StrokeNCT06987682
Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
A study testing Balance training in people with Stroke, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
People living with stroke have a high risk of falling and this risk increases as mobility improves over the first year post-stroke. Despite the high number of falls, there is a lack of interventions to prevent falls after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Balance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 21 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or greater
- Diagnosed with a middle cerebral artery stroke >1 year ago
- Community-dwelling (i.e. not living in long-term care or other inpatient setting)
- Able to stand independently for 60 seconds
- Able to understand spoken English
Who cannot join
- Any condition other than stroke that significantly affects their postural control (e.g. vestibular disorder, vision loss)
- A prior lower extremity fragility fracture
- A planned injection of botulinum toxin to the legs during the intervention period
- Peripheral nerve damage in the legs
- Contraindications for electrical stimulation (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)
- Contraindications for TMS (i.e. seizures, metal in the head)
- Previous participation in tSCS within the past 2 years (May affect blinding integrity. Likely uncommon; FES is rarely used in Canada post-stroke.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KITE Research Institute, Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M4G 3V9
Kristin E Musselman, PhD, 416-597-3422 ext. 6190, kristin.musselman@uhn.ca
About this study
People living with stroke have a high risk of falling and this risk increases as mobility improves over the first year post-stroke. Despite the high number of falls, there is a lack of interventions to prevent falls after stroke. One possible solution is to alter nerve activity through delivery of a stimulus, such as electrical stimulation. The purpose of this study is to describe and compare clinical, biomechanical and nerve-related outcomes between individuals with stroke who receive RBT with tSCS and those who receive RBT with sham tSCS.
- Conditions
- Stroke
- Being tested
- Balance training
- Keywords
- transcutaneous spinal cord stimulation, postural control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
Participants will don a safety harness that is secured to an overhead track. Each balance training session will involve 60 minutes of reactive balance training (RBT). For both intervention arms, trancutaneous spinal stimulation will be set up, including placing electrodes and setting stimulation amplitudes.
| Study group | Role | What they receive |
|---|---|---|
| Balance training + transcutaneous spinal stimulation | Experimental | Not described Receives: Other: Balance training |
| Balance training + sham transcutaneous spinal stimulation | Sham comparator | Not described Receives: Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Balance Evaluation Systems Test
Measured: From enrollment to the 12-week post-intervention follow-up
Spinal excitability for the tibialis anterior, soleus, biceps femoris and rectus femoris
To assess spinal excitability, double-pulse TSCS will be applied. Spinal motor thresholds will first be determined for each of the following muscles on the affected side: tibialis anterior (TA), soleus (SOL), biceps femoris (BF), and rectus femoris (RF).
Measured: From enrollment to the 12-week post-intervention follow-up
Corticospinal excitability of the affected soleus and tibialis anterior
TMS will be delivered using a magnetic stimulator with a double-cone coil
Measured: From enrollment to the 12-week post-intervention follow-up
Gait and standing spatiotemporal data
Collected using the Zeno Walkway Gait Analysis System
Measured: From enrollment to the 12-week post-intervention follow-up
Activities-specific Balance Confidence (ABC) Scale
Items are rated on a scale from 0-100% confidence. Sixteen items of the standard ABC are used to calculate a mean. Five personalized items (i.e. tasks of important to each individual participant) are used to calculate a separate mean. The minimum score is 0%, the maximum score is 100%; the higher the score, the greater the confidence.
Measured: From enrollment to the 12-week post-intervention follow-up
Lean-and-Release Test
A test of reactive balance in the forward direction. Observational and kinematic (i.e. force plate, marker) data are collected.
Measured: From enrollment to the 12-week post-intervention follow-up
Secondary outcomes (1)
Technology Acceptance Model Questionnaire
A questionnaire exploring participants' perceptions of transcutaneous spinal cord stimulation combined with reactive balance training. Participants are asked to rate each statement (e.g. I enjoyed using electrical stimulation combined with balance training) on a 5-point Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, Strongly Agree. A mean score and SD for each section will be calculated. A higher score represents greater perceived usefulness, ease of use and efficacy of the intervention.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start21 May 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary objective is to describe and compare clinical, biomechanical and neurophysiological outcomes between individuals with stroke who receive reactive balance training (RBT) with transcutaneous spinal cord stimulation (tSCS) and those who receive RBT with sham tSCS. The secondary objective is to determine the acceptability of a balance intervention combined with tSCS.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987682
- Sponsor's protocol ID
- 24-5792
- Status last verified
- Mar 2026
- First submitted
- 15 May 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
- ClinicalTrials.gov ID
- NCT06987682
- Acronym / sponsor ID
- 24-5792
- Conditions
- Stroke
- Keywords
- transcutaneous spinal cord stimulation, postural control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 May 2025 (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.
People living with stroke have a high risk of falling and this risk increases as mobility improves over the first year post-stroke. Despite the high number of falls, there is a lack of interventions to prevent falls after stroke. One possible solution is to alter nerve activity through delivery of a stimulus, such as electrical stimulation. The purpose of this study is to describe and compare clinical, biomechanical and nerve-related outcomes between individuals with stroke who receive RBT with tSCS and those who receive RBT with sham tSCS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The primary objective is to describe and compare clinical, biomechanical and neurophysiological outcomes between individuals with stroke who receive reactive balance training (RBT) with transcutaneous spinal cord stimulation (tSCS) and those who receive RBT with sham tSCS. The secondary objective is to determine the acceptability of a balance intervention combined with tSCS.
| Arm | Type | Receives |
|---|---|---|
| Balance training + transcutaneous spinal stimulation | Experimental | Other: Balance training |
| Balance training + sham transcutaneous spinal stimulation | Sham comparator | Other: Balance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or greater
- Diagnosed with a middle cerebral artery stroke >1 year ago
- Community-dwelling (i.e. not living in long-term care or other inpatient setting)
- Able to stand independently for 60 seconds
- Able to understand spoken English
Key exclusion criteria (7 listed)
- Any condition other than stroke that significantly affects their postural control (e.g. vestibular disorder, vision loss)
- A prior lower extremity fragility fracture
- A planned injection of botulinum toxin to the legs during the intervention period
- Peripheral nerve damage in the legs
- Contraindications for electrical stimulation (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)
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 |
|---|---|---|
| Balance trainingParticipants will don a safety harness that is secured to an overhead track. Each balance training session will involve 60 minutes of reactive balance training (RBT). For both intervention arms, trancutaneous spinal stimulation will be set up, including placing electrodes and setting stimulation amplitudes. | Other | Balance training + sham transcutaneous spinal stimulation, Balance training + transcutaneous spinal stimulation |
Primary outcome
Mini-Balance Evaluation Systems Test
Time frame: From enrollment to the 12-week post-intervention follow-up
Spinal excitability for the tibialis anterior, soleus, biceps femoris and rectus femoris
Time frame: From enrollment to the 12-week post-intervention follow-up
To assess spinal excitability, double-pulse TSCS will be applied. Spinal motor thresholds will first be determined for each of the following muscles on the affected side: tibialis anterior (TA), soleus (SOL), biceps femoris (BF), and rectus femoris (RF).
Corticospinal excitability of the affected soleus and tibialis anterior
Time frame: From enrollment to the 12-week post-intervention follow-up
TMS will be delivered using a magnetic stimulator with a double-cone coil
Gait and standing spatiotemporal data
Time frame: From enrollment to the 12-week post-intervention follow-up
Collected using the Zeno Walkway Gait Analysis System
Activities-specific Balance Confidence (ABC) Scale
Time frame: From enrollment to the 12-week post-intervention follow-up
Items are rated on a scale from 0-100% confidence. Sixteen items of the standard ABC are used to calculate a mean. Five personalized items (i.e. tasks of important to each individual participant) are used to calculate a separate mean. The minimum score is 0%, the maximum score is 100%; the higher the score, the greater the confidence.
Lean-and-Release Test
Time frame: From enrollment to the 12-week post-intervention follow-up
A test of reactive balance in the forward direction. Observational and kinematic (i.e. force plate, marker) data are collected.
1 secondary outcome
Technology Acceptance Model Questionnaire
Time frame: Immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin E Musselman, PhD (416-597-3422 ext. 6190, kristin.musselman@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Balance Evaluation Systems Test (time frame: From enrollment to the 12-week post-intervention follow-up). 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 23 Mar 2026.