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Physiotherapy + FES for Cervical Radiculopathy (C-FIVE Trial)

N/A

Recruiting

Led By Julio C Furlan, MD,PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to10 weeks post-intervention

Awards & highlights

C-FIVE Trial Summary

This trial will compare the effectiveness of physiotherapy alone versus physiotherapy with electrical stimulation and task-specific training for patients with C5 palsy.

Who is the study for?

This trial is for people who have had persistent C5 palsy for at least 3 months after neck surgery. It's not suitable for those with substance abuse issues, other medical conditions that limit treatment, contraindications to FES-t, severe mental illness, learning disabilities, or uncontrolled heart problems.Check my eligibility

What is being tested?

The study is testing if adding Functional Electrical Stimulation therapy (FES-t) to conventional physiotherapy helps improve movement and nerve function in patients with C5 palsy more than physiotherapy alone.See study design

What are the potential side effects?

While the side effects are not detailed here, typical ones from physical therapies may include muscle soreness or fatigue. FES-t might cause skin irritation or discomfort where the electrical pads are placed.

C-FIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had persistent arm weakness for 3 months after neck surgery.

C-FIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to10 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 to10 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to10 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Spinal Cord Independence Measure (SCIM) score

Secondary outcome measures

Change in Functional Magnetic Resonance Imaging (MRI)

Change in Manual muscle testing

Change in neurophysiological parameters

+1 more

C-FIVE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FES-t along with conventional physiotherapyExperimental Treatment2 Interventions

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

Group II: Conventional physiotherapy aloneActive Control1 Intervention

Conventional physiotherapy alone (current standard of care)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,977 Total Patients Enrolled

Unity Health TorontoOTHER

539 Previous Clinical Trials

447,749 Total Patients Enrolled

Sunnybrook Health Sciences CentreOTHER

656 Previous Clinical Trials

1,551,426 Total Patients Enrolled

Media Library

Conventional physiotherapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05247450 — N/A

Cervical Radiculopathy Research Study Groups: FES-t along with conventional physiotherapy, Conventional physiotherapy alone

Cervical Radiculopathy Clinical Trial 2023: Conventional physiotherapy Highlights & Side Effects. Trial Name: NCT05247450 — N/A

Conventional physiotherapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05247450 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide information about the current eligibility for this experiment?

"Clinicaltrials.gov reveals that the recruitment phase of this trial is still ongoing; it was first announced on 16th August 2022 and has been modified since then."

Answered by AI

How many participants are currently taking part in this experiment?

"Affirmative. Clinicaltrials.gov reveals this clinical trial is recruiting participants, first posted on August 16th 2022 and last updated the same day. The trial seeks to recruit sixteen people from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Conventional-therapy & FES-therapy In-Veritas Effects Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05247450.