Spinal Cord InjuriesNCT05744271
Evaluation of FES+VFBT With Individuals With Lived Experience
A study testing FES+VFBT in people with Spinal Cord Injuries and Stroke, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Falls are a concern for people living with spinal cord injury (SCI) or stroke. Falls may result in injury and a fear of falling, which often cause people to restrict their mobility and daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Stroke
- What is being tested?
- FES+VFBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2023to 22 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke
- chronic stage of recovery (i.e. >1 year post-SCI/D or stroke), when natural recovery has plateaued
- ≥18 years old
- able to stand independently for 60 seconds
- moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task);
- free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss)
- able to understand spoken English
Who cannot join
- a prior lower extremity fragility fracture
- an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period
- peripheral nerve damage in the legs
- contraindications for FES (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis)31
- contraindications for TMS (i.e. history of epilepsy and/or seizures)
Trial locations and contacts
1 site in 1 country.
About this study
Falls are a concern for people living with spinal cord injury (SCI) or stroke. Falls may result in injury and a fear of falling, which often cause people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI or stroke has not been studied in detail, and as a result, there is a lack of treatments to address their high fall risk.
Functional electrical stimulation (FES) is the application of a mild electrical stimulus to a muscle that helps it move better. In this study, the MyndSearch device will be used to deliver FES. The visual feedback balance training (VFBT) is similar to playing a video game on a balance board while following visual cues on a screen.
The purpose of this study is to evaluate an intervention that combines FES and VFBT to improve balance and lead to the recovery of safe mobility in individuals living with neurological disease or injury (e.g., spinal cord injury, stroke).
Read the detailed description
Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults.
A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.
Our primary objective is to evaluate the efficacy of the FES+VFBT system in a pilot study with individuals with lived experience, namely individuals with SCI/D or individuals living with stroke.
- Conditions
- Spinal Cord Injuries, Stroke
- Being tested
- FES+VFBT
- Keywords
- Balance, Functional Electrical Stimulation
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES+VFBTDevice
Standing balance training with the FES+VFBT system will occur 3x/week for six weeks (i.e. 18 sessions). Electrodes will be placed on the participants' plantarflexors and dorsiflexors bilaterally and FES will be administered using the device, MyndSearch, during the balance training exercises. Each session will last one hour, including 5 min to identify motor thresholds and maximum tolerable stimulation levels, 2 min to don/doff the safety harness, 5 min to calibrate the FES+VFBT exercises, up to 48 min to complete the FES+VFBT exercises. Rest breaks will be taken as needed.
| Study group | Role | What they receive |
|---|---|---|
| FES+VFBT | Experimental | Functional electrical stimulation combined with visual feedback balance training Receives: Device: FES+VFBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berg Balance Scale score
Scores range from 0-56, higher score equals greater balance
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change in Activities-specific Balance Confidence Scale score
Scores range from 0-100%, higher score equals greater confidence in balance
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change in strength of the trunk and lower extremity
The force, measured in lbs or kg, of eight lower extremity muscle groups (i.e. hip extensors, hip flexors, hip abductors, hip adductors, knee extensors, knee flexors, ankle plantarflexors and ankle dorsiflexors) will be measured using a hand-held dynamometer. Scores range from 0-40, higher score equals greater strength.
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change in static standing balance
Will be assessed by measuring postural sway during quiet standing on the force sensing mat for 60 seconds under two conditions presented in a random order: eyes open and eyes closed. The amount of body sway, such as COP amplitude and speed, will be quantified to examine the change of static balance as well as reliance on the visual information.
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change in dynamic standing balance
Will be assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on the force sensing mat (i.e. limits of stability test). The maximum centre of pressure (COP) amplitude in the anterior, posterior and mediolateral directions will be recorded. The change of COP amplitude will be assessed. Electromyography will be recorded in the major leg muscles. The change in co-contraction and muscle synergy will be investigated to quantify the change in muscle activation pattern by the intervention.
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Questionnaire on the participants' perspectives of the FES+VFBT intervention
Measured: Immediately after the intervention
Semi-structured interview on the participants' perspectives of the FES+VFBT intervention
Measured: Immediately after the intervention
Secondary outcomes (3)
Change in cutaneous pressure sensation
Monofilaments of six different thicknesses will be applied in order of descending thickness. Each monofilament will be applied six times with the participant's eyes closed. Participants will indicate when they can feel pressure being applied. Total score is the number of correct responses (maximum score of 72: 6 monofilaments x 6 applications x 2 toes).Scores range from 0-72, greater score equals greater cutaneous pressure sensation.
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints
With participants' eyes closed, the therapist will slowly move each joint through 10 degrees of range of motion in either the extension/plantarflexion or flexion/dorsiflexion directions. Participants will indicate the direction of the movement (i.e. down or up, respectively). Six movements per joint will be performed, resulting in a total possible score of 24 (6 movements x 4 joints). Scores range from 0-24, greater score equals greater proprioception.
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change of corticospinal excitability
Motor evoked potential induced by transcranial magnetic stimulation (TMS) will be measured during sitting to examine the corticospinal excitability.
Measured: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Apr 2023
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-subject design will be used, allowing each participant to be his/her own control. Repeated assessments will be taken over three periods: a baseline (i.e. no intervention), intervention, and follow-up.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin E Musselman, PhD, Principal investigator, KITE-Toronto Rehabilitation Institute, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744271
- Sponsor's protocol ID
- 22-5868
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FES+VFBT With Individuals With Lived Experience
- ClinicalTrials.gov ID
- NCT05744271
- Acronym / sponsor ID
- 22-5868
- Conditions
- Spinal Cord Injuries, Stroke
- Keywords
- Balance, Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 24 Feb 2023 (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.
Falls are a concern for people living with spinal cord injury (SCI) or stroke. Falls may result in injury and a fear of falling, which often cause people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI or stroke has not been studied in detail, and as a result, there is a lack of treatments to address their high fall risk.
Functional electrical stimulation (FES) is the application of a mild electrical stimulus to a muscle that helps it move better. In this study, the MyndSearch device will be used to deliver FES. The visual feedback balance training (VFBT) is similar to playing a video game on a balance board while following visual cues on a screen.
The purpose of this study is to evaluate an intervention that combines FES and VFBT to improve balance and lead to the recovery of safe mobility in individuals living with neurological disease or injury (e.g., spinal cord injury, stroke).
Detailed description
Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults.
A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.
Our primary objective is to evaluate the efficacy of the FES+VFBT system in a pilot study with individuals with lived experience, namely individuals with SCI/D or individuals living with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-subject design will be used, allowing each participant to be his/her own control. Repeated assessments will be taken over three periods: a baseline (i.e. no intervention), intervention, and follow-up.
| Arm | Type | Receives |
|---|---|---|
| FES+VFBT | Experimental | Device: FES+VFBTFunctional electrical stimulation combined with visual feedback balance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke
- chronic stage of recovery (i.e. >1 year post-SCI/D or stroke), when natural recovery has plateaued
- ≥18 years old
- able to stand independently for 60 seconds
- moderate level of trunk control as evidenced by the ability to reach forward >2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task);
Key exclusion criteria (5 listed)
- a prior lower extremity fragility fracture
- an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period
- peripheral nerve damage in the legs
- contraindications for FES (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis)31
- contraindications for TMS (i.e. history of epilepsy and/or seizures)
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 |
|---|---|---|
| FES+VFBTStanding balance training with the FES+VFBT system will occur 3x/week for six weeks (i.e. 18 sessions). Electrodes will be placed on the participants' plantarflexors and dorsiflexors bilaterally and FES will be administered using the device, MyndSearch, during the balance training exercises. Each session will last one hour, including 5 min to identify motor thresholds and maximum tolerable stimulation levels, 2 min to don/doff the safety harness, 5 min to calibrate the FES+VFBT exercises, up to 48 min to complete the FES+VFBT exercises. Rest breaks will be taken as needed. | Device | FES+VFBT |
Primary outcome
Change in Berg Balance Scale score
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Scores range from 0-56, higher score equals greater balance
Change in Activities-specific Balance Confidence Scale score
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Scores range from 0-100%, higher score equals greater confidence in balance
Change in strength of the trunk and lower extremity
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
The force, measured in lbs or kg, of eight lower extremity muscle groups (i.e. hip extensors, hip flexors, hip abductors, hip adductors, knee extensors, knee flexors, ankle plantarflexors and ankle dorsiflexors) will be measured using a hand-held dynamometer. Scores range from 0-40, higher score equals greater strength.
Change in static standing balance
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Will be assessed by measuring postural sway during quiet standing on the force sensing mat for 60 seconds under two conditions presented in a random order: eyes open and eyes closed. The amount of body sway, such as COP amplitude and speed, will be quantified to examine the change of static balance as well as reliance on the visual information.
Change in dynamic standing balance
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Will be assessed by asking participants to lean as far as possible in the forward, backward and sideways directions while standing on the force sensing mat (i.e. limits of stability test). The maximum centre of pressure (COP) amplitude in the anterior, posterior and mediolateral directions will be recorded. The change of COP amplitude will be assessed. Electromyography will be recorded in the major leg muscles. The change in co-contraction and muscle synergy will be investigated to quantify the change in muscle activation pattern by the intervention.
Questionnaire on the participants' perspectives of the FES+VFBT intervention
Time frame: Immediately after the intervention
Semi-structured interview on the participants' perspectives of the FES+VFBT intervention
Time frame: Immediately after the intervention
3 secondary outcomes
Change in cutaneous pressure sensation
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
Change of corticospinal excitability
Time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention
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 19 Mar 2026.
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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.
Kristin E Musselman, PhD principal investigator
KITE-Toronto Rehabilitation Institute, UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES+VFBT in people with Spinal Cord Injuries and Stroke, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 5 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 19 Mar 2026. 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 Canada. 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?
Change in Berg Balance Scale score (time frame: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention). The study lists 7 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 19 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.