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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    C5 Palsy

NCT05247450

University Health Network, Toronto

28 January 2024

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