NCT06052280 Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation
| NCT ID | NCT06052280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria Locale CN1 Cuneo |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-10-09 |
| Primary Completion | 2024-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-10-09 with a primary completion date of 2024-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Elona Brahimi, MD
PRINCIPAL INVESTIGATOR
Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy
Frequently Asked Questions
Who can join the NCT06052280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06052280 currently recruiting?
Yes, NCT06052280 is actively recruiting participants. Contact the research team at federica.gallo@aslcn1.it for enrollment information.
Where is the NCT06052280 trial being conducted?
This trial is being conducted at Cuneo, Italy.
Who is sponsoring the NCT06052280 clinical trial?
NCT06052280 is sponsored by Azienda Sanitaria Locale CN1 Cuneo. The principal investigator is Elona Brahimi, MD at Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.