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Completed

NCT Number: NCT06576999

Sensor-based Balance Training With Exergaming Biofeedback

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Lucia Foundation

Rome, 00179, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sensor-based Balance Training

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.

Other names: SBT

Usual Balance Trainging

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.

Other names: UBT

Primary outcomes

  1. The Berg Balance Scale (BBS)

    Time frame: 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.

  2. The Canadian Neurological Scale (CNS)

    Time frame: 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.

  3. The National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 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.

  4. The Barthel Index (BI)

    Time frame: 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.

  5. The Rivermead Mobility Index (RMI)

    Time frame: 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.

  6. Postural stability

    Time frame: 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.

Other outcomes

  1. The Pittsburgh Rehabilitation Participation Scale (PRPS)

    Time frame: Recorded at the end of each session (10 sessions administered in 4 weeks)

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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