Sensor-based Balance Training With Exergaming Biofeedback

NCT06576999 | Completed

• 1 other identifier: CE/PROG.60
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Chronic Ischemic Stroke

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• The Pittsburgh Rehabilitation Participation Scale (PRPS)

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

Study Arms (2)

Sensor-based balance training

EXPERIMENTAL

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

Usual balance training

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: SBT

Sensor-based balance training

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.

Also known as: UBT

Usual balance training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Santa Lucia Foundation

Rome, 00179, Italy

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised clinical trial

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 29, 2024
• Study Start: May 1, 2017
• Primary Completion: July 27, 2024
• Study Completion: July 31, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)