Clinical trial NCT06576999: Sensor-based Balance Training With Exergaming Biofeedback
Official title: Sensor-based Balance Training With Exergaming Feedback in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Chronic Ischemic Stroke
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Berg Balance Scale (BBS)
timeFrame: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
measure: The Canadian Neurological Scale (CNS)
timeFrame: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
measure: The National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
measure: The Barthel Index (BI)
timeFrame: baseline (t0); 4weeks (t1 - end of treatment); 8weeks (t2 - 1 month follow-up)
measure: The Rivermead Mobility Index (RMI)
timeFrame: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
measure: Postural stability
timeFrame: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
Secondary outcomes:
Other outcomes:
measure: The Pittsburgh Rehabilitation Participation Scale (PRPS)
timeFrame: Recorded at the end of each session (10 sessions administered in 4 weeks)
Locations:
city: Rome
country: Italy
facility: Santa Lucia Foundation
Study officials:
References: