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临床试验/NCT04608604
NCT04608604已完成不适用

Mobility in Atypical Parkinsonism: a Randomized Trial of Physiotherapy

Victoria Sidoroff1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Sensor-based analysis

研究概览

简要总结

Patients with atypical parkinsonism often show gait and mobility impairment manifesting in early disease stages.

In order to maintain mobility and physical autonomy as long as possible for these patients, we will examine the effect of two types of physiotherapy in patients with multiple system atrophy (MSA), progressive supranuclear gaze palsy (PSP) and idiopathic Parkinson's disease (IPD).

The study is divided into an ambulant daily in-patient physiotherapy phase, followed by a home-based training phase. At the beginning and the end of the study, the patients daily activity will be recorded for one week using Physical Activity Monitoring (PAM) sensors.

The aim of this double-blind, randomized-controlled study is to determine effective physiotherapy in patients with atypical parkinsonian syndromes in order to maintain mobility for as long as possible.

详细描述

Patients with Parkinson's disease often show gait impairment and reduced mobility over the disease course. Rare atypical forms of parkinsonism, like multiple system atrophy (MSA) or progressive supranuclear gaze palsy (PSP) develop these features in early disease stages. The reduced mobility and increased time spent in sitting or lying posture leads to loss of physical independence and increased mortality. Since MSA and PSP can currently only be treated symptomatically, a long lasting independence and mobility is therefore of great importance.

A positive effect has already been shown in a few studies on specific physiotherapy in patients with idiopathic Parkinson's disease (IPD), and some small studies also give us an evidence that physiotherapy in atypical parkinsonism can improve mobility.

The Mobility_APP study examines the effect of two types of physiotherapy in patients with MSA, PSP and IPD. The participants are initially assigned to a type of therapy and they learn specific exercises with a physiotherapist every day for two weeks. These exercises will then be continued independently at home for another five weeks. Regular checks in the study center ensure a precise examination of the physical condition, quality of life and gait pattern. The latter will be objectively analyzed with the help of sensors that are worn on the participant's shoes. In addition, before the start and at the end of the study, the participants are also monitored for one week at home using shoe sensors in order to reflect the natural conditions of the patients.

During the entire study, neither the participant nor the study investigator knows what type of therapy is being used in order to guarantee an unbiased analysis (double blinding).

The aim of this double-blind, randomized-controlled study is to determine effective physiotherapy in patients with atypical parkinsonian syndromes in order to maintain mobility for as long as possible. If the exercises learned during physiotherapy can be continued regularly at home and can improve mobility, this means a big step towards autonomous therapy. Frequent visits to therapists can be reduced and sufficient and effective independent therapy can still be carried out during times of crisis or phases with increased motor impairment.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •The subject is willing and able to give written informed consent
  • •The patient is able to tolerate all study visits including daily physiotherapy and home training.
  • •Patients similar with regard to age and sex with probable/possible MSA-P according to rev. Gilman criteria OR probable/possible PSP-RS according to MDS-PSP criteria OR PD according to MDS-PD criteria.
  • •Stable antiparkinsonian and Anti-OH medication 4 weeks prior to study entry.

排除标准

  • •Co-morbidities that influence the clinical presentation of parkinsonian symptoms (as judged by the enrolling investigator).
  • •Participation in other clinical trials that might influence the impact of the trial intervention (as judged by the enrolling investigator)
  • •H&Y Staging score greater than or equal to 4
  • •Change of antiparkinsonian and anti-OH medication 4 weeks prior to the interventional trial.
  • •Secondary cause of autonomic failure or parkinsonism (e.g. diabetic autonomic neuropathy, bladder surgery, drug-induced or vascular parkinsonism, etc.)
  • •Dementia according to DSM-V.

研究组 & 干预措施

Physiotherapy 1

Active Comparator

干预措施: Physiotherapy (Other)

Physiotherapy 2

Active Comparator

干预措施: Physiotherapy (Other)

结局指标

主要结局

Sensor-based analysis

时间窗: Baseline to week 7

Gait speed

次要结局

  • Clinical Rating scale(Baseline to week 7)
  • Sensor-based analysis(Baseline to week 7)
  • PAM Secondary outcome(Baseline to week 7)

研究者

发起方
Victoria Sidoroff
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Victoria Sidoroff

Study Investigator, Department of Neurology, Medical University of Innsbruck

Universitätsklinik für Neurologie, Innsbruck

研究点 (1)

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