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

NCT ID: NCT05247450

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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C5 Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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FES-t along with conventional physiotherapy

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

Group Type EXPERIMENTAL

Conventional physiotherapy

Intervention Type OTHER

Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy

Functional electrical stimulation therapy (FES-t)

Intervention Type DEVICE

Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).

Conventional physiotherapy alone

Conventional physiotherapy alone (current standard of care)

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type OTHER

Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy

Interventions

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Conventional physiotherapy

Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy

Intervention Type OTHER

Functional electrical stimulation therapy (FES-t)

Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).

Intervention Type DEVICE

Other Intervention Names

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Standard of Care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julio C Furlan, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

KITE-TRI, University Health Network & University of Toronto

Locations

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KITE Toronto Research Institute

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mitsue Aibe, MD

Role: CONTACT

4165973422 ext. 6285

Abrity Gomes, BSc

Role: CONTACT

4165973422 ext. 6285

Facility Contacts

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Mitsue Aibe

Role: primary

4165973422 ext. 6285

Other Identifiers

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21-5580

Identifier Type: -

Identifier Source: org_study_id

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