Telerehabilitation in People With Parkinson's Disease

IRCCS San Raffaele Roma40 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

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

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.

Conventional rehabilitationOTHER

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). A higher score indicated more severe symptoms of PD.

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 Outcomes

Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD.

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)

The Parkinson's Disease Questionaire-8 is a short-form version, derived from the Parkinson's Disease Questionaire-39. It is a self-administered questionnaire, used to measure the quality of life in People with PD. It consists of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).

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)

The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points.