Comparing conventional physiotherapy with functional electrical stimulation therapy for C5 palsy
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
NA · University Health Network, Toronto · NCT05247450
This study tests if combining regular physiotherapy with electrical stimulation helps people with C5 palsy recover better than just using regular physiotherapy alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05247450 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of conventional physiotherapy alone versus a combination of conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training for patients with persistent C5 palsy. The study will assess improvements in functional and neurological recovery, as well as changes in neural connectivity and excitability using neurophysiological tests and functional MRI analysis. Participants will be randomly assigned to one of the two treatment groups to determine which approach yields better outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with new unilateral or bilateral persistent C5 palsy for at least three months following surgical treatment for degenerative cervical myelopathy.
Not a fit: Patients with contraindications for FES-t, neurophysiological testing, or MRI scanning, as well as those with uncontrolled cardiovascular conditions or other significant medical issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective rehabilitation strategy for patients suffering from C5 palsy, potentially leading to improved functional recovery.
How similar studies have performed: Other studies have shown promise in using functional electrical stimulation therapy for rehabilitation, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- KITE Toronto Research Institute — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Julio C Furlan, MD,PhD — KITE-TRI, University Health Network & University of Toronto
- Study coordinator: Mitsue Aibe, MD
- Email: Mitsue.Aibe@uhn.ca
- Phone: 4165973422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: C5 Palsy, Functional electrical stimulation therapy, Degenerative Cervical Myelopathy