Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases (BALANCE)

March 20, 2023 updated by: IRCCS San Camillo, Venezia, Italy

Sensor-Based Analysis And rehabiLitation of bAlance in Neurological Diseases: a multiCentric randomizEd Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • IRCCS Fondazione Mondino
        • Contact:
        • Sub-Investigator:
          • Roberto De Icco
      • Pavia, Italy, 27100
      • Rom, Italy, 00163
        • Recruiting
        • IRCCS San Raffaele Pisana
        • Contact:
        • Contact:
          • Phone Number: 06660581
        • Sub-Investigator:
          • Michela Goffredo
      • Rom, Italy, 00179
      • Venice, Italy, 30126
        • Recruiting
        • San Camillo IRCCS
        • Sub-Investigator:
          • Francesca Baldan
        • Sub-Investigator:
          • Sara Federico
        • Sub-Investigator:
          • Martina Pavanetto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (EG)
In the EG the subjects will perform balance exercises using the OAK system under the supervision of a trained physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.
Device: Experimental Group
The experimental treatment will be provided by means of the OAK system. This device consists of 1 cabinet with 2 independent balance boards, 2 monitors (one for the physiotherapist and one for the patient) and 3 wireless IMUs (one for the left lower limb, one for the right lower limb and one for the trunk). The 2 balance boards provide body weight transfer exercises, while the wireless motion sensors provide one leg stance exercises or trunk exercises in a virtual environment.
Active Comparator: Control Group (CG)
In the CG the subjects will be asked to perform conventional balance exercises under the supervision of a physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.
Other: Control Group
The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 56).
Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of falls during the last year
Time Frame: Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions).
Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)
Functional Ambulation Classification (FAC)
Time Frame: Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 5).
Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)
Activities specific-Balance Confidence scale (ABC)
Time Frame: Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 100).
Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)
Functional Independence Measure (FIM)
Time Frame: Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 126).
Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)
Barthel Index (BI)
Time Frame: Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 100).
Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)
National Institution of Health Stroke Scale (NIHSS)
Time Frame: Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 42).
Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 147).
Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)
Hoehn & Yahr Scale (H&Y)
Time Frame: Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 5).
Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)
Kurtzke Extended Disability Status Scale (EDSS)
Time Frame: Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 10).
Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental assessment
Time Frame: Change from baseline BBS at the end of the therapy (three weeks thereafter)
The OAK system will record the changes of the center of pressure during 30 seconds, with relaxed arms and eyes open.
Change from baseline BBS at the end of the therapy (three weeks thereafter)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Camillo, Venezia, Italy

Collaborators

IRCCS San Raffaele
I.R.C.C.S. Fondazione Santa Lucia
Istituti Clinici Scientifici Maugeri SpA
IRCCS National Neurological Institute "C. Mondino" Foundation

Investigators

  • Principal Investigator: Andrea Turolla, PhD, San Camillo IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1099/IRCCS San Camillo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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