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Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608604
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : May 12, 2023
Sponsor:
Collaborators:
University of Erlangen-Nürnberg, Germany
University Hospital Erlangen, Germany
Ecole Polytechnique Fédérale de Lausanne, Switzerland
University of Lausanne Hospital, Switzerland
Medical University Innsbruck
University of Luxembourg, Luxembourg
Hospital of Bolzani, Italy
Information provided by (Responsible Party):
Gregor Wenning, Universitätsklinik für Neurologie, Innsbruck

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple System Atrophy, Parkinson Variant (Disorder) Parkinson Disease Progressive Supranuclear Palsy Other: Physiotherapy Not Applicable

Detailed Description:

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.

The project is kindly supported by the Fund for the Promotion of Scientific Research (FWF). Together with the German Research Foundation (DFG) and Swiss National Science Foundation (SNF) in Switzerland this project can be carried out internationally in cooperation with renowned centers for neurological and sensor-based research.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Mobility in Atypical Parkinsonism: a Randomized Trial of Physiotherapy
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : November 1, 2024


Arm Intervention/treatment
Active Comparator: Physiotherapy 1 Other: Physiotherapy
Patients will be randomized in either physiotherapy 1 or physiotherapy 2. Physiotherapy programs are individually tailored based on a structured standardized series. In order to not unblind potential participants, detailed description of both interventions will be provided after recruitment has been finished.

Active Comparator: Physiotherapy 2 Other: Physiotherapy
Patients will be randomized in either physiotherapy 1 or physiotherapy 2. Physiotherapy programs are individually tailored based on a structured standardized series. In order to not unblind potential participants, detailed description of both interventions will be provided after recruitment has been finished.




Primary Outcome Measures :
  1. Sensor-based analysis [ Time Frame: Screening/Baseline to week 7 ]
    To investigate whether Physiotherapy 1 versus Physiotherapy 2 and home-based exercise lead to significantly greater improvement of lab and home-based gait parameters (gait velocity, stride length, stride time, swing time, stance time, heel strike angle and maximal toe clearance measures will be aggregated to one report value) in patients with PD, MSA-P and PSP-RS.


Secondary Outcome Measures :
  1. Clinical Rating scales [ Time Frame: Screening/Baseline to week 7 ]
    To evaluate the effects of Physiotherapy 1 versus Physiotherapy 2 on motor symptoms and on different domains of patients with MSA-P, PD, and PSP-RS by means of the patients ́ questionnaires (MoCA, Frontal Assessment Battery, International Physical Activity Questionnaire, Orthostatic Hypotension Questionnaire, 8-Item Parkinson's Disease Questionnaire, Freezing of Gait Questionnaire, System Usability Scale, Berg Balance Scale, Clinical Global Impression of severity/change, Participants Global Impression of severity/change) and clinical rating scales (MDS-UPDRS, UMSARS, PSP-RS, Hoehn & Yahr).



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608604


Contacts
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Contact: Gregor Wenning, MD +4351250481811 gregor.wenning@i-med.ac.at

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Gregor Wenning, Prof    +43 50 504 81811    gregor.wenning@tirol-kliniken.at   
Contact: Cecilia Raccagni, MD       cecilia.raccagni@tirol-kliniken.at   
Sponsors and Collaborators
Universitätsklinik für Neurologie, Innsbruck
University of Erlangen-Nürnberg, Germany
University Hospital Erlangen, Germany
Ecole Polytechnique Fédérale de Lausanne, Switzerland
University of Lausanne Hospital, Switzerland
Medical University Innsbruck
University of Luxembourg, Luxembourg
Hospital of Bolzani, Italy
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Responsible Party: Gregor Wenning, Head of Department of Neurobiology, Medical University of Innsbruck, Principal Investigator, Clinical Professor, Universitätsklinik für Neurologie, Innsbruck
ClinicalTrials.gov Identifier: NCT04608604    
Other Study ID Numbers: 1290/2020
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases