Sensor-based Balance Training With Exergaming Biofeedback

NCT ID: NCT06576999

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2024-07-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sensor-based balance training

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.

Group Type: EXPERIMENTAL

Sensor-based Balance Training

Intervention Type: DEVICE

10 sessions of sensor-based balance training with exergaming feedback. For this training an adaptive integrated audio-visual feedback system composed of five IMUs and a force platform connected wirelessly to a computer has been used. The training protocol include exercises of balance control, encompassing a total of five distinct exercises: i) Latero-lateral load shifting while seated; ii) Load shifting while standing: latero-lateral and antero-posterior, to simulate the balance control performed during the day; iii) Load control during sit-to-stand; iv) Gait swing and loading phase response: to stimulate a correct load shifting during the swing and stance phase; v) Latero-lateral load shifting with knee flexion.

Usual balance training

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.

Group Type: ACTIVE_COMPARATOR

Usual Balance Trainging

Intervention Type: OTHER

10 sessions of usual balance training. The training includes: gait control exercises, weight shifting, and relies on both stable surfaces (i.e., steps) and unstable surfaces (i.e., oscillating platforms and various-sized fitballs). The protocol encompassed the application of stabilization techniques and the reaching of targets with the upper limb during upright position emulating the activity of daily living.

Interventions

Sensor-based Balance Training

10 sessions of sensor-based balance training with exergaming feedback. For this training an adaptive integrated audio-visual feedback system composed of five IMUs and a force platform connected wirelessly to a computer has been used. The training protocol include exercises of balance control, encompassing a total of five distinct exercises: i) Latero-lateral load shifting while seated; ii) Load shifting while standing: latero-lateral and antero-posterior, to simulate the balance control performed during the day; iii) Load control during sit-to-stand; iv) Gait swing and loading phase response: to stimulate a correct load shifting during the swing and stance phase; v) Latero-lateral load shifting with knee flexion.

Intervention Type: DEVICE

Usual Balance Trainging

10 sessions of usual balance training. The training includes: gait control exercises, weight shifting, and relies on both stable surfaces (i.e., steps) and unstable surfaces (i.e., oscillating platforms and various-sized fitballs). The protocol encompassed the application of stabilization techniques and the reaching of targets with the upper limb during upright position emulating the activity of daily living.

Intervention Type: OTHER

Other Intervention Names

SBT; UBT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Santa Lucia Foundation

Rome, , Italy

Countries

Italy

Other Identifiers

CE/PROG.60

Identifier Type: -

Identifier Source: org_study_id