Home Rehabilitation As Continuity of Care in MS

Официальное название

"Tele-riabilitazione in Sclerosi Multipla: Continuità Terapeutica Domiciliare Dopo Trattamento Di Neuro-riabilitazione Intensiva, Studio Randomizzato Controllato Con Piattaforma Integrata Per La Riabilitazione Del Disequilibrio"

Обзор

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.

Подробное описание

Balance deficit represents one of the most frequent symptoms in patients with Multiple Sclerosis (PwMS) and one of the most disabling. Neuromotor rehabilitation is a fundamental tool for managing these symptoms: therapeutic exercise is currently the best choice for treating balance deficit. Once improvements has been achieved, this generally does not persist for a long time due to the underlying chronic-degenerative pathology: this reduction in clinical benefit, which can be graphically defined as a 'loss curve', is difficult to define due to individual differences, but it affects all MS patients. In recent years, new technologies are emerging, such as virtual reality and serious gaming, which are not presented as an alternative to intensive treatment but could find their ideal dimension in extensive treatment, allowing the patient to maintain the results achieved once the period of intensive treatment in a specialised rehabilitation facility is over. The specific objectives of this feasibility study are: to refine technical aspects of the Neuro Rehability system, to evaluate acceptability and satisfaction with its use by PwMS, to evaluate the recruitment process, adherence to the intervention, the number of drop-outs and identify potential problems, to evaluate the human resource requirements for the subsequent RCT study, to estimate the intervention effect and its variance necessary to calculate the appropriate sample size for the RCT.. Assessments will be carried out before the start (T0) and at the end (T1) of the treatment. The control group is asked to continue performing at home the normal physical activities that they may already be performing for the duration of the 12 weeks (TAU = treatment as usual). The experimental group is asked to perform the exercises of the Rehability platform, previously set up by the rehabilitation team on the basis of the training performed during the intensive rehabilitation period in the facility, at least 3 times a week and for at least 40 minutes per session. For both groups, no rehabilitation treatment will be possible except sphincter and phoniatric rehabilitation and psychological support. A descriptive statistical analysis will be used to describe the demographic and clinical characteristics of the sample. Standard data analysis techniques will be used to analyse the variables collected in both the feasibility study and the RCT. An electronic CRF will be set up to collect: clinical and demographic data on the recruited subjects; results of the tests/questionnaires.

Вмешательства

• Устройство Telerehabilitation
  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.

Первичные конечные точки

• Feasibility [Срок оценки: Home rehabilitation, from the end of the intensive treatment to the follow up evaluation (12 weeks)]

Вторичные конечные точки (9)

• Telehealthcare Satisfaction Questionnaire (TSQ) [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Telehealthcare Usability Questionnaire (TUQ) [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Timed Up and Go test (TUG) [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Timed 10-Meter Walk Test [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Equiscale test [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• 12-Item Multiple Sclerosis Walking Scale [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Modified Fatigue Impact Scale (M-FIS) [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]
• Patient Health Engagement scale (PHE scale) [Срок оценки: From the end of the intensive treatment to the follow up evaluation (12 weeks)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Италия · 3 центра

• IRCCS Istituto Auxologico Italiano — Milan
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
• IRCCS Santa Maria nascente - Fondazione Don Gnocchi — Milan

Публикации

• Benzel E. Empowerment. World Neurosurg. 2022 Jan;157:xv. doi: 10.1016/j.wneu.2021.10.132. No abstract available. PMID 34929787
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06699095 · HoReConCareMS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗