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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT05615766
Eligibility Criteria:
Inclusion Criteria:
* Age 18+ years.
* The levels of C5 C6 Asia C/D would provide individuals with elbow and hand impairment and potentially functional shoulder movements. C7, C8 individuals could also benefit from the hand component of the device.
* Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest potential for functional change.
* Preservation of hand sensation as base for motor restoration.
* Some sitting balance would give the best opportunity for the arm to be released for functional upper limb activity.
* EMG (muscle activity) evidence of active finger flexion, extension and elbow flexion extension Grade 1-2.
* Minimal or No community functional use of upper limb at start of trial.
* Spasticity MAS 1-3/5.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05615766
Study Brief:
Protocol Section:
NCT05615766