Clinical Efficacy of a telerehabilItation Protocol, for the Improvemen
Clinical Efficacy of a teLerehabilItation Protocol, for the Improvement of Balance in Degenerative neurOlogical Diseases
What it found
No result yet.
What was tested
Treatment tested
- Telerehabilitation Treatment
Compared with
- Conventional Treatment
What it measured
Main measures
Berg Balance Scale
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Walking and mobility
Other measures (14)
Mini-Balance Evaluation System Test (Mini-BESTest)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Walking and mobilityFunctional Ambulation Classification (FAC)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Walking and mobility5X Sit-to-Stand Test (5XSST)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Walking and mobilityPhysical functionActivities specific-Balance Confidence (ABC) -Scale
Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Walking and mobilityBarthel Index (BI)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Walking and mobilitySix Minutes Walking Test (6MWT)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline
Walking and mobilityPhysical functionTen metres walking test (10MWT)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Walking and mobilityShort-Form-36 health outcome (SF-36)
Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
Quality of life (reported by participants)Falls questionnaire (last year-last 2 months)
Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Walking and mobilityEuroQol-5 Dimensions, 3 Levels (EQ-5D-3L)
Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.
Quality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 90
Show the full criteria
Inclusion criteria
* 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; * At the time of inclusion, at least 3 months have elapsed since the last relapse.
Exclusion criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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. To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes. 2. To collect data on process measures: user needs (patients and caregivers), treatment adherence, usability, satisfaction, technological acceptance. Participants will perform 20 rehabilitation session (physiotherapy) for balance improvement. Experimental group patients will be trheated through tele-rehabilitation performing exercise with an hospital physiotherapist. Researchers will compare telerehabilitation group to usual care group to see if there is a significant improvement in motor function, particularly in balance and mobility tests, as well as an improvement in quality of life.
Papers
Results
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.Results
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.Background
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.
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History
Started
Oct 2021
Main results due
Dec 2026
Finished
Dec 2026