Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury

NCT06169657 | Withdrawn FDA Device

• 1 other identifier: STU00219486
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Incomplete Spinal Cord Injury

Keywords

Stroke; Incomplete Spinal Cord Injury; Gait Rehabilitation; Exoskeleton; Balance

Outcome Measures

Primary Outcomes (4)

• Observation of Step count

  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

  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

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

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 training; Device: 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 training; Device: 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); 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 training; Device: Overground gait training

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 ambulators; Inpatients Post-stroke, low level ambulators; Inpatients with iSCI, high level ambulators; Inpatients with iSCI, low level ambulators

EksoNR exoskeleton gait training DEVICE

Walking in the EksoNR exoskeleton

Inpatients Post-stroke, high level ambulators; Inpatients Post-stroke, low level ambulators; Inpatients with iSCI, high level ambulators; Inpatients with iSCI, low level ambulators

Overground gait training DEVICE

Walking overground in a harness with body weight support as needed

Inpatients Post-stroke, high level ambulators; Inpatients Post-stroke, low level ambulators; Inpatients with iSCI, high level ambulators; Inpatients with iSCI, low level ambulators

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals poststroke or post-iSCI that are inpatients at Shirley Ryan AbilityLab

You may qualify if:

• 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
• 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:

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose L Pons, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: September 1, 2024
• Primary Completion: November 25, 2024
• Study Completion: December 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)