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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16
Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).
Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy
KITE Toronto Research Institute
Toronto, Ontario, Canada
RECRUITINGChange 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).
Time frame: up to 10 weeks post-intervention
Change in Manual muscle testing
Clinical assessment of the muscle power that varies from 0 (complete paralysis) to 5 (normal)
Time frame: up to 10 weeks post-intervention
change in Modified Japanese Outcome Association (mJOA) Score
Clinical assessment of the upper and lower extremities, and bladder function (mJOA varies from 0 \[most impaired and disabled\] to 18 \[normal function\]).
Time frame: up to 10 weeks post-intervention
Change in neurophysiological parameters
Neurophysiological parameters of neuroplasticity
Time frame: 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.
Time frame: 6 to10 weeks post-intervention
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