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

NCT ID: NCT06987682

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2027-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Balance training + transcutaneous spinal stimulation

Group Type: EXPERIMENTAL

Balance training

Intervention Type: OTHER

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.

Balance training + sham transcutaneous spinal stimulation

Group Type: SHAM_COMPARATOR

Balance training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kristin E Musselman, PhD

Role: CONTACT

kristin.musselman@uhn.ca

416-597-3422 ext. 6190

Facility Contacts

Kristin E Musselman, PhD

Role: primary

kristin.musselman@uhn.ca

416-597-3422 ext. 6190

Other Identifiers

24-5792

Identifier Type: -

Identifier Source: org_study_id