Multiple System Atrophy, Parkinson Variant (Disorder)Mobility_APPNCT04608604
Mobility in Atypical Parkinsonism: a Trial of Physiotherapy
A study testing Physiotherapy in people with Multiple System Atrophy, Parkinson Variant (Disorder) and Parkinson Disease, run by Victoria Sidoroff at 1 site in Austria.
Trial 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)… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Multiple System Atrophy, Parkinson Variant (Disorder), Parkinson Disease, Progressive Supranuclear Palsy
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2021to 8 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Multiple System Atrophy, Parkinson Variant (Disorder), Parkinson Disease, Progressive Supranuclear Palsy
- Being tested
- Physiotherapy
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy 1 | Active comparator | Not described Receives: Other: Physiotherapy |
| Physiotherapy 2 | Active comparator | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor-based analysis
Gait speed
Measured: Baseline to week 7
Secondary outcomes (3)
Clinical Rating scale
Movement Disorder Society - Unified Parkinson's Disease Rating Scale - MDS-UPDRS III (0-132 points, higher scores indicate higher motor impairment)
Measured: Baseline to week 7
Sensor-based analysis
Stride length
Measured: Baseline to week 7
PAM Secondary outcome
Number of steps per day
Measured: Baseline to week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Feb 2021
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple System Atrophy, Parkinson Variant (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victoria Sidoroff
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, Medical University Innsbruck, University of Luxembourg, Friedrich-Alexander-Universität Erlangen-Nürnberg, Regional Hospital of Bolzano, Ecole Polytechnique Fédérale de Lausanne, University Hospital Erlangen, Reha Rheinfelden, Klinik Lengg, Zurich
- Responsible party
- Sponsor-investigator, Victoria Sidoroff, Universitätsklinik für Neurologie, Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608604
- Sponsor's protocol ID
- 1290/2020
- Acronym
- Mobility_APP
- Status last verified
- May 2025
- First submitted
- 19 Oct 2020
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;12(1):34. doi: 10.1038/s41531-025-01242-2.
PubMed 41526364Raccagni 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.
PubMed 38692728
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility in Atypical Parkinsonism: a Randomized Trial of Physiotherapy
- ClinicalTrials.gov ID
- NCT04608604
- Acronym / sponsor ID
- Mobility_APP / 1290/2020
- Conditions
- Multiple System Atrophy, Parkinson Variant (Disorder), Parkinson Disease, Progressive Supranuclear Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Victoria SidoroffUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, Medical University Innsbruck, University of Luxembourg, Friedrich-Alexander-Universität Erlangen-Nürnberg, Regional Hospital of Bolzano, Ecole Polytechnique Fédérale de Lausanne, University Hospital Erlangen, Reha Rheinfelden, Klinik Lengg, Zurich
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy 1 | Active comparator | Other: Physiotherapy |
| Physiotherapy 2 | Active comparator | Other: Physiotherapy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyPatients 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. | Other | Physiotherapy 1, Physiotherapy 2 |
Primary outcome
Sensor-based analysis
Time frame: Baseline to week 7
Gait speed
3 secondary outcomes
Clinical Rating scale
Time frame: Baseline to week 7
Sensor-based analysis
Time frame: Baseline to week 7
PAM Secondary outcome
Time frame: Baseline to week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41526364Sidoroff 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;12(1):34. doi: 10.1038/s41531-025-01242-2.
- Derived from this study: PubMed 38692728Raccagni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Multiple System Atrophy, Parkinson Variant (Disorder) and Parkinson Disease, run by Victoria Sidoroff at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor-based analysis (time frame: Baseline to week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.