TY - JOUR
T1 - Effects of physiotherapy and home-based training in parkinsonian syndromes
T2 - protocol for a randomised controlled trial (MobilityAPP)
AU - Raccagni, Cecilia
AU - Sidoroff, Victoria
AU - Paraschiv-Ionescu, Anisoara
AU - Roth, Nils
AU - Schönherr, Gudrun
AU - Eskofier, Björn
AU - Gassner, Heiko
AU - Kluge, Felix
AU - Teatini, Francesco
AU - Seppi, Klaus
AU - Goebel, Georg
AU - Benninger, David H.
AU - Aminian, Kamiar
AU - Klucken, Jochen
AU - Wenning, Gregor
N1 - Funding
This multicentre trial is funded as a DACH (Deutschland, Austria, Switzerland-confoederatio Helvetica (CH)) joint project by the FWF I 4795-B (Austrian Science Fund), the Deutsche Forschungsgemeinschaft (DFG)— Projektnummer 438496663, funding number ES 434/12-1 and KL 1395/10-1, respectively, and the Swiss National Science Foundation (SNSF), funding number FNS 320030E_192211. The study site Luxembourg is funded by additional grants (FNR PEARL dHealthPD, Luxembourg). Study personal, sensors and other material will be financed from this grant. Same applies for the patient’s travel costs to the study visits, and accommodation if necessary. Shipment of the sensors and possible overall costs will be payed by study site as well. This funding sources had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.
Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/5/1
Y1 - 2024/5/1
N2 - INTRODUCTION: Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT). METHODS AND ANALYSIS: This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson's disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention. ETHICS AND DISSEMINATION: This study, registered as 'Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)' at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient's recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial. TRIAL REGISTRATION NUMBER: NCT04608604.
AB - INTRODUCTION: Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT). METHODS AND ANALYSIS: This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson's disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention. ETHICS AND DISSEMINATION: This study, registered as 'Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)' at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient's recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial. TRIAL REGISTRATION NUMBER: NCT04608604.
KW - Gait Analysis
KW - Multiple System Atrophy
KW - Parkinson-s disease
KW - Rehabilitation medicine
UR - http://www.scopus.com/inward/record.url?scp=85192044783&partnerID=8YFLogxK
UR - https://pubmed.ncbi.nlm.nih.gov/38692728
U2 - 10.1136/bmjopen-2023-081317
DO - 10.1136/bmjopen-2023-081317
M3 - Article
C2 - 38692728
AN - SCOPUS:85192044783
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e081317
ER -