Status:
RECRUITING
Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
Lead Sponsor:
University Health Network, Toronto
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 t...
Eligibility Criteria
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 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 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)
- Contraindications for TMS (i.e. seizures, metal in the head)
- Previous participation in FES or tSCS within the past 2 years (May affect blinding integrity. Likely uncommon; FES is rarely used in Canada post-stroke.)
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06987682
Start Date
May 21 2025
End Date
December 1 2026
Last Update
July 18 2025
Active Locations (1)
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1
KITE Research Institute, Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, Canada, M4G 3V9