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RECRUITINGINTERVENTIONAL

Telerehabilitation in People With Parkinson's Disease

Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)

The patients will carry out motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy). The motor exercises will be performed using inertial sensors for the acquisition and processing of the movement performed by the patient. This data is shown to the patient with visual and auditory feedback in a serious games environment. The exercises will cover the rehabilitation of balance and lower limbs, for example Balance on one leg, March in place, Stand on tiptoe, Squat, etc. The physiotherapists involved in the study will define a protocol of exercises in TR mode customized according to the characteristics and needs of the patient. The exercises in the speech therapy and cognitive domains will be defined by the specialized staff based on the characteristics of the patient. The duration of the rehabilitation treatments is 9 hours per week.

OTHER

Conventional rehabilitation

The patients will carry out conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices. The motor exercises will concern the rehabilitation of balance, trunk, and lower limbs and will be performed with a physiotherapist who will customize the treatment based on the characteristics and needs of the patient. The occupational therapy, speech therapy, psychotherapy treatments will be defined by the specialized staff based on the characteristics of the patient. The duration of the rehabilitation treatments is 9 hours per week.

Locations (2)

San Raffaele Cassino
Cassino, Frosinone, Italy
IRCCS San Raffaele Roma
Rome, Italy, Italy