Telerehabilitation in People With Parkinson's Disease

NCT05773885 | Recruiting DMC

• 1 other identifier: RP 21/30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Disease

Keywords

Parkinson; Telerehabilitation; Activities of daily living; Quality of life; Belance; Compliance

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (10)

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

  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)

  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)

  Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

• Change in the Lee Silverman Voice Treatment LOUD assessment (LSVT/LOUD)

  Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

• Change in the Timed Up and Go test (TUG)

  Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

Other Outcomes (2)

• Gait analysis (GAIT)

  Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

• Posturograghy (POSTURE)

  Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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).

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

Control Group (CG)

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation

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.

Experimental Group (EG)

Conventional rehabilitation 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.

Control Group (CG)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ministry of Health, Italy: collaborator

Study Sites (2)

San Raffaele Cassino

Cassino, Frosinone, 03043, Italy

NOT YET RECRUITING

IRCCS San Raffaele Roma

Rome, Italy, 00163, Italy

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Patient Compliance

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dr. Sanaz Pournajaf, DPT

  IRCCS San Raffaele Roma

  PRINCIPAL INVESTIGATOR

• Prof. Marco Franceschini, MD

  IRCCS San Raffaele Roma

  STUDY CHAIR

Central Study Contacts

Dr. Sanaz Pournajaf, DPT

CONTACT

+39 0652252405; sanaz.pournajaf@sanraffaele.it

Dr. Raimondo Torcisi, PT

CONTACT

raimondo.torcisi@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blind to the study protocol
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a multicentre, single-blind (evaluator), Randomized Controlled Trial (RCT)

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: March 17, 2023
• Study Start: September 1, 2022
• Primary Completion: March 30, 2025
• Study Completion: March 31, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after official publication and upon request.
• Access Criteria: Access will be granted upon specific request to the Study Chair, Principal Investigator, Sub-Investigator, or Central Study Contact Person. Researchers must submit a formal proposal outlining the intended use of the data, which will be reviewed for scientific merit and ethical compliance. Approved requests will receive access through a secure data-sharing platform.

Locations

IT (2)