Actively Recruiting
Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation
Led by Azienda Sanitaria Locale CN1 Cuneo · Updated on 2024-08-06
40
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 or older
- Medical diagnosis of idiopathic Parkinson Disease according to the most recent Movement Disorder Society diagnostic criteria
- Parkinson Disease stage 2 or lower on the Hoehn and Yahr scale
- Montreal Cognitive Assessment score greater than 25
- Ability to read, understand, and provide written informed consent
- Motivation and ability to attend planned visits and follow study procedures
- For telerehabilitation group: wireless internet access at home
- For telerehabilitation group: adequate space to place the telerehabilitation device (about 2 meters in front)
You will not qualify if you...
- Under 18 years of age
- Any atypical, iatrogenic, or secondary Parkinsonism
- Parkinson Disease stage higher than 2 on the Hoehn and Yahr scale
- Severe orthopedic, vascular, respiratory, or cardiac conditions or other medical issues limiting participation in moderate exercise or the study as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Azienda Sanitaria Locale CN1
Cuneo, Italy, 12030
Actively Recruiting
Research Team
F
Federica Gallo, Biostatistic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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