Comparing traditional physiotherapy to home-based telerehabilitation for Parkinson's patients
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
This study tests whether traditional physiotherapy or a home-based telerehabilitation program helps people with early-stage Parkinson's disease improve their physical activity and manage their symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Sanitaria Locale CN1 Cuneo Government |
| Locations | 1 site (Cuneo) |
| Trial ID | NCT06052280 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and acceptability of a multidimensional approach to managing early-stage Parkinson's Disease (PD) patients through two different interventions: conventional physiotherapy and a home-based telerehabilitation program. Participants will be monitored to assess the effectiveness of these interventions in improving their physical activity and overall management of PD symptoms. The study will also test the suitability of data collection methods and the inclusion/exclusion criteria for participants. The goal is to gather preliminary data that could inform larger-scale studies in the future.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a medical diagnosis of idiopathic Parkinson's Disease at stage 2 or lower on the Hoehn & Yahr scale.
Not a fit: Patients with atypical Parkinsonism or those with severe comorbid conditions that limit their ability to participate in moderate exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective home-based rehabilitation strategies for early-stage Parkinson's patients, potentially improving their quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using telerehabilitation for various conditions, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cuneo
- Azienda Sanitaria Locale CN1 — Cuneo, Italy (Recruiting)
Study contacts
- Principal investigator: Elona Brahimi, MD — Neurology Unit, Movement Disorders Clinic , Local Health Authority, ASL Cuneo 1, Italy
- Study coordinator: Federica Gallo, Biostatistic
- Email: federica.gallo@aslcn1.it
- Phone: +390174676121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.