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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balance training + transcutaneous spinal stimulation | Experimental |
| |
| Balance training + sham transcutaneous spinal stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technology Acceptance Model Questionnaire | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin E Musselman, PhD | Contact | 416-597-3422 | 6190 | kristin.musselman@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KITE Research Institute, Toronto Rehabilitation Institute - University Health Network | Recruiting | Toronto | Ontario | M4G 3V9 | Canada |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Immediately post-intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |