Recruiting

Postural Control

Sponsor:

University Health Network, Toronto

Code:

NCT06987682

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balance training

Study Details

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

Study ID

NCT06987682

Start date

May 21, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Balance training + transcutaneous spinal stimulation

sham comparator: Balance training + sham transcutaneous spinal stimulation

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.

Primary outcome measure

  • Mini-Balance Evaluation Systems Test [ Time Frame: From enrollment to the 12-week post-intervention follow-up ]
  • Spinal excitability for the tibialis anterior, soleus, biceps femoris and rectus femoris [ Time Frame: From enrollment to the 12-week post-intervention follow-up ]
  • Corticospinal excitability of the affected soleus and tibialis anterior [ Time Frame: From enrollment to the 12-week post-intervention follow-up ]
  • Gait and standing spatiotemporal data [ Time Frame: From enrollment to the 12-week post-intervention follow-up ]
  • Activities-specific Balance Confidence (ABC) Scale [ Time Frame: From enrollment to the 12-week post-intervention follow-up ]
  • Lean-and-Release Test [ Time Frame: From enrollment to the 12-week post-intervention follow-up ]

Central Contacts and Locations

Central contacts

Kristin E Musselman, PhD

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

Locations

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Kristin E Musselman, PhD

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • transcutaneous spinal cord stimulation
  • postural control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-23.