RCT on Telerehabilitation Efficacy in Parkinson's Disease

NCT05842577 | Completed

• 1 other identifier: RP 01/18
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 6

Brief Summary

The implementation of regular prolonged, and effective rehabilitation in people with Parkinson's disease is essential for ensuring a good quality of life. However, the continuity of rehabilitation care may find barriers related to economic, geographic, and social issues. In these scenarios, telerehabilitation could be a possible solution to guarantee the continuity of care. This trial aims to investigate the efficacy of non-immersive virtual reality-based telerehabilitation on postural stability in people with Parkinson's disease, compared to at-home conventional rehabilitation.

Conditions

Parkinson Disease

Keywords

Telerehabilitation; Parkinson; Balance; Continuity of Care

Outcome Measures

Primary Outcomes (1)

• Change in the mini-Balance Evaluation Systems Test (mini-BESTest)

  The mini-BESTest is a shortened version of the Balance Evaluation Systems Test. It aims to target and identify 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits. The test was shortened based on factor analysis to include dynamic balance only and to improve clinical utilization. It is 36 items scale that evaluates Balance with total score of 28.

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

Secondary Outcomes (3)

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

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

• Change in the 6-minute WalkTest (6mWT)

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

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

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

Study Arms (2)

Telerehabilitation Group (TG)

EXPERIMENTAL

The TG consisted of 30 sessions lasting approximately 45 minutes (3-5/week for 6-10 weeks) of motor, and cognitive rehabilitation exercises in non-immersive VR-based TR modality using the VRRS Tablet system (Khymeia Srl, Noventa Padovana, Italy).

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

Control Group (CG)

ACTIVE COMPARATOR

The CG carried consisted of 30 sessions lasting approximately 45 minutes (3-5 days/week for, 6-10 weeks) of at-home conventional rehabilitation via structured self-administered exercises without the use of any technological devices.

Other: At-home conventional rehabilitation

Interventions

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

The motor exercises were performed using inertial sensors for the acquisition and processing of the movement performed by the patient. The patient was trained to perform these exercises using visual and auditory feedback in a serious game environment. The exercises were aimed at the rehabilitation of balance and at the improvement of motor performance in lower limbs (e.g., maintaining balance on one leg, marching in place, standing on tiptoe, squatting, etc.). The therapists involved in the study customized the protocol of exercises in TR mode according to the characteristics and needs of the subject.

Telerehabilitation Group (TG)

At-home conventional rehabilitation OTHER

The CG rehabilitation was an active comparator treatment and consisted of a written home-based self-administered booklet with conventional motor activities tailored for each subject. The motor activities were chosen and adapted from a specialized manual. The motor exercises were aimed at the rehabilitation of balance and at the improvement of motor performance in lower limbs (e.g., maintaining balance on one leg, marching in place, standing on tiptoe, squatting, etc).

Also known as: Structured self-administered exercises

Control Group (CG)

Eligibility Criteria

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

You may qualify if:

• Hoehn \& Yahr (H\&Y) score between ≤3 (ON-state);
• the absence of moderate and severe dyskinesias assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with a score of items 4.1 and 4.2 \< 3;
• the absence of moderate and severe freezing episodes assessed by the MDS-UPDRS with a score of items 2.13 and 3.11 \< 3;
• the ability to perform the 6 Minutes Walking Test (6MWT) between 200 m and 600 m;
• age ≤ 80 years;
• the absence of cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) total score≥17.54 ;
• stabilized drug treatment;
• sufficient cognitive and linguistic level to understand and comply with study procedures;
• sign informed consent.

You may not qualify if:

• other neurological pathologies, psychiatric complications, or personality disorders;
• blurred or low vision problems;
• hearing and speech impairment affecting participation in the study.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Fondazione Salvatore Maugeri: collaborator
• IRCCS San Camillo, Venezia, Italy: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator

Study Sites (6)

IRCCS Bonino-Pulejo

Messina, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Milan, Italy

Location

IRCCS Mondino Foundation

Pavia, Italy

Location

IRCCS San Raffaele Roma

Rome, 00166, Italy

Location

IRCCS San Camillo Hospital

Venice, Italy

Location

ICS Maugeri SB IRCCS Veruno

Veruno, Italy

Location

Related Publications (3)

• 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

• 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

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Michela Goffredo, PhD

  IRCCS San Raffaele Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• 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: April 24, 2023
• First Posted: May 6, 2023
• Study Start: July 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)