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

Mobility in Atypical Parkinsonism: a Randomized Trial of Physiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Progressive Supranuclear Palsy; Multiple System Atrophy, Parkinson Variant (Disorder)
• Intervention / Treatment: Other: Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregor Wenning, MD; Phone Number: +4351250481811; Email: gregor.wenning@i-med.ac.at

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
      • Contact: Gregor Wenning, Prof; Phone Number: +43 50 504 81811; Email: gregor.wenning@tirol-kliniken.at
      • Contact: Cecilia Raccagni, MD; Email: cecilia.raccagni@tirol-kliniken.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor-based analysis	Gait speed	Baseline to week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Rating scale	MDS-UPDRS	Baseline to week 7
Sensor-based analysis	Stride length	Baseline to week 7
PAM Secondary outcome	Number of steps per day	Baseline to week 7

Collaborators and Investigators

• Sponsor: Universitätsklinik für Neurologie, Innsbruck
• Collaborators: Medical University Innsbruck; University of Erlangen-Nürnberg, Germany; University Hospital Erlangen, Germany; Ecole Polytechnique Fédérale de Lausanne, Switzerland; University of Lausanne Hospital, Switzerland; University of Luxembourg, Luxembourg; Hospital of Bolzani, Italy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Autonomic Nervous System Diseases; Ocular Motility Disorders; Paralysis; Primary Dysautonomias; Hypotension; Ophthalmoplegia; Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Parkinsonian Disorders; Supranuclear Palsy, Progressive
• Other Study ID Numbers: 1290/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No