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

Condition(s) studied

Investigational drug(s) / intervention(s)

Telerehabilitation Treatment: 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.

Conventional Treatment: 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.

Study 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. 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

Primary outcome measure(s)

• Berg Balance Scale — Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
  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.

Trial sites (1)

More IRCCS San Camillo, Venezia, Italy trials in Italy

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