Menu
Not yet recruiting NCT04910204

Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals with Traumatic SCI

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FES Therapy combined with task-specific training (FEST+TST).
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Time Sensitivity of Adaptive Neuroplasticity and Functional Recovery Related to FEST in Combination with TST for Rehabilitation of Upper Extremity Function of Individuals with Tetraplegia

Overview

The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific training (FEST+TST) following spinal cord injury (SCI) influences functional and neurological recovery.

Interventions

  • Other FES Therapy combined with task-specific training (FEST+TST)
    The FEST+TST protocol consists of a 1-hour session, 3 to 5 days a week, for up to 12 weeks (40 sessions total) in addition to conventional occupational and physical therapies according to the standard of care.

Primary outcome measures

  • Spinal Cord Independence Measure (SCIM) [Time frame: Change from baseline SCIM at 3 & 6 months]
  • American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS) [Time frame: Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])]
  • ASIA Upper-Extremity Sensory Score (UESS) [Time frame: Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])]
  • Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) [Time frame: Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])]
Secondary outcome measures (10)
  • Needle Electromyography [Time frame: Change in baseline EMG activity at 3 & 6 months]
  • Repetitive Nerve Stimulation [Time frame: Change in baseline neuromuscular junction transmission at 3 & 6 months]
  • Nerve Conduction Studies [Time frame: Change in baseline nerve conduction at 3 & 6 months]
  • F-Wave [Time frame: Change in baseline F-wave amplitude at 3 & 6 months]
  • H-Reflex [Time frame: Change in baseline H-reflex amplitude at 3 & 6 months]
  • Somatosensory Evoked Potentials (SSEPs) [Time frame: Change in baseline SSEPs at 3 & 6 months]
  • Motor Evoked Potentials (MEPs) [Time frame: Change in baseline MEPs at 3 & 6 months]
  • Functional Magnetic Resonance Imaging (fMRI) [Time frame: Change in baseline functional connectivity at 3 & 6 months]
  • Laboratorial Assessments (BDNF) [Time frame: Change in baseline BDNF at 3 & 6 months]
  • Laboratorial Assessments (NTF-3) [Time frame: Change in baseline NTF-3 at 3 & 6 months]

Eligibility criteria

Inclusion criteria

  • Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI

Exclusion criteria

  • Contraindications for neurophysiological tests
  • Contraindications for FEST
  • Medical conditions that can limit treatment protocols
  • Other neurological diseases (i.e. peripheral neuropathies)
  • Significant persisting mental illness;
  • Learning disabilities;
  • Substance abuse over 6 months prior to recruitment;
  • Hearing and visual deficits sufficient to affect test performance;
  • Contraindication to MRI scanning

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Lyndhurst Centre, KITE - TRI UHN — Toronto

Identifiers

NCT: NCT04910204 · 19-6286

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗