Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

Last updated: March 20, 2023
Sponsor: IRCCS San Camillo, Venezia, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT04874051
1099/IRCCS San Camillo
  • Ages 18-90
  • All Genders

Study Summary

Balance impairment is one of the most common disorders due to a neurological diseases. Sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. OAK Elderly Care System (Khymeia Group, Noventa Padovana, Italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.

Eligibility Criteria

Inclusion

Inclusion Criteria: Common criteria:

  • Berg Balance Scale < 50/56;
  • Ability to maintain the standing position with o without one support for 1 minute;
  • Functional Independence measure < 100/126;
  • Barthel Index < 80/100. Stroke:
  • Single ischemic stroke;
  • Lesion occured after 2 and within 18 months;
  • National Institute of Health Stroke Scale ≤ 14. Parkinson:
  • 1.5 < Hoehn & Yahr < 3;
  • Subitem "freezing when walking"of the UPDRS ≤ 2. Multiple Sclerosis:
  • Relapsing remitting or secondary progressive Multiple Sclerosis;
  • Expanded Disability Status Scale ≤ 6.5.

Exclusion

Exclusion Criteria:

  • Untreated epilepsy;
  • Major depressive disorder;
  • Fractures;
  • Dementia;
  • Ideomotor Apraxia;
  • Neglect;
  • Severe impairment of verbal comprehension;
  • Severe acoustic and visual disorders.

Study Design

Total Participants: 120
Study Start date:
September 02, 2019
Estimated Completion Date:
December 31, 2023

Study Description

The aim of the study is to compare the therapy provided by means of the OAK Elderly Care System with conventional physiotherapy for balance rehabilitation in patients affected by stroke, Multiple Sclerosis (MS) and Parkinson Disease (PD).

OAK Elderly Care System consists of two independent balance boards and three sensors for the kinematic tracking of the trunk and lower limbs. These components allow the assessment of the centre of pressure and the execution of exercises in a virtual environment.

120 patients (40 stroke, 40 MS, 40 PK) hospitalized at 4 different italian hospitals, were enrolled according to inclusion and exclusion criteria and randomly assigned to two groups (i.e. intervention group, control group). Intervention group received 1 daily hour of technology-based treatment, while the control group underwent 1 daily hour of physiotherapy for balance rehabilitation, in addiction to 1 hour of conventional physiotherapy. Both treatments lasted 15 sessions. Before and after treatment balance, walking, daily living autonomy and pathology-specific features were assessed.

Connect with a study center

  • IRCCS Fondazione Mondino

    Pavia, 27100
    Italy

    Active - Recruiting

  • IRCCS ICS Maugeri Spa SB

    Pavia, 27100
    Italy

    Active - Recruiting

  • IRCCS Fondazione Santa Lucia

    Rom, 00179
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Pisana

    Rom, 00163
    Italy

    Active - Recruiting

  • San Camillo IRCCS

    Venice, 30126
    Italy

    Active - Recruiting

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