Mobility in Atypical Parkinsonism: a Trial of Physiotherapy

NCT04608604 | Completed

• 1 other identifier: 1290/2020
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple System Atrophy, Parkinson Variant (Disorder); Parkinson Disease; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• Sensor-based analysis

  Gait speed

  Baseline to week 7

Secondary Outcomes (3)

• Clinical Rating scale

  Baseline to week 7

• Sensor-based analysis

  Baseline to week 7

• PAM Secondary outcome

  Baseline to week 7

Study Arms (2)

Physiotherapy 1

ACTIVE COMPARATOR

Other: Physiotherapy

Physiotherapy 2

ACTIVE COMPARATOR

Other: Physiotherapy

Interventions

Physiotherapy OTHER

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.

Physiotherapy 1; Physiotherapy 2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Victoria Sidoroff: lead
• University of Lausanne Hospitals: collaborator
• Medical University Innsbruck: collaborator
• University of Luxembourg: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• Regional Hospital of Bolzano: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• University Hospital Erlangen: collaborator
• Reha Rheinfelden: collaborator
• Klinik Lengg, Zurich: collaborator

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (2)

• Sidoroff V, Moradi H, Prigent G, Jagusch F, Teckenburg I, Asalian M, Hergenroeder-Lenzner N, Giraitis M, Schoenfeldt-Reichmann ET, Ndayisaba JP, Goebel G, Seppi K, Ionescu A, Krismer F, Benninger D, Winkler J, Eskofier BM, Klucken J, Aminian K, Wenning G, Sapienza S, Gassner H, Raccagni C; MobilityAPP Study Group. Moving beyond the hospital: in-depth characterization of daily-life mobility in patients with atypical Parkinsonian disorders. NPJ Parkinsons Dis. 2026 Jan 12. doi: 10.1038/s41531-025-01242-2. Online ahead of print.

  PMID: 41526364 DERIVED

• Raccagni C, Sidoroff V, Paraschiv-Ionescu A, Roth N, Schonherr G, Eskofier B, Gassner H, Kluge F, Teatini F, Seppi K, Goebel G, Benninger DH, Aminian K, Klucken J, Wenning G. Effects of physiotherapy and home-based training in parkinsonian syndromes: protocol for a randomised controlled trial (MobilityAPP). BMJ Open. 2024 May 1;14(5):e081317. doi: 10.1136/bmjopen-2023-081317.

  PMID: 38692728 DERIVED

MeSH Terms

Conditions

Multiple System Atrophy; Parkinson Disease; Supranuclear Palsy, Progressive

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Investigator, Department of Neurology, Medical University of Innsbruck

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 29, 2020
• Study Start: February 1, 2021
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)