Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Multiple Sclerosis, Parkinson Disease

Intervention / Treatment
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* Device: Experimental Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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 walkingof 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group (EG)<br>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<br>* 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.<br>|
| Active Comparator: Control Group (CG)<br>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<br>* The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls during the last year | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Sensor-based rehabilitation, Virtual Reality