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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
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This randomized clinical trial will primarily compare the effectiveness of conventional physiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy.
This randomized clinical trial will primarily compare the effectiveness of conventionalphysiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy. Secondarily, this clinical trial will evaluate the effectiveness of combined conventional physiotherapy and FES-t along with task-specific training outcome compared to conventional physiotherapy alone with regards to improved connectivity andexcitability in the ascending and descending pathways as assessed using neurophysiological tests and functional MRI analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES-t along with conventional physiotherapy | Experimental | Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training |
|
| Conventional physiotherapy alone | Active Comparator | Conventional physiotherapy alone (current standard of care) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional electrical stimulation therapy (FES-t) | Device | Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spinal Cord Independence Measure (SCIM) score | The SCIM is a clinician-administered disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently (SCIM varies from 0 (completely dependent) to 100 (completely independent). | up to 10 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Manual muscle testing | Clinical assessment of the muscle power that varies from 0 (complete paralysis) to 5 (normal) | up to 10 weeks post-intervention |
| change in Modified Japanese Outcome Association (mJOA) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitsue Aibe, MD | Contact | 4165973422 | 6285 | Mitsue.Aibe@uhn.ca |
| Abrity Gomes, BSc | Contact | 4165973422 | 6285 | Abrity.Gomes@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Julio C Furlan, MD,PhD | KITE-TRI, University Health Network & University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KITE Toronto Research Institute | Recruiting | Toronto | Ontario | M4G 3V9 | Canada |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Conventional physiotherapy | Other | Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy |
|
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Clinical assessment of the upper and lower extremities, and bladder function (mJOA varies from 0 [most impaired and disabled] to 18 [normal function]).
| up to 10 weeks post-intervention |
| Change in neurophysiological parameters | Neurophysiological parameters of neuroplasticity | up to 10 weeks post-intervention |
| Change in Functional Magnetic Resonance Imaging (MRI) | Functional MRI analyses will be focused on improvement of the functional connectivity within the somatosensory and motor cortices and pathways in the brain. | 6 to10 weeks post-intervention |