Recruiting

Conventional & FES-therapy

Sponsor:

University Health Network, Toronto

Code:

NCT05247450

Conditions

C5 Palsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Functional electrical stimulation therapy (FES-t)

Conventional physiotherapy

Study Details

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.

Conditions

C5 Palsy

Study ID

NCT05247450

Start date

Aug 16, 2023

Status verified date

Jan, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FES-t along with conventional physiotherapy

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

active comparator: Conventional physiotherapy alone

Conventional physiotherapy alone (current standard of care)

Interventions

Functional electrical stimulation therapy (FES-t)

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

Conventional physiotherapy

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

Primary outcome measure

  • Change in Spinal Cord Independence Measure (SCIM) score [ Time Frame: up to 10 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Mitsue Aibe, MD

4165973422Mitsue.Aibe@uhn.ca

Abrity Gomes, BSc

4165973422Abrity.Gomes@uhn.ca

Locations

KITE Toronto Research Institute

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Mitsue Aibe

4165973422Mitsue.Aibe@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 11, 2024

Last verified

Jan, 2024

Keywords

  • Functional electrical stimulation therapy
  • Degenerative Cervical Myelopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-01-11.