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

University Health Network, Toronto

Status

Enrolling

Conditions

Stroke

Treatments

Other: Balance training

Study type

Interventional

Funder types

Other

Identifiers

NCT06987682

24-5792

Details and patient eligibility

About

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 test the study plan and to find out whether enough participants will join a larger study and accept the study procedures of combining electrical stimulation with balance training.

Enrollment

16 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)