Stroke, IschemicNCT06576999
Sensor-based Balance Training With Exergaming Biofeedback
A study testing Sensor-based Balance Training and Usual Balance Trainging in people with Stroke, Ischemic, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Sensor-based Balance Training and Usual Balance Trainging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2017to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe general impairment or concomitant diseases (i.e., Parkinson disease).
- Orthopaedic contraindications.
- Cognitive impairment (MINI MENTAL STATE EXAMINATION < 23).
- Diagnosis of unilateral spatial neglect.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- Sensor-based Balance Training, Usual Balance Trainging
- Keywords
- Chronic Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor-based Balance TrainingDevice
Also called SBT
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.
Usual Balance TraingingOther
Also called UBT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Balance Trainging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 May 2017
- Primary completion27 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576999
- Sponsor's protocol ID
- CE/PROG.60
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated may be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-based Balance Training With Exergaming Feedback in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06576999
- Acronym / sponsor ID
- CE/PROG.60
- Conditions
- Stroke, Ischemic
- Keywords
- Chronic Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 27 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sensor-based balance training | Experimental | Device: Sensor-based Balance TrainingThe 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. |
| Usual balance training | Active comparator | Other: Usual Balance TraingingThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Severe general impairment or concomitant diseases (i.e., Parkinson disease).
- Orthopaedic contraindications.
- Cognitive impairment (MINI MENTAL STATE EXAMINATION < 23).
- Diagnosis of unilateral spatial neglect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor-based Balance TrainingAlso: SBT10 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. | Device | Sensor-based balance training |
| Usual Balance TraingingAlso: UBT10 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 | Usual balance training |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No. The datasets generated may be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-based Balance Training and Usual Balance Trainging in people with Stroke, Ischemic, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Berg Balance Scale (BBS) (time frame: Before training (t0); after 4 weeks of treatment (t1); after 8 weeks from the baseline (t2)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.