Sensor-based Balance Training With Exergaming Biofeedback

I.R.C.C.S. Fondazione Santa Lucia

Status: Completed

Conditions: Stroke, Ischemic

Treatments: Device: Sensor-based Balance Training; Other: Usual Balance Trainging

Study type: Interventional

Funder types: Other

Identifiers

NCT06576999

CE/PROG.60

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of a sensor-based balance training with exergaming feedback on balance skills in chronic stroke patients.

Full description

Stroke is a leading cause of disability globally, with many survivors experiencing persistent balance impairments that affect the quality of their life. In this context, the use of balance-focused rehabilitation might represent a promising strategy over traditional methods. The integration of biofeedback and advanced technology in rehabilitation, such as audiovisual feedback, can enhance cortical activation, sensory integration, and patient engagement. Exergaming, a specific form of biofeedback, exhibits potential in improving functional recovery and motivation in stroke rehabilitation. In fact, visual feedback has shown effectiveness in chronic stroke patients. Given the rising incidence of stroke and the associated challenges, it is crucial to explore new intervention strategies that leverage technological advancements for better balance recovery. Previous studies have shown promising results in subacute stroke patients using an integrated biofeedback system that combine inertial measurement units (IMUs) and a sensorized force platform. The current study aims to evaluate the effects of sensor-based training with exergaming feedback on balance functions in individuals with chronic stroke.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Single event of cortical/subcortical ischemic stroke.
2. Onset > 180 days.
3. Lesion confirmed thought magnetic resonance (MR) or computer tomography (CT).
4. Able to stand upright with supervision or minimal assistance.

Exclusion criteria

1. Severe general impairment or concomitant diseases (i.e., Parkinson disease).
2. Orthopaedic contraindications.
3. Cognitive impairment (MINI MENTAL STATE EXAMINATION < 23).
4. Diagnosis of unilateral spatial neglect.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Sensor-based balance training

Experimental group

Description:

The sensor-based balance training is performed using an integrated system composed of five inertial measurement units (IMUs) and a force platform. The system analyze the data via a notebook and provide a real-time feedback for the patient in a 32 inch screen in form of exergaming.

Treatment:

Device: Sensor-based Balance Training

Usual balance training

Active Comparator group

Description:

The usual balance training is performed using a series of conventional balance exercises administered by a formed physiotherapist that provided a verbal feedback about the quality of execution.

Treatment:

Other: Usual Balance Trainging