C5 Palsy
Conditions
Keywords
Functional electrical stimulation therapy, Degenerative Cervical Myelopathy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFunctional electrical stimulation therapy (FES-t)
Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).
OTHERConventional physiotherapy
Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy
Sponsors
Unity Health Toronto
Sunnybrook Health Sciences Centre
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy
Exclusion criteria
* Contraindication for FES-t * Contraindication for neurophysiological testing * Contraindication for MRI scanning * Uncontrolled cardiovascular conditions * Other medical conditions that can limit treatment protocols * Other neurological diseases * Significant persisting mental illness * Diagnosed learning disabilities * Substance abuse over 6 months prior to recruitment * Hearing and visual deficits sufficient to affect test performance * Reduced passive range of motion (ROM) of the shoulder (frozen shoulder) * Inability to participate in and intensive outpatient rehabilitation program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spinal Cord Independence Measure (SCIM) score | up to 10 weeks post-intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Manual muscle testing | up to 10 weeks post-intervention | Clinical assessment of the muscle power that varies from 0 (complete paralysis) to 5 (normal) |
| change in Modified Japanese Outcome Association (mJOA) Score | up to 10 weeks post-intervention | Clinical assessment of the upper and lower extremities, and bladder function (mJOA varies from 0 \[most impaired and disabled\] to 18 \[normal function\]). |
| Change in neurophysiological parameters | up to 10 weeks post-intervention | Neurophysiological parameters of neuroplasticity |
| Change in Functional Magnetic Resonance Imaging (MRI) | 6 to10 weeks post-intervention | Functional MRI analyses will be focused on improvement of the functional connectivity within the somatosensory and motor cortices and pathways in the brain. |
Countries
Canada
Contacts
Primary ContactMitsue Aibe, MD
Backup ContactAbrity Gomes, BSc
Outcome results
None listed