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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT04775693
Eligibility Criteria:
Inclusion Criteria:
* Stroke survivors \< 4 weeks from most recent stroke.
* Age: 21- 80 years
* Unilateral hemiparesis
* Medical clearance by a Kessler Institute for Rehabilitation physician.
* Be able to physically fit into the exoskeleton device.
* Be able to tolerate upright standing for 30 minutes.
* Have joint range of motion within normal functional limits for ambulation.
* Have sufficient strength to use the hemiwalker, bilateral canes or walker while wearing the RE.
* Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in body weight support system).
* Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions as determined by a Kessler Institute for Rehabilitation physician or physical therapist.
* No history of injury or pathology to the unaffected limb.
Exclusion Criteria:
* Unable to physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
* Joint contracture or spasticity of any limb that limits normal ROM during ambulation with assistive devices.
* Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
* Skin issues that would prevent wearing the device.
* Pressure sore stage 2 or higher located in an area that would negatively affect weight bearing, harness fit, or therapist assistance.
* Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
* Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
* Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
* History of severe cardiac disease such as myocardial infarction, congestive heart failure.
* Uncontrolled seizure disorder.
* Uncontrolled spasticity that would interfere with walking in the RENeuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
* Orthopedic pathologies or history that will interfere with ambulation or limit the range of motion of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
* Pregnant as confirmed by pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04775693
Study Brief:
Protocol Section:
NCT04775693