Sensor-based Balance Training With Exergaming Biofeedback

Not Applicable

Completed

• Conditions: Stroke, Ischemic
• Interventions: Other: Usual Balance Trainging; Device: Sensor-based Balance Training

• Registration Number: NCT06576999
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2024-07-27
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual balance training	Usual Balance Trainging	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.
Sensor-based balance training	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.

Primary Outcome Measures

Name	Time	Method
The Berg Balance Scale (BBS)	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)	The BBS is a clinical scale used to quantitatively assess balance ability after stroke. Range score from 0 to 56 points, a higher score represents an improvement.
The National Institutes of Health Stroke Scale (NIHSS)	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)	The NIHSS Clinical scale used to quantitatively assess neurological status of stroke patients. Range score from 0 to 42, a lower score represents an improvement.
The Rivermead Mobility Index (RMI)	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)	The RMI is a questionnaire used to quantify mobility disability after stroke. Range score from 0 to 15 points, a higher score represents an improvement.
Postural stability	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)	Postural stability has been recorded via a stabilometric platform to evaluate the oscillations of patients while standing in the upright position with open/closed eyes. The lenght of the Center of Pressure (CoP) has used to assess the change in postural stability. A reduction in the CoP represents an improvement.
The Canadian Neurological Scale (CNS)	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)	The CNS is a clinical scale used to quantitatively assess neurological status of stroke patients. Range score from 1.5 to 11.5, a higher score represents an improvement.
The Barthel Index (BI)	baseline (t0); 4weeks (t1 - end of treatment); 8weeks (t2 - 1 month follow-up)	The BI is a clinical scale used to quantitatively assess functional independence after stroke. Range score from 0 to 100 points, a higher score represents an improvement.

Trial Locations

Locations (1)

Santa Lucia Foundation; 🇮🇹 Rome, Italy