Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

Stroke Clinical Trial

— BALANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874051
• Other study ID #: 1099/IRCCS San Camillo
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Andrea Turolla, PhD
• Phone: 00390412207
• Email: andrea.turolla[@]ospedalesancamillo.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Nervous System Diseases
• Parkinson Disease
• Stroke

Intervention

Device:
• Experimental Group
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.

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

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Mondino	Pavia
Italy	IRCCS ICS Maugeri Spa SB	Pavia
Italy	IRCCS Fondazione Santa Lucia	Rom
Italy	IRCCS San Raffaele Pisana	Rom
Italy	San Camillo IRCCS	Venice

Sponsors (5)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy	I.R.C.C.S. Fondazione Santa Lucia, IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS San Raffaele, Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Instrumental assessment	The OAK system will record the changes of the center of pressure during 30 seconds, with relaxed arms and eyes open.	Change from baseline BBS at the end of the therapy (three weeks thereafter)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)