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

Not Applicable

Recruiting

• Conditions: C5 Palsy
• Interventions: Device: Functional electrical stimulation therapy (FES-t); Other: Conventional physiotherapy

• Registration Number: NCT05247450
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Study Start: 2023-08-16
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FES-t along with conventional physiotherapy	Conventional physiotherapy	Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training
FES-t along with conventional physiotherapy	Functional electrical stimulation therapy (FES-t)	Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training
Conventional physiotherapy alone	Conventional physiotherapy	Conventional physiotherapy alone (current standard of care)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in neurophysiological parameters	up to 10 weeks post-intervention	Neurophysiological parameters of neuroplasticity
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 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.
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)

Trial Locations

Locations (1)

KITE Toronto Research Institute; 🇨🇦 Toronto, Ontario, Canada