Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT02554058
Eligibility Criteria:
Inclusion Criteria:
* The participant should have experienced a traumatic spinal cord injury
* American Spinal Injury Association (ASIA) class C or D
* Between 18 and 65 years
* At least 12 months post- injury to ensure stability of the patient's neurological condition
* Should be able to walk 10 meters or more with or without assistance (use of braces or walking aids or parallel bars or moderate assistance of one person)
* Should have range of motion in the lower limb joint sufficient to allow the cycling exercise
* Discharged from all rehabilitation.
Exclusion Criteria:
* Impaired mental capacity
* Any medical contradiction to cycling training
* Degenerative spinal disorder
* Significant diagnosed osteoporosis
* Excessive spasticity in the legs as measured by a score of more than 3 on the Modified Ashworth Scale or any spasticity that limits the possibility of cycling exercise or walking
* Obstructive and/or restrictive pulmonary disease
* Severe spinal and Lower Limb deformities
* Decubitus ulcer in the area in contact with the bike and bike's bed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02554058
Study Brief:
Protocol Section:
NCT02554058