Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

NCT04874051 | Unknown DMC

• 1 other identifier: 1099/IRCCS San Camillo
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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. 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.

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease

Keywords

Balance; Sensor-based rehabilitation; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  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 Outcomes (9)

• Number of falls during the last year

  Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)

• Functional Ambulation Classification (FAC)

  Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)

• Activities specific-Balance Confidence scale (ABC)

  Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)

• Functional Independence Measure (FIM)

  Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)

• Barthel Index (BI)

  Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)

Other Outcomes (1)

• Instrumental assessment

  Change from baseline BBS at the end of the therapy (three weeks thereafter)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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

Control Group (CG)

ACTIVE COMPARATOR

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

Interventions

Experimental Group DEVICE

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.

Experimental Group (EG)

Control Group OTHER

The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \< 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• IRCCS San Raffaele: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• I.R.C.C.S. Fondazione Santa Lucia: collaborator

Study Sites (5)

IRCCS Fondazione Mondino

Pavia, 27100, Italy

RECRUITING

IRCCS ICS Maugeri Spa SB

Pavia, 27100, Italy

RECRUITING

IRCCS San Raffaele Pisana

Rome, 00163, Italy

RECRUITING

IRCCS Fondazione Santa Lucia

Rome, 00179, Italy

RECRUITING

San Camillo IRCCS

Venice, 30126, Italy

RECRUITING

MeSH Terms

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Andrea Turolla, PhD

  San Camillo IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Turolla, PhD

CONTACT

00390412207; andrea.turolla@ospedalesancamillo.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The experimental group is treated through a sensor-based devices in a virtual environment, while the control group is treated through conventional physiotherapy for balance rehabilitation

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: September 2, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 22, 2023

Record last verified: 2022-06

Locations

IT (5)