Clinical trial NCT05247450: Conventional-therapy & FES-therapy In-Veritas Effects Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: C5 Palsy
Keywords: Functional electrical stimulation therapy
Degenerative Cervical Myelopathy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Sunnybrook Health Sciences Centre
First posted: 2022-02-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Spinal Cord Independence Measure (SCIM) score
timeFrame: up to 10 weeks post-intervention
Secondary outcomes:
measure: Change in Manual muscle testing
timeFrame: up to 10 weeks post-intervention
measure: change in Modified Japanese Outcome Association (mJOA) Score
timeFrame: up to 10 weeks post-intervention
measure: Change in neurophysiological parameters
timeFrame: up to 10 weeks post-intervention
measure: Change in Functional Magnetic Resonance Imaging (MRI)
timeFrame: 6 to10 weeks post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE Toronto Research Institute
state: Ontario
Study officials:
affiliation: KITE-TRI, University Health Network & University of Toronto
name: Julio C Furlan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: