Conventional-therapy & FES-therapy In-Veritas Effects Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Conventional-therapy & FES-therapy In-Veritas Effects Study (C-FIVE Study): Rehabilitation of the Upper Extremity for New Persistent C5 Palsy After Surgical Treatment of Patients With Degenerative Cervical Myelopathy

Conditions
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C5 Palsy

Intervention / Treatment
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* Device: Functional electrical stimulation therapy (FES-t)
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FES-t along with conventional physiotherapy<br>Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training | Device: Functional electrical stimulation therapy (FES-t)<br>* Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).<br>Other: Conventional physiotherapy<br>* Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy<br>* Other names: Standard of Care;|
| Active Comparator: Conventional physiotherapy alone<br>Conventional physiotherapy alone (current standard of care) | Other: Conventional physiotherapy<br>* Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional electrical stimulation therapy, Degenerative Cervical Myelopathy