Status:

UNKNOWN

Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

Lead Sponsor:

IRCCS San Camillo, Venezia, Italy

Collaborating Sponsors:

IRCCS San Raffaele

Istituti Clinici Scientifici Maugeri SpA

Conditions:

Stroke

Multiple Sclerosis

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief 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...

Detailed 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 Scle...

Eligibility Criteria

Inclusion

  • 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:
  • 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

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

Key Trial Info

Start Date :

September 2 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT04874051

Start Date

September 2 2019

End Date

December 31 2023

Last Update

March 22 2023

Active Locations (5)

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Page 1 of 2 (5 locations)

1

IRCCS Fondazione Mondino

Pavia, Italy, 27100

2

IRCCS ICS Maugeri Spa SB

Pavia, Italy, 27100

3

IRCCS San Raffaele Pisana

Rome, Italy, 00163

4

IRCCS Fondazione Santa Lucia

Rome, Italy, 00179