NCT05247450

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 16, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

October 29, 2021

Last Update Submit

January 10, 2024

Conditions

C5 Palsy

Keywords

Functional electrical stimulation therapyDegenerative Cervical Myelopathy

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to 10 weeks post-intervention

Secondary Outcomes (4)

  • Change in Manual muscle testing

    up to 10 weeks post-intervention

  • change in Modified Japanese Outcome Association (mJOA) Score

    up to 10 weeks post-intervention

  • Change in neurophysiological parameters

    up to 10 weeks post-intervention

  • Change in Functional Magnetic Resonance Imaging (MRI)

    6 to10 weeks post-intervention

Study Arms (2)

FES-t along with conventional physiotherapy

EXPERIMENTAL

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

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

Conventional physiotherapy alone

ACTIVE COMPARATOR

Conventional physiotherapy alone (current standard of care)

Other: Conventional physiotherapy

Interventions

Functional electrical stimulation therapy (FES-t)DEVICE

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

FES-t along with conventional physiotherapy
Conventional physiotherapyOTHER

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

Also known as: Standard of Care
Conventional physiotherapy aloneFES-t along with conventional physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KITE Toronto Research Institute

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Julio C Furlan, MD,PhD

    KITE-TRI, University Health Network & University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitsue Aibe, MD

CONTACT

4165973422Mitsue.Aibe@uhn.ca

Abrity Gomes, BSc

CONTACT

4165973422Abrity.Gomes@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

February 18, 2022

Study Start

August 16, 2023

Primary Completion

August 30, 2025

Study Completion

December 31, 2025

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations

CA(1)