Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Balance training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other 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 measures
- 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]
Secondary outcome measures (1)
- Technology Acceptance Model Questionnaire [Time frame: Immediately post-intervention]
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- KITE Research Institute, Toronto Rehabilitation Institute - University Health Network — Toronto
Identifiers
NCT: NCT06987682 · 24-5792