Testing Balance training against a placebo for stroke
Official title: Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
Balance training
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
KITE Research Institute, Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
Exclusion
- −Any condition other than stroke that significantly affects their postural controlControl groupThe group a new treatment is measured against.Read more → (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 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.)
- −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 siteTrial siteA hospital or clinic where a study is actually run.Read more →, pregnancy, active deep vein thrombosis)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Balance training.
Registry label: A: Balance training + transcutaneous spinal stimulation
Group B, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Balance training.
Registry label: B: Balance training + sham transcutaneous spinal stimulation
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 16 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the 12-week post-intervention follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Mini-Balance Evaluation Systems Test — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the 12-week post-intervention follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
Spinal excitability for the tibialis anterior, soleus, biceps femoris and rectus femoris — measured over From enrollment to the 12-week post-intervention follow-up.
Corticospinal excitability of the affected soleus and tibialis anterior — measured over From enrollment to the 12-week post-intervention follow-up.
Gait and standing spatiotemporal data — measured over From enrollment to the 12-week post-intervention follow-up.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06987682 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → to the 12-week post-intervention follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 16 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.