Clinical trial NCT05773885: Telerehabilitation in People With Parkinson's Disease
Official title: Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson
Telerehabilitation
Activities of daily living
Quality of life
Belance
Compliance
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2023-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a multicentre, single-blind (evaluator), Randomized Controlled Trial (RCT)
Primary purpose: TREATMENT

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.

Detailed 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.

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.

Primary outcomes:
measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
Secondary outcomes:
measure: Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
measure: Change in the Parkinson's Disease Questionnaire-8 (PDQ-8)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
measure: Change in the Montreal Cognitive Assessment (MoCA)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Change in the Lee Silverman Voice Treatment LOUD assessment (LSVT/LOUD)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Change in the Timed Up and Go test (TUG)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Change in the Timed Up and Go Dual task test (TUG-D)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Change in the mini-Balance Evaluation Systems Test (mini-BESTest)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Change in the 10-meter WalkTest (10mWT)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Change in the New Freezing of Gait Questionnaire (NFOG-Q)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
measure: Change in the Activities-specific Balance Confidence scale (ABC)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
Other outcomes:
measure: Gait analysis (GAIT)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
measure: Posturograghy (POSTURE)
timeFrame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Locations:
city: Cassino
country: Italy
facility: San Raffaele Cassino
state: Frosinone
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Dr. Sanaz Pournajaf, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Roma
name: Prof. Marco Franceschini, MD
role: STUDY_CHAIR
References:
citation: Barbour PJ, Arroyo J, High S, Fichera LB, Staska-Pier MM, McMahon MK. Telehealth for patients with Parkinson's disease: delivering efficient and sustainable long-term care. Hosp Pract (1995). 2016;44(2):92-7. doi: 10.1080/21548331.2016.1166922.
citation: Cikajlo I, Hukic A, Dolinsek I, Zajc D, Vesel M, Krizmanic T, Blazica B, Biasizzo A, Novak F, Peterlin Potisk K. Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? Int J Rehabil Res. 2018 Sep;41(3):230-238. doi: 10.1097/MRR.0000000000000291.
citation: Linares-Del Rey M, Vela-Desojo L, Cano-de la Cuerda R. Mobile phone applications in Parkinson's disease: A systematic review. Neurologia (Engl Ed). 2019 Jan-Feb;34(1):38-54. doi: 10.1016/j.nrl.2017.03.006. Epub 2017 May 23. English, Spanish.
citation: Magrinelli F, Picelli A, Tocco P, Federico A, Roncari L, Smania N, Zanette G, Tamburin S. Pathophysiology of Motor Dysfunction in Parkinson's Disease as the Rationale for Drug Treatment and Rehabilitation. Parkinsons Dis. 2016;2016:9832839. doi: 10.1155/2016/9832839. Epub 2016 Jun 6.
citation: Vellata C, Belli S, Balsamo F, Giordano A, Colombo R, Maggioni G. Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Front Neurol. 2021 Aug 26;12:627999. doi: 10.3389/fneur.2021.627999. eCollection 2021.