RECRUITINGINTERVENTIONAL

Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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.)

Treatments Being Tested

OTHER

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.

Locations (1)

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada