Clinical Efficacy of a telerehabilItation Protocol, for the Improvement of Balance in Degenerative Neurological Diseases

NCT07502066 | Active Not Recruiting

• 1 other identifier: 2021.17
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis). The secondary objectives of the study are:

1. 1.To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes.
2. 2.To collect data on process measures: user needs (patients and caregivers), treatment adherence, usability, satisfaction, technological acceptance.

Conditions

Multiple Sclerosis; Parkinson Disease

Keywords

Telerehabilitation; Balance Treatment; remote rehabilitation; remote monitoring

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  The Berg Balance Scale (BBS) objectively assesses a patient's ability to safely maintain balance during 14 predetermined tasks. Each item is scored on a 5-point ordinal scale (0-4), with 0 indicating the lowest level of function and 4 the highest. The assessment takes approximately 20 minutes and excludes gait evaluation. Possible scores range from 0 to 56, with higher scores indicating better balance function.

  Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.

Secondary Outcomes (14)

• Mini-Balance Evaluation System Test (Mini-BESTest)

  Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.

• Functional Ambulation Classification (FAC)

  Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.

• 5X Sit-to-Stand Test (5XSST)

  Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.

• Activities specific-Balance Confidence (ABC) -Scale

  Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.

• Barthel Index (BI)

  Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.

Study Arms (4)

Telerehabilitation Group- Multiple Sclerosis (TR-MS)

EXPERIMENTAL

After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana). Every session will last 1h and will be done 5 times/week for 4 week.

Other: Telerehabilitation Treatment

Control Group- Multiple Sclerosis (CG-MS)

ACTIVE COMPARATOR

After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group.

Other: Conventional Treatment

Telerehabilitation Group- Parkinson's Disease (TR-PD)

EXPERIMENTAL

After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). Every session will last 1h and will be done 5 times/week for 4 week.The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana).

Other: Telerehabilitation Treatment

Control Group- Parkinson's Disease ( CG-PD)

ACTIVE COMPARATOR

After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3).Every session will last 1h and will be done 5 times/week for 4 week.The exercises proposed to the control group will be performed by the patient at home, in self-treatment.In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group.

Other: Conventional Treatment

Interventions

Telerehabilitation Treatment OTHER

The treatment will last 4 weeks; each session will be1 hour, to be performed five times a week. Patients in the Telerehabilitation group will perform the same balance rehabilitation protocol as the controls, through the telerehabilitation system implemented by the IRCCS, which allows them to perform rehabilitation treatments at home, monitored by a hospital physiotherapist. Both groups will carry out a clinical evaluation before and after the treatments and will be contacted again briefly two months after the end of the treatment to ascertain the maintenance of the results obtained.

Also known as: remote rehabilitation

Telerehabilitation Group- Multiple Sclerosis (TR-MS); Telerehabilitation Group- Parkinson's Disease (TR-PD)

Conventional Treatment OTHER

The conventional treatment group will perform a programme of exercises, specific for balance, contained in a booklet, in which there is a description of the activities, accompanied by explanatory pictures. On a weekly basis, a physiotherapist will contact the individuals in this group by telephone to inquire about the progress of the therapy, and provide information on how to possibly modify the mode, number of repetitions, duration and difficulty of the exercises. In addition, the patient will be provided with a diary to monitor the activities performed. The treatment will last four weeks; each session will be one hour, to be performed five times a week.

Also known as: usual care treatment

Control Group- Multiple Sclerosis (CG-MS); Control Group- Parkinson's Disease ( CG-PD)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Possession of an ADSL internet connection with a flat rate or, in the case of a pay-as-you-go tariff, with an availability of at least 20 Gigabytes/month.
• PARKINSON'S DISEASE:
• Patients with Parkinson's disease, according to the criteria of the UK Parkinson's Disease Society Brain Bank, in stabilised pharmacological treatment with L-Dopa or dopamine agonists and with a Hoehn \& Yahr scale score between 1.5 and 2.5;
• Patients presenting a score ≤ 2 in the 'freezing when walking' subitem of section II of the UPDRS;
• Patients presenting a score ≤ 2 in both duration and disability in the "dyskinesias" sub-item of section IV of the UPDRS.
• MULTIPLE SCLEROSIS
• Subjects with Multiple Sclerosis (MS) in the relapsing remitting (RRMS) or secondary progressive (SPMS) forms, according to the criteria of MC Donald 2010 \[14\], under stable drug treatment and with Expanded Disability Status Scale (EDSS) score ≤ 6.5;

You may not qualify if:

• All patients will be excluded from the study who, in association with the diagnosis of the diseases listed above, have the following comorbidities diagnosed and documented in the medical records
• Unstabilised fractures;
• Diagnosis of major depression;
• Severe deficits in visual acuity and hearing perception;
• Dementia;
• Epilepsy not controlled pharmacologically;
• Ideomotor apraxia;
• Neglect;
• Severe impairment of verbal comprehension

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo Hospital

Venice-Lido, 30126, Italy

Location

Related Publications (3)

• Chirra M, Marsili L, Wattley L, Sokol LL, Keeling E, Maule S, Sobrero G, Artusi CA, Romagnolo A, Zibetti M, Lopiano L, Espay AJ, Obeidat AZ, Merola A. Telemedicine in Neurological Disorders: Opportunities and Challenges. Telemed J E Health. 2019 Jul;25(7):541-550. doi: 10.1089/tmj.2018.0101. Epub 2018 Aug 23.

  PMID: 30136898 BACKGROUND

• Yang WC, Wang HK, Wu RM, Lo CS, Lin KH. Home-based virtual reality balance training and conventional balance training in Parkinson's disease: A randomized controlled trial. J Formos Med Assoc. 2016 Sep;115(9):734-43. doi: 10.1016/j.jfma.2015.07.012. Epub 2015 Aug 13.

  PMID: 26279172 RESULT

• Khan F, Amatya B, Kesselring J, Galea M. Telerehabilitation for persons with multiple sclerosis. Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD010508. doi: 10.1002/14651858.CD010508.pub2.

  PMID: 25854331 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Parkinson Disease

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sara Federico, PhD

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2026
• Study Start: October 14, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)