Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
Megadott ok: The study team had been practicing running the study interventions, but the core study team members left the organization before any subjects could be enrolled. There is now insufficient personnel time dedication to this study, so it is being closed.
Key facts
- Where
- Chicago, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Shirley Ryan AbilityLabChicago, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Shirley Ryan AbilityLab
- Trial code
- NCT06169657
- Record updated
- 2025. május 25.
- Original description
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 (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.Read full original descriptionShow less
Comparison of Intensity and Step Count of Gait Training Modalities in the Inpatient Rehabilitation Setting in Sub-acute Central Nervous System Injury
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 (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.
Inclusion: 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: History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.); History of peripheral nerve injury; Unresolved deep vein thrombosis (DVT); Severe osteoporosis as indicated by physician medical clearance; Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally; Severe knee, hip, or ankle osteoarthritis; Open wounds on skin surfaces in contact with exoskeleton or harness; Unstable spine or unhealed fractures; Weight bearing precautions; 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.