizing the rehabilitative strategies and cost management.

The aims of the present study were to evaluate in a sample of patients with PD: i) which gait parameters can be modified after a short-term rehabilitation program; ii) which, if any, clinical variable can predict the improvement of the gait function after rehabilitation. At this aim we quantitatively evaluated the gait performance of PD patients by means of a 3-D motion analysis system.

详细描述

Fifty out of 67 patients with idiopathic PD assessed for eligibility were recruited at Rehabilitation Unit of Department of Medical and Surgical Sciences and Biotechnologies, University of Rome, Sapienza, and at Rehabilitation Unit of Policlinico Italia Centre, Rome, Italy. Patients were admitted for outpatient rehabilitation between May 2014 and April 2017. The inclusion criteria were a diagnosis of idiopathic PD according to UK bank criteria and Hoehn and Yahr stages 1 to 3. All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks. Exclusion criteria were: cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]), moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]), and orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.

All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase.

Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.

The study complied with the Helsinki Declaration and received local ethics committee approval. Prior to taking part in the study, all the participants gave a written consent after a fully explanation of the experimental procedure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
48 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic PD according to UK bank criteria
  • Hoehn and Yahr stages 1 to
  • All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks

排除标准

  • Cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]),
  • moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]), -. orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.

结局指标

主要结局

walking speed (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

distance coverde by the body in unit of time

Trunk saggital plane (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

step length (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

the distance measured from the heel print of one foot to the heel print of the other foot

The flexion-extension hips (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

Trunk frotal plane (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

stance duration (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

time interval between two consecutive foot strikes of the same lower limb) expressed as a percentage of the stride duration

Step width (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

Step width variability discriminates gait of healthy young and older adults during treadmill locomotion.

cadence (change)

时间窗: - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

time of steps per unit time

次要结局

  • Unified Parkinson's Disease Rating Scale UPDRS Severity of parkinsonism(- T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments)
  • Modified Hoehn and Yahr staging(- T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariano Serrao

Clinical Professor

University of Roma La Sapienza

研究点 (1)

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