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

Azienda Sanitaria Locale CN1 Cuneo

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Telerehabilitation exercise program; Other: Home self-exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT06052280

Resolution 982 of May 16, 2023

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Telerehabilitation Exercise group (TrE arm)

Experimental group

Treatment:

Other: Telerehabilitation exercise program

Home Self-Exercise group (HSE arm)

Active Comparator group

Treatment:

Other: Home self-exercise program