Home Rehabilitation As Continuity of Care in MS

NCT06699095 | Recruiting

• 1 other identifier: HoReConCareMS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

RCT pilot study to evaluate adherence, satisfaction and feasibility in the use of a telemedicine station for balance rehabilitation in patients with multiple sclerosis. The platform is designed as a tool for maintenance rehabilitation in a home setting and not as an alternative to intensive treatment in hospital, and is therefore compared to maintenance treatment as usual (TAU) after intensive treatment.

Conditions

Multiple Sclerosis

Keywords

Balance rehabilitation; Telemedicine; Home rehabilitation

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Safety in the use of the telemedicine system - number of sessions played and number of adverse events/number of dropouts

  Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)

Secondary Outcomes (9)

• Telehealthcare Satisfaction Questionnaire (TSQ)

  From the end of the intensive treatment to the follow up evaluation (12 weeks)

• Telehealthcare Usability Questionnaire (TUQ)

  From the end of the intensive treatment to the follow up evaluation (12 weeks)

• Timed Up and Go test (TUG)

  From the end of the intensive treatment to the follow up evaluation (12 weeks)

• Timed 10-Meter Walk Test

  From the end of the intensive treatment to the follow up evaluation (12 weeks)

• Equiscale test

  From the end of the intensive treatment to the follow up evaluation (12 weeks)

Study Arms (2)

Interventional, telemedicine group

EXPERIMENTAL

Patients will perform a 12 weeks rehabilitation program through telemedicine at home after intensive rehabilitation in hospital

Device: Telerehabilitation

Control group

NO INTERVENTION

Patients will perform a 12 weeks maintenance rehabilitation program as usual care (TAU treatment as usual) at home after intensive rehabilitation in hospital

Interventions

Telerehabilitation DEVICE

Patients will perform a 12 weeks rehabilitation program through telemedicine at home after intensive rehabilitation in hospital. Balance rehabilitation program will be scheduled on the patients' need and ability to be performed three times a week with high levels of satisfaction and safety at home under remote control of the physical therapist.

Also known as: Telemedicine

Interventional, telemedicine group

Eligibility Criteria

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

You may qualify if:

• Expanded Disability Status Scale score between 3 and 6
• Sensory Organisation Test Equitest values indicating balance impairment

You may not qualify if:

• visual impairments
• orthopedic impairments
• inability to perform balance rehabilitation in stand up position

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• Istituto Auxologico Italiano: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (3)

IRCCS Istituto Auxologico Italiano

Milan, MI, 20122, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, MI, 20133, Italy

NOT YET RECRUITING

IRCCS Santa Maria nascente - Fondazione Don Gnocchi

Milan, MI, 20148, Italy

ACTIVE NOT RECRUITING

Related Publications (13)

• Benzel E. Empowerment. World Neurosurg. 2022 Jan;157:xv. doi: 10.1016/j.wneu.2021.10.132. No abstract available.

  PMID: 34929787 BACKGROUND

• Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.

  PMID: 21387374 BACKGROUND

• Truijen S, Abdullahi A, Bijsterbosch D, van Zoest E, Conijn M, Wang Y, Struyf N, Saeys W. Effect of home-based virtual reality training and telerehabilitation on balance in individuals with Parkinson disease, multiple sclerosis, and stroke: a systematic review and meta-analysis. Neurol Sci. 2022 May;43(5):2995-3006. doi: 10.1007/s10072-021-05855-2. Epub 2022 Feb 17.

  PMID: 35175439 BACKGROUND

• Yazgan YZ, Tarakci E, Tarakci D, Ozdincler AR, Kurtuncu M. Comparison of the effects of two different exergaming systems on balance, functionality, fatigue, and quality of life in people with multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2020 Apr;39:101902. doi: 10.1016/j.msard.2019.101902. Epub 2019 Dec 21.

  PMID: 31924591 BACKGROUND

• Cimino V, Chisari CG, Raciti G, Russo A, Veca D, Zagari F, Calabro RS, Patti F. Objective evaluation of Nintendo Wii Fit Plus balance program training on postural stability in Multiple Sclerosis patients: a pilot study. Int J Rehabil Res. 2020 Sep;43(3):199-205. doi: 10.1097/MRR.0000000000000408.

  PMID: 32371848 BACKGROUND

• Celesti A, Cimino V, Naro A, Portaro S, Fazio M, Villari M, Calabro RS. Recent Considerations on Gaming Console Based Training for Multiple Sclerosis Rehabilitation. Med Sci (Basel). 2022 Feb 11;10(1):13. doi: 10.3390/medsci10010013.

  PMID: 35225946 BACKGROUND

• Kim Y, Lai B, Mehta T, Thirumalai M, Padalabalanarayanan S, Rimmer JH, Motl RW. Exercise Training Guidelines for Multiple Sclerosis, Stroke, and Parkinson Disease: Rapid Review and Synthesis. Am J Phys Med Rehabil. 2019 Jul;98(7):613-621. doi: 10.1097/PHM.0000000000001174.

  PMID: 30844920 BACKGROUND

• Garcia-Munoz C, Cortes-Vega MD, Heredia-Rizo AM, Martin-Valero R, Garcia-Bernal MI, Casuso-Holgado MJ. Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Feb 21;9(2):590. doi: 10.3390/jcm9020590.

  PMID: 32098162 BACKGROUND

• Donze C, Massot C. Rehabilitation in multiple sclerosis in 2021. Presse Med. 2021 Jun;50(2):104066. doi: 10.1016/j.lpm.2021.104066. Epub 2021 May 11.

  PMID: 33989721 BACKGROUND

• Manjaly ZM, Harrison NA, Critchley HD, Do CT, Stefanics G, Wenderoth N, Lutterotti A, Muller A, Stephan KE. Pathophysiological and cognitive mechanisms of fatigue in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2019 Jun;90(6):642-651. doi: 10.1136/jnnp-2018-320050. Epub 2019 Jan 25.

  PMID: 30683707 BACKGROUND

• Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.

  PMID: 30482317 BACKGROUND

• Berrigan LI, Fisk JD, Patten SB, Tremlett H, Wolfson C, Warren S, Fiest KM, McKay KA, Marrie RA; CIHR Team in the Epidemiology and Impact of Comorbidity on Multiple Sclerosis (ECoMS). Health-related quality of life in multiple sclerosis: Direct and indirect effects of comorbidity. Neurology. 2016 Apr 12;86(15):1417-1424. doi: 10.1212/WNL.0000000000002564. Epub 2016 Mar 9.

  PMID: 26962068 BACKGROUND

• Herrera WG. Vestibular and other balance disorders in multiple sclerosis. Differential diagnosis of disequilibrium and topognostic localization. Neurol Clin. 1990 May;8(2):407-20.

  PMID: 2193219 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

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

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

Central Study Contacts

Paolo A Confalonieri, MD

CONTACT

+39 02 2394; paolo.confalonieri@istituto-besta.it

Simone Mercurio, PT

CONTACT

+39 02 2394; simone.mercurio@istituto-besta.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 21, 2024
• Study Start: November 6, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 15, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-10

Locations

IT (3)