Clinical trial NCT04874051: Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases
Official title: Sensor-Based Analysis And rehabiLitation of bAlance in Neurological Diseases: a multiCentric randomizEd Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Parkinson Disease
Keywords: Balance
Sensor-based rehabilitation
Virtual Reality
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: Istituti Clinici Scientifici Maugeri SpA
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: I.R.C.C.S. Fondazione Santa Lucia
First posted: 2021-05-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)
Secondary outcomes:
measure: Number of falls during the last year
timeFrame: Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)
measure: Functional Ambulation Classification (FAC)
timeFrame: Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)
measure: Activities specific-Balance Confidence scale (ABC)
timeFrame: Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)
measure: Functional Independence Measure (FIM)
timeFrame: Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)
measure: Barthel Index (BI)
timeFrame: Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)
measure: National Institution of Health Stroke Scale (NIHSS)
timeFrame: Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)
measure: Hoehn & Yahr Scale (H&Y)
timeFrame: Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)
measure: Kurtzke Extended Disability Status Scale (EDSS)
timeFrame: Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)
Other outcomes:
measure: Instrumental assessment
timeFrame: Change from baseline BBS at the end of the therapy (three weeks thereafter)
Locations:
city: Pavia
country: Italy
facility: IRCCS Fondazione Mondino
city: Pavia
country: Italy
facility: IRCCS ICS Maugeri Spa SB
city: Rom
country: Italy
facility: IRCCS San Raffaele Pisana
city: Rom
country: Italy
facility: IRCCS Fondazione Santa Lucia
city: Venice
country: Italy
facility: San Camillo IRCCS
Study officials:
affiliation: San Camillo IRCCS
name: Andrea Turolla, PhD
role: PRINCIPAL_INVESTIGATOR
References: