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StrokeBALANCENCT04874051

Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

A study testing Experimental Group in people with Stroke and Multiple Sclerosis, run by IRCCS San Camillo, Venezia, Italy at 5 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke, Multiple Sclerosis, Parkinson Disease
What is being tested?
Experimental Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesItaly
Study dates
2 Sep 2019to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

Andrea Turolla, PhD contact

00390412207 ext. 531

andrea.turolla@ospedalesancamillo.net

5 sites in 1 country

Italy5 sites, 5 recruiting

  • IRCCS Fondazione Mondino

    Pavia, 27100

    Cristina Tassorelli, Prof., 0382380425, cristina.tassorelli@unipv.it

    Roberto De Icco

    Recruiting

  • IRCCS ICS Maugeri Spa SB

    Pavia, 27100

    Giorgio Maggioni, Dr., 0322884711, giorgio.maggioni@icsmaugeri.it

    Recruiting

  • IRCCS San Raffaele Pisana

    Rome, 00163

    Marco Franceschini, Dr., marco.franceschini@sanraffaele.it

    06660581

    Recruiting

  • IRCCS Fondazione Santa Lucia

    Rome, 00179

    Giovanni Morone, Dr., g.morone@hsantalucia.it

    Recruiting

  • San Camillo IRCCS

    Venice, 30126

    Francesca Baldan

    Sara Federico

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Experimental Group, Control Group
Keywords
Balance, Sensor-based rehabilitation, Virtual Reality
Medical subject headings
Stroke, Multiple Sclerosis, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental GroupDevice

    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.

  • Control GroupOther

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

Study groups in NCT04874051
Study groupRoleWhat they receive
Experimental Group (EG)ExperimentalIn 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.
Receives: Device: Experimental Group
Control Group (CG)Active comparatorIn 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.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)

Secondary outcomes (9)

  1. Number of falls during the last year

    Applied at the beginning and at the end of treatment (after 15 sessions).

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

  2. Functional Ambulation Classification (FAC)

    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).

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

  3. Activities specific-Balance Confidence scale (ABC)

    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).

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

  4. Functional Independence Measure (FIM)

    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).

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

  5. Barthel Index (BI)

    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).

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

  6. National Institution of Health Stroke Scale (NIHSS)

    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).

    Measured: Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)

  7. Unified Parkinson's Disease Rating Scale (UPDRS)

    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).

    Measured: Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)

  8. Hoehn & Yahr Scale (H&Y)

    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).

    Measured: Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)

  9. Kurtzke Extended Disability Status Scale (EDSS)

    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).

    Measured: Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start2 Sep 2019
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874051
Sponsor's protocol ID
1099/IRCCS San Camillo
Acronym
BALANCE
Status last verified
Jun 2022
First submitted
30 Apr 2021
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group in people with Stroke and Multiple Sclerosis, run by IRCCS San Camillo, Venezia, Italy at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Turolla, PhD (00390412207 ext. 531, andrea.turolla@ospedalesancamillo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (BBS) (time frame: Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04874051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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