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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
San Raffaele Cassino
NOT_YET_RECRUITING
Cassino
IRCCS San Raffaele Roma
RECRUITING
Rome
Contact Information
Primary
Dr. Sanaz Pournajaf, DPT
sanaz.pournajaf@sanraffaele.it
+39 0652252405
Backup
Dr. Raimondo Torcisi, PT
raimondo.torcisi@sanraffaele.it
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
Experimental: Experimental Group (EG)
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).
Active_comparator: Control Group (CG)
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.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele Roma
Collaborators: Ministry of Health, Italy

This content was sourced from clinicaltrials.gov