Telerehabilitation in People With Parkinson's Disease (TEMPO)

IRCCS San Raffaele Roma

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy); Other: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05773885

RP 21/30

Details and patient eligibility

About

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.

Full description

The scientific literature has shown that appropriate exercise can decrease some non-motor symptoms of PD such as fatigue, depression, apathy, and cognitive impairment, and it can positively affect motor performance. However, access to rehabilitation centers is often difficult, with logistic and economic barriers for those not living near a specialized hospital. In recent years, the use of technologies has considerably progressed, and, with the development of telemedicine systems, remote treatments have become a viable option for the management of patients with PD.

The TR has the potential to optimize the timing, intensity, and personalization of rehabilitation intervention and offers the opportunity for a flexible implementation of treatment protocols and the ability to monitor patient progress in real-time. In particular, for patients with neurological degenerative pathologies, who need periodical and tailored rehabilitation for the whole life, the TR has proved feasible and effective. The recent systematic review by Vellata found that the literature on TR in people with PD is limited. The published studies on TR for PD showed that it is feasible and effective in maintaining and/or improving some clinical and non-clinical aspects of PD such as: balance and walking, speech and voice, quality of life, patient satisfaction. However, although 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.

In this context, the efficacy of TR in the management of motor and non-motor symptoms of PD has to be further investigated.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

The Experimental Group (EG) will carry out 30 sessions (3-5 days/week, for 6-10 weeks) of motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet home TR system (Khymeia srl, Noventa Padovana, Italy).

Treatment:

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

Control Group (CG)

Active Comparator group

Description:

The Control Group (CG) will carry out 30 sessions (3-5 days/week, for 6-10 weeks) of conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices.

Treatment:

Other: Conventional rehabilitation