Lower Limb Function After Spinal Cord Injury

Completed · Phase 4 · Has a placebo group

Conditions studied: Spinal Cord Injury

In brief

This is a randomized, experimental study that examines the physiology of central nervous system pathways contributing to the control of bilateral movements in individuals with spinal cord injuries and promotes the recovery of lower-limb motor function through the use of stimulation and locomotor training.

Key facts

Study ID

NCT02635893

Run by

Shirley Ryan AbilityLab

People needed

257

Starts

2019-06-21

Expected to finish

2021-04-11

Last updated by the study team

2021-07-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 4. Inclusion criteria for individuals with SCI:
• Male and females between ages 18-85 years of age
• SCI ( ≥1 month of injury)
• ASIA A, B,C and D
• SCI above L5
• Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
• Able to ambulate a few steps with or without an assistive device
• Inclusion criteria for healthy controls:
• Male and females between ages 18-85 years of age
• Able to walk and complete lower-limb tests with both legs

You may not qualify if…

• Exclusion criteria for individuals with SCI
• Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
• Any debilitating disease prior to the SCI that caused exercise intolerance
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke,
• Metal plate in skull
• History of seizures
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
• Pregnant females, and
• Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.
• Exclusion criteria for healthy controls:
• Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
• Any debilitating disease that causes exercise intolerance
• Premorbid, ongoing major depression or psychosis, altered cognitive status
• History of head injury or stroke,
• Metal plate in skull
• History of seizures
• Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
• Pregnant females, and
• Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.

Where it is running

• The Shirley Ryan Ability Lab — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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