Status:
COMPLETED
Early FES Cycling in Acute Spinal Cord Injury for Neuromuscular Preservation and Neurorecovery
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Royal Alexandra Hospital
Glenrose Foundation
Conditions:
Acute Spinal Cord Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Spinal cord injury (SCI) is a devastating condition that often leads to paralysis and multiple health problems such as muscle wasting, bone loss and spasticity. Despite the paralysis, functional elect...
Detailed Description
Spinal cord injury (SCI) usually results in weakness or paralysis in the legs and/or arms, depending on the level and severity of the damage to the spinal cord. In addition, people with SCI often deve...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Traumatic or non-traumatic SCI
- Acute onset of SCI
- Able to start FES cycling 14-21 days post injury
- Injury level C1 - L5
- AIS A, B, C, D (ASIA Impairment Scale)
- Medically stable
- Absolute Contraindications and Exclusion Criteria
- AIS D, able to walk without assistive device
- Unstable spine fractures
- Unstable fractures/dislocations in lower extremities or pelvis
- Pregnancy
- Unable to give consent to participate in the study
- Contraindications for TMS (Transcranial Magnetic Stimulation).
- Relative Contraindications and Exclusion Criteria (Exclusion or Caution)
- Lower motor neuron injury with insufficient muscle contraction with FES
- Peripheral nerve or root injury resulting in denervated lower limb muscles
- History of severe hip or knee instability or dislocation/subluxation
- Osteoporosis in lower extremities that could result in fracture from cycling
- Osteoarthritis in lower extremities
- Limited range of motion in hip and knee preventing cycling
- History of epilepsy not effectively managed by medication
- History of heart problems (coronary artery disease / myocardial infarction / congestive heart failure)
- Implanted cardiac demand pacemaker
- Implanted stimulators: diaphragmatic, epidural, vagus nerve, phrenic
- Malignant tumor in stimulated areas
- Thrombophlebitis or thrombosis in stimulated area
- Skin lesions or open wounds at any potential electrode site
- Pressure ulcers that could deteriorate from cycling
- Spasticity
- Autonomic dysreflexia
- Active heterotopic ossification in lower extremities
- Extreme edema or adipose tissue in legs
- Any other contraindications to participate in an active exercise program
Exclusion
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05255679
Start Date
April 21 2021
End Date
October 31 2023
Last Update
September 19 2024
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1