Conventional-therapy & FES-therapy In-Veritas Effects Study (C-FIVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: C5 Palsy
• Intervention / Treatment: Device: Functional electrical stimulation therapy (FES-t); Other: Conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mitsue Aibe, MD; Phone Number: 6285 4165973422; Email: Mitsue.Aibe@uhn.ca
• Study Contact Backup: Name: Abrity Gomes, BSc; Phone Number: 6285 4165973422; Email: Abrity.Gomes@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3V9
      • Recruiting
      • KITE Toronto Research Institute
      • Contact: Mitsue Aibe; Phone Number: 6285 4165973422; Email: Mitsue.Aibe@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Sunnybrook Health Sciences Centre; Unity Health Toronto
• Investigators: Principal Investigator: Julio C Furlan, MD,PhD, KITE-TRI, University Health Network & University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2023
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Degenerative Cervical Myelopathy; Functional electrical stimulation therapy
• Other Study ID Numbers: 21-5580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No