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

Overview

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.

Interventions

• 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 p
• 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 t

Primary outcome measures

• Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II [Time frame: 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 outcome measures (10)

• Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time frame: 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)]
• Change in the Parkinson's Disease Questionnaire-8 (PDQ-8) [Time frame: 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)]
• Change in the Montreal Cognitive Assessment (MoCA) [Time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)]
• Change in the Lee Silverman Voice Treatment LOUD assessment (LSVT/LOUD) [Time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)]
• Change in the Timed Up and Go test (TUG) [Time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)]
• Change in the Timed Up and Go Dual task test (TUG-D) [Time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)]
• Change in the mini-Balance Evaluation Systems Test (mini-BESTest) [Time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)]
• Change in the 10-meter WalkTest (10mWT) [Time frame: Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)]
• Change in the New Freezing of Gait Questionnaire (NFOG-Q) [Time frame: 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)]
• Change in the Activities-specific Balance Confidence scale (ABC) [Time frame: 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 2 centers

• San Raffaele Cassino — Cassino
• IRCCS San Raffaele Roma — Rome

Publications

• 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. PMID 26982525
• 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. PMID 29757774
• 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. PMID 28549757
• 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. PMID 27366343
• 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. PMID 34512495

Identifiers

NCT: NCT05773885 · RP 21/30

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗