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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01974635
Eligibility Criteria:
Inclusion Criteria:
* Traumatic incomplete SCI, stroke or acquired brain injured ABI subjects.
* Able to tolerate sitting upright at for at least 1 hour.
* Significant, but not complete, motor deficit in the hand and wrist, as determined by the Study Physician performing the screening.
* Significant, but not complete somatosensory deficit in the hand and wrist as determined by the Study Physician performing the screening.
* Cognitively and behaviorally capable of complying with the regimen.
Exclusion Criteria:
* Fracture of the treated limb resulting in loss of range of motion.
* Progressive neurodegenerative disorder.
* DVT of the treated extremity.
* Uncontrolled seizure disorder.
* Uncontrolled high blood pressure/angina.
* Osteo- or rheumatoid arthritis limiting range of motion
* Contractures equal to or greater than 50% of the normal ROM.
* Chronic ITB therapy.
* Peripheral nerve injury of the treated extremity.
* Pain in affected limb or exercise intolerance.
* Participation in another therapy or activity-based program.
* Skin condition not tolerant of device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01974635
Study Brief:
Protocol Section:
NCT01974635