Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06052280

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Azienda Sanitaria Locale CN1

Cuneo, Italy, 12030

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Pilot Study: Parkinson's Conventional Physiotherapy vs Home-based Telerehabilitation | DecenTrialz