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

University Health Network, Toronto

Status: Enrolling

Conditions: C5 Palsy

Treatments: Device: Functional electrical stimulation therapy (FES-t); Other: Conventional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05247450

21-5580

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

FES-t along with conventional physiotherapy

Experimental group

Description:

Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training

Treatment:

Other: Conventional physiotherapy

Device: Functional electrical stimulation therapy (FES-t)

Conventional physiotherapy alone

Active Comparator group

Description:

Conventional physiotherapy alone (current standard of care)

Treatment:

Other: Conventional physiotherapy