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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT03701594
Eligibility Criteria:
Inclusion Criteria:
* Individuals diagnosed with traumatic brain injury admitted to the Shirley Ryan AbilityLab (SRALab)
* Age 18 or older
* Able and willing to give written consent or has an identified medical proxy willing to give written consent on behalf of the individual
* Able to follow commands consistently with a reasonable amount of verbal or visual cues in order to participate in a 60-minute physical therapy session in a group setting
* Able to attend to a task with reasonable amount of verbal or visual cues in order to participate in a 60-minute physical therapy session in a group setting
* Behaviorally appropriate for a group setting in terms of verbal or physical escalation/aggression
Exclusion Criteria:
* Serious cardiac conditions (arrhythmias) or neurological comorbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
* Pregnant or nursing
* Skin allergies or irritation; open wounds in the areas that the sensors would be applied to
* Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
* Non-English speaking patients, due to necessity for an interpreter to be present constantly interpreting, which could impact the low-stimulation setting of the intervention
* Aphasia or any difficulties in accurately self-reporting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03701594
Study Brief:
Protocol Section:
NCT03701594