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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT03184792
Eligibility Criteria:
Inclusion Criteria:
* Cervical (C7 or higher) spinal cord injury at least 1-year duration
* Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D)
* Between 21 and 70 years of age
* Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)
* Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities
* Capable of performing simple cued motor tasks
* Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities
* Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period.
* Ability to read and speak English
Exclusion Criteria:
* Autoimmune etiology of spinal cord dysfunction/injury
* History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
* Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
* Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
* Significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
* Active cancer
* Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
* Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities
* Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
* Pregnancy
* Tendon or nerve transfer surgery in the upper limbs
* Botulinum toxin injections in the prior 6 months
* Dependent on ventilation support
* Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc).
* Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire
* Diagnosed with syringomyelia
* Alcohol and/or drug abuse.
* Cognitive impairment based on Short Portable Mental Status Questionnaire
* Unable to read and/or comprehend the consent form.
* Unable to understand the instructions given as part of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03184792
Study Brief:
Protocol Section:
NCT03184792