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

NCT06987682 | Recruiting

• 1 other identifier: 24-5792
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke

Keywords

transcutaneous spinal cord stimulation; postural control

Outcome Measures

Primary Outcomes (6)

• Mini-Balance Evaluation Systems Test

  From enrollment to the 12-week post-intervention follow-up

• Spinal excitability for the tibialis anterior, soleus, biceps femoris and rectus femoris

  To assess spinal excitability, double-pulse TSCS will be applied. Spinal motor thresholds will first be determined for each of the following muscles on the affected side: tibialis anterior (TA), soleus (SOL), biceps femoris (BF), and rectus femoris (RF).

  From enrollment to the 12-week post-intervention follow-up

• Corticospinal excitability of the affected soleus and tibialis anterior

  TMS will be delivered using a magnetic stimulator with a double-cone coil

  From enrollment to the 12-week post-intervention follow-up

• Gait and standing spatiotemporal data

  Collected using the Zeno Walkway Gait Analysis System

  From enrollment to the 12-week post-intervention follow-up

• Activities-specific Balance Confidence (ABC) Scale

  Items are rated on a scale from 0-100% confidence. Sixteen items of the standard ABC are used to calculate a mean. Five personalized items (i.e. tasks of important to each individual participant) are used to calculate a separate mean. The minimum score is 0%, the maximum score is 100%; the higher the score, the greater the confidence.

  From enrollment to the 12-week post-intervention follow-up

• Lean-and-Release Test

  A test of reactive balance in the forward direction. Observational and kinematic (i.e. force plate, marker) data are collected.

  From enrollment to the 12-week post-intervention follow-up

Secondary Outcomes (1)

• Technology Acceptance Model Questionnaire

  Immediately post-intervention

Study Arms (2)

Balance training + transcutaneous spinal stimulation

EXPERIMENTAL

Other: Balance training

Balance training + sham transcutaneous spinal stimulation

SHAM COMPARATOR

Other: Balance training

Interventions

Balance training 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; Balance training + transcutaneous spinal stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kristin E Musselman, PhD

CONTACT

416-597-3422; kristin.musselman@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary objective is to describe and compare clinical, biomechanical and neurophysiological outcomes between individuals with stroke who receive reactive balance training (RBT) with transcutaneous spinal cord stimulation (tSCS) and those who receive RBT with sham tSCS. The secondary objective is to determine the acceptability of a balance intervention combined with tSCS.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CA (1)