Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation

Official title

Management of Initial Parkinson's Disease: a Prospective, Mono-centric, no Profit Pilot Clinical Trial Comparing Conventional Face-to-face Physiotherapy and Home-based Telerehabilitation

Overview

The Parkinson TELEREHABilitation-NET pilot study (Parkinson TELEREHAB-NET) is designed to observe and monitor PD patients in their initial phase (which includes the period from the onset of motor symptoms until the onset of motor fluctuations) and to assess the feasibility of an integrated multidimensional approach in treating and managing PD patients in a local clinical setting (ASL CN1). Chiefly, through this pilot study, feasibility and acceptability of the general experimental plan, as well as the potential for positive effects of physiotherapy in early PD patients will be assessed. So, this pilot study primarily aims at: 1. validating the feasibility of the study protocol, assessing participants' inclusion and exclusion criteria, testing instruments/procedures used for home rehabilitation (both for the Telerehabilitation Exercise group - TrE arm and for the Home Self-Exercise group - HSE arm), testing the suitability of the method for data collection; 2. obtaining the required preliminary data for the calculation of a sample size for the primary outcome, in both arms; 3. evaluating appropriateness of the consent form, recruitment potentials, time needed to receive written consent, and the required number of researchers/medical specialists/physiotherapists needed to cover the whole study path; 4. assessing patients' acceptability of the intervention, through the evaluation of the adherence to rehabilitation process (in both arms), the completeness of proposed measurements, and compliance at follow-up. Secondary objectives are the monitoring of patients' perceived quality of life, and of motor performance and non-motor symptoms through specific rating scales, after completing the whole rehabilitation path (described below) compared to baseline level, and maintenance of results over time.

Interventions

• Other Telerehabilitation exercise program
  After the outpatient intensive physical therapy program (common to both study arms), patients in the TrE group will continue with prescribed self-training at home through telerehabilitation, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down. The TrE arm will be supported by a telerehabilitation device which will be installed and t
• Other Home self-exercise program
  After the outpatient intensive physical therapy program (common to both study arms), patients in the HSE group will continue with prescribed self-training at home, at least 3 times a week for 4 weeks. Each physical exercise session will consist of at least 5 minutes of aerobic warming-up, 35 minutes of specific high-intensity exercises for PD, and 5 minutes of aerobic cool-down. The HSE arm will be given a booklet containing detailed explanations and pictures of the assigned exercises, in order

Primary outcome measures

• Study recruitment potentials [Time frame: baseline]
• Single arm recruitment potentials [Time frame: baseline]
• Adherence to study path [Time frame: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)]
• Compliance to interventions [Time frame: at end of outpatient intensive exercise program (4 weeks from baseline), after training at home (8 weeks from baseline), and for home-based training (follow-ups at 6 months and at 12 months from baseline)]

Secondary outcome measures (12)

• Cognitive functions [Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)]
• Freezing of gait [Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)]
• Movement disorders [Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)]
• Postural control [Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)]
• Sensory orientation [Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)]
• Quality of life perception [Time frame: from baseline to follow-ups (at 6 months and at 12 months from baseline)]
• Walking ability [Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)]
• Transition ability between sitting and standing [Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)]
• Backward walking ability [Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)]
• Turning ability [Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)]
• Manual dexterity [Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)]
• Transition ability between standing and prone position [Time frame: after active interventions (at 4 weeks and at 8 weeks from baseline) and at follow-ups (at 6 months and at 12 months from baseline)]

Eligibility criteria

Inclusion criteria

General:

• adults, aged 18 or older;
• medical diagnosis of idiopathic PD according the most recent Movement Disorder Society diagnostic criteria;
• disease stage ≤ 2 on the Hoehn\&Yahr scale;
• Montreal Cognitive Assessment score >25;
• ability to read, understand and provide a written informed consent, in accordance with good clinical practice and local regulations;
• motivation and possibility to show up for planned controls and to comply with the requested study procedures.

Specific for TrE arm:

• wireless internet access at home;
• adequate room to place telerehabilitation device (about 2 meters in front of device monitor).

Exclusion criteria

• <18 years of age;
• Any atypical, iatrogenic, or secondary Parkinsonism;
• Disease stage > 2 on the Hoehn\&Yahr scale;
• Any severe orthopaedic, vascular, respiratory, or cardiac problems or any other medical condition that, in the principal investigator's opinion, could limit participation in moderate exercise or the study protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Azienda Sanitaria Locale CN1 — Cuneo

Identifiers

NCT: NCT06052280 · Resolution 982 of May 16, 2023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗