Sensor-based Balance Training With Exergaming Biofeedback

Sensor-based Balance Training With Exergaming Feedback in Patients With Chronic Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Sensor-based Balance Training; Other: Usual Balance Trainging

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00179
    • Santa Lucia foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: SBT
Active Comparator: 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.	Other: 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.; Other Names: UBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Berg Balance Scale (BBS)	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.	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
The Canadian Neurological Scale (CNS)	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.	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
The National Institutes of Health Stroke Scale (NIHSS)	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.	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
The Barthel Index (BI)	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.	baseline (t0); 4weeks (t1 - end of treatment); 8weeks (t2 - 1 month follow-up)
The Rivermead Mobility Index (RMI)	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.	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
Postural stability	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.	Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Pittsburgh Rehabilitation Participation Scale (PRPS)	The PRPS is a clinician-rated instrument to assess participation of patients during therapies. Range score 1 to 6, a higher score represents higher motivation.	Recorded at the end of each session (10 sessions administered in 4 weeks)

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): July 27, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Ischemic Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: CE/PROG.60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated may be available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No