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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06987682
• Lead Sponsor: University Health Network, Toronto

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mini-Balance Evaluation Systems Test	From enrollment to the 12-week post-intervention follow-up
Activities-specific Balance Confidence Scale	From enrollment to the 12-week post-intervention follow-up
Strength of the trunk and affected lower limb	From enrollment to the 12-week post-intervention follow-up	Via hand-held dynamometry

Secondary Outcome Measures

Name	Time	Method
Gait and standing spatiotemporal data	From enrollment to the 12-week post-intervention follow-up	Collected using the Zeno Walkway Gait Analysis System
Corticospinal excitability of the affected soleus and tibialis anterior	From enrollment to the 12-week post-intervention follow-up	TMS will be delivered using a magnetic stimulator with a double-cone coil

Trial Locations

Locations (1)

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network; 🇨🇦 Toronto, Ontario, Canada