Status:
WITHDRAWN
Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
Lead Sponsor:
Shirley Ryan AbilityLab
Conditions:
Stroke
Incomplete Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (...
Detailed Description
Aim 1 of this study is to measure stepping repetition and intensity via heart rate of three gait-training modalities utilized with patients in the subacute phase of stroke and iSCI during inpatient re...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 18-75 years old, inclusive
- Medical clearance from primary medical team (signed Medical Clearance form)
- Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
- Gait speed between 0-0.79 m/s
- Informed consent provided by participant or POA
- English speaking
- Additional Inclusion Criteria for patients post-stroke:
- First stroke, ischemic or hemorrhagic, within the past six months
- Unilateral, supratentorial stroke
- Additional Inclusion Criteria for patients iSCI:
- ASIA C or D
- Traumatic iSCI, within past six months
- Exclusion Criteria
- Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
- History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.)
- History of peripheral nerve injury
- Severe knee, hip, or ankle osteoarthritis
- Severe osteoporosis as indicated by physician medical clearance
- Open wounds on skin surfaces in contact with exoskeleton or harness
- Unstable spine or unhealed fractures
- Weight bearing precautions
- Unresolved deep vein thrombosis (DVT)
- Pregnancy
- Prisoners
- Additional Exclusion criteria for EksoNR13:
- Weight \>220 lbs (100 kg)
- Height below 60 inches or above 76 inches
- Standing hip width of approximately 18 inches or more
- Joint contractures or range of motion deficits that limit normal range of motion during ambulation:
- Knee flexion contracture greater than 12°
- Hip flexion contracture greater than 17°
- Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12°
- Bilateral hip flexion less than 110°
- Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- Leg length discrepancy:
- Greater than 0.5 in. (1.27 cm) for upper legs
- Greater than 0.75 in. (1.91 cm) for lower legs
- Active heterotopic ossification
- Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- High anxiety or claustrophobia
- Clostridium difficile or other gastrointestinal isolation precautions
- Colostomy
- Uncontrolled autonomic dysreflexia
- Lower limb prosthesis
Exclusion
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06169657
Start Date
September 1 2024
End Date
December 31 2025
Last Update
May 25 2025
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611