Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)
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| ClinicalTrials.gov Identifier: NCT04608604 |
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Recruitment Status :
Recruiting
First Posted : October 29, 2020
Last Update Posted : March 18, 2021
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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 |
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.
| 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 : | November 1, 2022 |
| Estimated Study Completion Date : | November 1, 2023 |
| 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. |
- 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.
- 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 |
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.
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
| Contact: Gregor Wenning, MD | +4351250481811 | gregor.wenning@i-med.ac.at |
| 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 | |
| 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: | March 18, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |