NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07502066

Active Not RecruitingNA

Sponsor: IRCCS San Camillo, Venezia, Italy

Conditions: Multiple Sclerosis, Parkinson Disease

Interventions: Telerehabilitation Treatment, Conventional Treatment

Countries: Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Venice-Lido, Italy