NCT05773885 Telerehabilitation in People With Parkinson's Disease
| NCT ID | NCT05773885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-03-30 |
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 2022-09-01 with a primary completion date of 2025-03-30.
⚠ 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
Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed. The study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.
Eligibility Criteria
Inclusion Criteria: * age between 30 and 80 years; * diagnosis of Parkinson's Disease according to the "Movement Disorders Society's diagnostic criteria"; * Hoehn \& Yahr (H\&Y) score between 2 and 3 (ON-state); * absence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 ≤ 2; * absence of cognitive impairment measured by the MoCA total score ≥ 18; * stabilized drug treatment; * have access to the Internet for TR; * have a caregiver available during rehabilitation sessions in TR; * have sufficient cognitive and linguistic level to understand and comply with study procedures; * sign informed consent. Exclusion Criteria: * having any cognitive problems or low compliance that prevent using the TR system; * other neurological pathologies, psychiatric complications or personality disorders; * musculoskeletal diseases that impair movement; * presence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 \> 2; * presence of cognitive impairment measured by the MoCA total score \< 18; * severe cognitive or linguistic deficits (inability to understand and comply with study procedures); * presence of blurred or low vision problems; * hearing and speech impairment affecting participation in the system; * absence of signature of the informed consent.
Contact & Investigator
Dr. Sanaz Pournajaf, DPT
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele Roma
Frequently Asked Questions
Who can join the NCT05773885 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05773885 currently recruiting?
Yes, NCT05773885 is actively recruiting participants. Contact the research team at sanaz.pournajaf@sanraffaele.it for enrollment information.
Where is the NCT05773885 trial being conducted?
This trial is being conducted at Cassino, Italy, Rome, Italy.
Who is sponsoring the NCT05773885 clinical trial?
NCT05773885 is sponsored by IRCCS San Raffaele Roma. The principal investigator is Dr. Sanaz Pournajaf, DPT at IRCCS San Raffaele Roma. 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.