Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

Not Applicable

• Conditions: Multiple Sclerosis; Parkinson Disease; Stroke
• Interventions: Device: Experimental Group; Other: Control Group

• Registration Number: NCT04874051
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Study Timeline

• Study Start: 2019-09-02
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-05
• Status Verified: 2022-06
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group (EG)	Experimental Group	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.
Control Group (CG)	Control Group	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.

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	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).

Secondary Outcome Measures

Name	Time	Method
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)	Applied at the beginning and at the end of treatment (after 15 sessions).
Activities specific-Balance Confidence scale (ABC)	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).
Barthel Index (BI)	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).
National Institution of Health Stroke Scale (NIHSS)	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).
Hoehn & Yahr Scale (H&Y)	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).
Kurtzke Extended Disability Status Scale (EDSS)	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).
Functional Independence Measure (FIM)	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).
Unified Parkinson's Disease Rating Scale (UPDRS)	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).
Functional Ambulation Classification (FAC)	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).

Trial Locations

Locations (5)

IRCCS ICS Maugeri Spa SB; 🇮🇹 Pavia, Italy

IRCCS Fondazione Mondino; 🇮🇹 Pavia, Italy

IRCCS San Raffaele Pisana; 🇮🇹 Rom, Italy

IRCCS Fondazione Santa Lucia; 🇮🇹 Rom, Italy

San Camillo IRCCS; 🇮🇹 Venice, Italy