Telerehabilitation in People With Parkinson's Disease

NCT ID: NCT05773885

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-03-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: OTHER

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.

Interventions

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 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.

Intervention Type: DEVICE

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 the specialized staff based on the characteristics of the patient.

The duration of the rehabilitation treatments is 9 hours per week.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Sanaz Pournajaf, DPT

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele Roma

Prof. Marco Franceschini, MD

Role: STUDY_CHAIR

IRCCS San Raffaele Roma

Locations

San Raffaele Cassino

Cassino, Frosinone, Italy

Site Status: NOT_YET_RECRUITING

IRCCS San Raffaele Roma

Rome, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Dr. Sanaz Pournajaf, DPT

Role: CONTACT

sanaz.pournajaf@sanraffaele.it

+39 0652252405 ext. 32405

Dr. Raimondo Torcisi, PT

Role: CONTACT

raimondo.torcisi@sanraffaele.it

Facility Contacts

Maria Francesca De Pandis, MD.

Role: primary

maria.depandis@sanraffaele.it

Dr. Lucia Gatta, PhD

Role: primary

lucia.gatta@sanraffaele.it

References

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.

Reference Type: BACKGROUND

PMID: 26982525 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29757774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28549757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27366343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34512495 (View on PubMed)

Other Identifiers

RP 21/30

Identifier Type: -

Identifier Source: org_study_id