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NCT Number: NCT06987682

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KITE Research Institute, Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M4G 3V9, Canada

Location status: Recruiting

Location contact

Kristin E Musselman, PhD

CONTACT

[email protected]

416-597-3422 ext. 6190

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. Mini-Balance Evaluation Systems Test

    Time frame: From enrollment to the 12-week post-intervention follow-up

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

    Time frame: From enrollment to the 12-week post-intervention follow-up

    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).

  3. Corticospinal excitability of the affected soleus and tibialis anterior

    Time frame: From enrollment to the 12-week post-intervention follow-up

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

  4. Gait and standing spatiotemporal data

    Time frame: From enrollment to the 12-week post-intervention follow-up

    Collected using the Zeno Walkway Gait Analysis System

  5. Activities-specific Balance Confidence (ABC) Scale

    Time frame: From enrollment to the 12-week post-intervention follow-up

    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.

  6. Lean-and-Release Test

    Time frame: From enrollment to the 12-week post-intervention follow-up

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

Secondary outcomes

  1. Technology Acceptance Model Questionnaire

    Time frame: Immediately post-intervention

    A questionnaire exploring participants' perceptions of transcutaneous spinal cord stimulation combined with reactive balance training. Participants are asked to rate each statement (e.g. I enjoyed using electrical stimulation combined with balance training) on a 5-point Likert scale with the following options: Strongly disagree, Disagree, Neutral, Agree, Strongly Agree. A mean score and SD for each section will be calculated. A higher score represents greater perceived usefulness, ease of use and efficacy of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin E Musselman, PhD

CONTACT

[email protected]

416-597-3422 ext. 6190

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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