Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation — PD-REHAB-NET  

Parkinson Disease Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT06052280
• Study type: Interventional
• Source: Azienda Sanitaria Locale CN1 Cuneo
• Contact: Federica Gallo, Biostatistic
• Phone: +390174676121
• Email: federica.gallo@aslcn1.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Completion date: October 2025