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:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT01579604
Eligibility Criteria:
Inclusion Criteria:
* Cervical spine injury with functional loss in the upper extremity
* Greater than 4 months out from C-spine injury
* Stable motor recovery
* Medically stable
* International Classification for Surgery of the Hand in Tetraplegia of 0-5 at 6 months
* Grade 0 finger/thumb extension at 6 months
* Subjects fluent in English or when not fluent, an appropriate translator is present
Exclusion Criteria:
* Unstable patient
* Joint contracture
* Spasticity
* Loss of function is expected to be improved by reliable tendon transfer, tenodesis or arthrodesis that is available
* Evidence of recovering finger/thumb extension at 4-6 months
* Greater than 12 months from spinal cord injury
* Subject not fluent in English or an appropriate translator not available
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01579604
Study Brief:
Protocol Section:
NCT01579604