Stroke
Conditions
Keywords
transcutaneous spinal cord stimulation, postural control
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.
Interventions
OTHERBalance 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 |
| Gait and standing spatiotemporal data | From enrollment to the 12-week post-intervention follow-up | Collected using the Zeno Walkway Gait Analysis System |
| Activities-specific Balance Confidence (ABC) Scale | 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. |
| Lean-and-Release Test | 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
| Measure | Time frame | Description |
|---|---|---|
| Technology Acceptance Model Questionnaire | 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. |
Countries
Canada
Contacts
CONTACTKristin E Musselman, PhD
Outcome results
None listed