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.
Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
Comparison of Intensity and Step Count of Gait Training Modalities in the Inpatient Rehabilitation Setting in Sub-acute Central Nervous System Injury
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 25, 2024
Actual (reported)
Study Completion
December 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 (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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
withdrawn
Actual enrollment (reported)
0 participants
Study completion date
December 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
December 5, 2023
Actual (reported)
First Posted
December 13, 2023
Actual (reported)
Study Start
September 1, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 25, 2024
Actual (reported)
Study Completion
December 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
The number of steps taken during each session will be measured using activity monitors/pedometers. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion. A higher step count is a better outcome.
Each session through completion of study, up to 10 days
Observation of Time spent in age-predicted maximum high-intensity target heart rate zone
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - \[0.7 × age\] as developed by Tanka et al in 2001. The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. More time spent in the maximum intensity zone target zone is a better outcome.
Each session through completion of study, up to 10 days
Observation of Time spent in age-predicted moderate-intensity target heart rate zone
Secondary Outcomes (8)
Observation of Minutes spent in equipment setup per session
Each session through completion of study, up to 10 days
Observation of Minutes spent in rest breaks per session
Each session through completion of study, up to 10 days
Observation of Minutes spent stepping
Each session through completion of study, up to 10 days
Observation of Patient Borg Rating of perceived exertion (RPE)
Each session through completion of study, up to 10 days
Observation of Patient Intrinsic Motivation Inventory (IMI)
Each session through completion of study, up to 10 days
+3 more secondary outcomes
Study Arms (4)
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
Device: Body-weight-supported treadmill training (BWSTT)Device: EksoNR exoskeleton gait trainingDevice: Overground gait training
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
Device: Body-weight-supported treadmill training (BWSTT)Device: EksoNR exoskeleton gait trainingDevice: Overground gait training
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
Device: Body-weight-supported treadmill training (BWSTT)
Interventions
Body-weight-supported treadmill training (BWSTT)Device
Walking on a treadmill in a harness with body weight support as needed
Inpatients Post-stroke, high level ambulatorsInpatients Post-stroke, low level ambulatorsInpatients with iSCI, high level ambulatorsInpatients with iSCI, low level ambulators
EksoNR exoskeleton gait trainingDevice
Eligibility Criteria
Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population
Individuals poststroke or post-iSCI that are inpatients at Shirley Ryan AbilityLab
The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - \[0.7 × age\] as developed by Tanka et al in 2001. The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the moderate intensity pre-calculated target zone is a better outcome as the more minutes in the high intensity zone is the best outcome.
Each session through completion of study, up to 10 days
Observation of Time spent in age-predicted low-intensity target heart rate zone
The target range of 50% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - \[0.7 × age\] as developed by Tanka et al in 2001. Low intensity equals 50% or less of age-predicted maximum heart rate and will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the low intensity zone is better as the goal is to achieve more minutes in high-intensity zone.
Each session through completion of study, up to 10 days
Device: EksoNR exoskeleton gait training
Device: Overground gait training
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
Device: Body-weight-supported treadmill training (BWSTT)Device: EksoNR exoskeleton gait trainingDevice: Overground gait training
Walking in the EksoNR exoskeleton
Inpatients Post-stroke, high level ambulatorsInpatients Post-stroke, low level ambulatorsInpatients with iSCI, high level ambulatorsInpatients with iSCI, low level ambulators
Overground gait trainingDevice
Walking overground in a harness with body weight support as needed
Inpatients Post-stroke, high level ambulatorsInpatients Post-stroke, low level ambulatorsInpatients with iSCI, high level ambulatorsInpatients with iSCI, low level ambulators
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
You may not qualify if:
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
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:
+15 more criteria
Contact the study team to confirm eligibility.
Primary Completion
November 25, 2024
Actual (reported)
Study Completion
December 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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