C5 PalsyC-FIVENCT05247450
Conventional-therapy & FES-therapy In-Veritas Effects Study
A study testing Functional electrical stimulation therapy (FES-t) and Conventional physiotherapy in people with C5 Palsy, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C5 Palsy
- What is being tested?
- Functional electrical stimulation therapy (FES-t) and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
KITE Toronto Research Institute
Toronto, Ontario, M4G 3V9
Mitsue Aibe, 4165973422 ext. 6285, Mitsue.Aibe@uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- C5 Palsy
- Being tested
- Functional electrical stimulation therapy (FES-t), Conventional physiotherapy
- Keywords
- Functional electrical stimulation therapy, Degenerative Cervical Myelopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulation therapy (FES-t)Device
Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).
Conventional physiotherapyOther
Also called Standard of Care
Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy
| Study group | Role | What they receive |
|---|---|---|
| FES-t along with conventional physiotherapy | Experimental | Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training Receives: Device: Functional electrical stimulation therapy (FES-t); Other: Conventional physiotherapy |
| Conventional physiotherapy alone | Active comparator | Conventional physiotherapy alone (current standard of care) Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 10 weeks post-intervention
Secondary outcomes (4)
Change in Manual muscle testing
Clinical assessment of the muscle power that varies from 0 (complete paralysis) to 5 (normal)
Measured: 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]).
Measured: up to 10 weeks post-intervention
Change in neurophysiological parameters
Neurophysiological parameters of neuroplasticity
Measured: 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.
Measured: 6 to10 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start16 Aug 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C5 PalsyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Julio C Furlan, MD,PhD, Principal investigator, KITE-TRI, University Health Network & University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247450
- Sponsor's protocol ID
- 21-5580
- Acronym
- C-FIVE
- Status last verified
- Jan 2024
- First submitted
- 29 Oct 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05247450
- Acronym / sponsor ID
- C-FIVE / 21-5580
- Conditions
- C5 Palsy
- Keywords
- Functional electrical stimulation therapy, Degenerative Cervical Myelopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Sunnybrook Health Sciences Centre
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES-t along with conventional physiotherapy | Experimental | Device: Functional electrical stimulation therapy (FES-t), Other: Conventional physiotherapyCombined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training |
| Conventional physiotherapy alone | Active comparator | Other: Conventional physiotherapyConventional physiotherapy alone (current standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy
Key exclusion criteria (12 listed)
- Contraindication for FES-t
- Contraindication for neurophysiological testing
- Contraindication for MRI scanning
- Uncontrolled cardiovascular conditions
- Other medical conditions that can limit treatment protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional electrical stimulation therapy (FES-t)Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device). | Device | FES-t along with conventional physiotherapy |
| Conventional physiotherapyAlso: Standard of CareConventional physiotherapy is the current standard of care for rehabilitation of C5 palsy | Other | Conventional physiotherapy alone, FES-t along with conventional physiotherapy |
Primary outcome
Change in Spinal Cord Independence Measure (SCIM) score
Time frame: 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).
4 secondary outcomes
Change in Manual muscle testing
Time frame: up to 10 weeks post-intervention
change in Modified Japanese Outcome Association (mJOA) Score
Time frame: up to 10 weeks post-intervention
Change in neurophysiological parameters
Time frame: up to 10 weeks post-intervention
Change in Functional Magnetic Resonance Imaging (MRI)
Time frame: 6 to10 weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for C5 Palsy
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Recruiting
Can Prophylactic Foraminotomy Prevent C5 Palsy
Myelopathy, Compressive, Radiculopathy, Cervical
Recruiting
Neuromodulation With Spinal Stimulation Methods
Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio C Furlan, MD,PhD principal investigator
KITE-TRI, University Health Network & University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulation therapy (FES-t) and Conventional physiotherapy in people with C5 Palsy, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitsue Aibe, MD (4165973422 ext. 6285, Mitsue.Aibe@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spinal Cord Independence Measure (SCIM) score (time frame: up to 10 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.