Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases (BALANCE)

IRCCS San Camillo, Venezia, Italy

Status: Enrolling

Conditions: Stroke; Multiple Sclerosis; Parkinson Disease

Treatments: Device: Experimental Group; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04874051

1099/IRCCS San Camillo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Experimental Group (EG)

Experimental group

Description:

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.

Treatment:

Device: Experimental Group

Control Group (CG)

Active Comparator group

Description:

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.

Treatment:

Other: Control Group