Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
NCT ID: NCT06169657
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-09-01
2025-12-31
Brief Summary
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Detailed Description
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The gait training modalities assessed will include BWSTT, overground gait training with a lower extremity exoskeleton, and overground gait training with BWS. The participants' functional level will be classified by gait speed obtained via the 10 meter walk test (10MWT), a standardized assessment commonly used in rehabilitation. These functional classification categories include household ambulator (low level) and limited community ambulator (high level), determined by Fritz et al. 2009.
The researchers hypothesize that low functioning/household ambulators will achieve more minutes in high-intensity training zones utilizing the exoskeleton due to the enhanced participation and increased weight-bearing the device supports compared to the other modalities. In addition, a greater number steps will be achieved in this mode due to the exoskeleton's ability to decrease overall therapist burden compared to BWSTT and overground with BWS. In contrast, the researchers anticipate that steps per session and overall intensity will be decreased in high functioning/limited community ambulators due the unnecessary support the exoskeleton provides at this functional level. The researchers believe that high functioning/ limited community ambulators will achieve the highest number of steps and intensity during BWSTT due to the ability to increase challenges via treadmill parameters such as speed and incline while utilizing a harness for safety and bodyweight support only as necessary. In contrast, the researchers believe the amount of BWS and assistance a PT must provide relative to the patient's contribution to practice successful stepping during BWSTT will result in a lower intensity and number of steps achieved in low functioning/household ambulators.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Inpatients Post-stroke, low level ambulators
Individuals post acute or subacute stroke that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.0-0.39 m/s
Body-weight-supported treadmill training (BWSTT)
Walking on a treadmill in a harness with body weight support as needed
EksoNR exoskeleton gait training
Walking in the EksoNR exoskeleton
Overground gait training
Walking overground in a harness with body weight support as needed
Inpatients Post-stroke, high level ambulators
Individuals post acute or subacute stroke that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.4-0.79 m/s
Body-weight-supported treadmill training (BWSTT)
Walking on a treadmill in a harness with body weight support as needed
EksoNR exoskeleton gait training
Walking in the EksoNR exoskeleton
Overground gait training
Walking overground in a harness with body weight support as needed
Inpatients with iSCI, low level ambulators
Individuals post-SCI or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.0-0.39 m/s
Body-weight-supported treadmill training (BWSTT)
Walking on a treadmill in a harness with body weight support as needed
EksoNR exoskeleton gait training
Walking in the EksoNR exoskeleton
Overground gait training
Walking overground in a harness with body weight support as needed
Inpatients with iSCI, high level ambulators
Individuals post-SCI or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.4-0.79 m/s
Body-weight-supported treadmill training (BWSTT)
Walking on a treadmill in a harness with body weight support as needed
EksoNR exoskeleton gait training
Walking in the EksoNR exoskeleton
Overground gait training
Walking overground in a harness with body weight support as needed
Interventions
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Body-weight-supported treadmill training (BWSTT)
Walking on a treadmill in a harness with body weight support as needed
EksoNR exoskeleton gait training
Walking in the EksoNR exoskeleton
Overground gait training
Walking overground in a harness with body weight support as needed
Eligibility Criteria
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Inclusion Criteria
* 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
* First stroke, ischemic or hemorrhagic, within the past six months
* Unilateral, supratentorial stroke
* ASIA C or D
* Traumatic iSCI, within past six months
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Jose Pons
Principal Investigator
Principal Investigators
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Jose L Pons, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00219486
Identifier Type: -
Identifier Source: org_study_id
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