Effects of physiotherapy and home-based training in parkinsonian syndromes: protocol for a randomised controlled trial (MobilityAPP)

Abstract

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.

Keywords: Gait Analysis; Multiple System Atrophy; Parkinson-s disease; Rehabilitation medicine.

Figure 1

Study flow chart. GPT, gait-focused physiotherapy; IGA, instrumented gait analysis; PAM, physical activity monitoring; PT, physiotherapy; SPT, standard physiotherapy; V, visit; W, week.

Figure 2

The upper plot shows an example of raw IMU data of one whole day recording using the PAM system. Patients were instructed to perform a battery of standardised gait test three times per day (morning, noon and evening) at home. The middle plot shows an example of an annotated test battery, including a 20 m walking test in normal, fast and slow speeds and a 2 min walk. The bottom plot illustrates a zoomed in view on the raw medio-lateral gyroscope data and corresponding gait event like initial contact (IC), terminal contact (TC) and mid-stance (MS). IMU, inertial measurement unit; PAM, physical activity monitoring.