Last updated: February 25, 2021
Sponsor: Kessler Foundation
Overall Status: Active - Enrolling
Phase
N/A
Condition
Stroke
Cerebral Ischemia
Treatment
N/AClinical Study ID
NCT04775693
R-911-16
Ages 21-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 whilewearing the RE.
- Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (bloodpressure 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 levelconsistent with that required to participate in standard motor rehabilitation, e.g.can follow directions as determined by a Kessler Institute for Rehabilitationphysician or physical therapist.
- No history of injury or pathology to the unaffected limb.
Exclusion
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 duringambulation 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 affectweight bearing, harness fit, or therapist assistance.
- Pre-existing condition that caused exercise intolerance.(Documented uncontrolledhypertension, coronary artery disease, cardiac arrhythmia, or congestive heartfailure)
- Hospitalization for heart attack, heart surgery or acute heart failure within 3months of enrollment in study.
- Severe cognitive or psychiatric problems as well as incontinence might becontraindications to start training with a RE.
- History of severe cardiac disease such as myocardial infarction, congestive heartfailure.
- Uncontrolled seizure disorder.
- Uncontrolled spasticity that would interfere with walking in the RENeuromuscularor neurological pathologies (e.g., Parkinson's disease, spinal cord injury, ortraumatic brain injury with evidence of motor weakness and multiple sclerosis)that will interfere with neuromuscular function, ambulation, or limit the rangeof motion of the lower limbs
- Orthopedic pathologies or history that will interfere with ambulation or limitthe range of motion of the lower limbs (e.g., knee replacement, fixedcontractures, inflammation)
- Pregnant as confirmed by pregnancy test.
Study Design
Total Participants: 96
Study Start date:
May 12, 2017
Estimated Completion Date:
December 31, 2022
Connect with a study center
Kessler Foundation
West Orange, New Jersey 07052
United StatesSite Not Available
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