Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training
NCT ID: NCT06478680
Last Updated: 2025-07-11
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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TERMINATED
NA
3 participants
INTERVENTIONAL
2024-10-01
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High intensity gait training
One session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week
High intensity gait training
2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18
* Forward stepping practice
* Backwards stepping practices
* Sidestepping
* Stairs
* Balance and compliant surface training while walking
* Propulsion
* Lateral balance training
* Stability training
* Stance control training
* Limb advancement
Exoskeleton mediated gait training
Two sessions of High-Intensity Gait Training
Exoskeleton mediated gait training
1 session of Forward Walking with EksoGT per week
1 session of conventional neurorehabilitation intervention per week
* Transfer training
* Gait training
* Balance (sitting/standing; static/dynamic)
* Strength
* Neuromuscular re-education
* Orthotics
* Positioning
* Caregiver education
* Assistive device
* Wheelchair assessment and mobility
* Endurance training
Interventions
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Exoskeleton mediated gait training
1 session of Forward Walking with EksoGT per week
1 session of conventional neurorehabilitation intervention per week
* Transfer training
* Gait training
* Balance (sitting/standing; static/dynamic)
* Strength
* Neuromuscular re-education
* Orthotics
* Positioning
* Caregiver education
* Assistive device
* Wheelchair assessment and mobility
* Endurance training
High intensity gait training
2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18
* Forward stepping practice
* Backwards stepping practices
* Sidestepping
* Stairs
* Balance and compliant surface training while walking
* Propulsion
* Lateral balance training
* Stability training
* Stance control training
* Limb advancement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English or Spanish-speaking
* A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
* Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic
Exclusion Criteria
* \> 220 pounds (100 kg)
* Height \< 5'0" or \> 6'4"
* Unable to take a few steps with assistance
* A score of ≥ 50/56 on Berg Balance Scale (BBS)
* A score of ≥ 26/30 on Functional Gait Assessment (FGA)
* Resting blood pressure \>180/110 mmHg
* Resting heart rate \> 120 bpm
* Severe cardiac disease (New York Heart Association Classification IV)
* Severe spasticity (Modified Ashworth score \> 3)
* Unstable spine or unhealed pelvic/limb fractures
* Active heterotrophic ossification impacting lower extremity range of motion
* Significant lower or upper extremity contractures
* Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
* Pregnancy
* Colostomy
* Poor skin integrity in areas in contact with the EksoGTTM
* Unresolved deep vein thrombosis
* Lower limb prosthesis or amputation
* Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
* ROM restrictions preventing normal, reciprocal gait
* Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
* Pusher syndrome
* Cortical blindness
18 Years
ALL
No
Sponsors
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Good Shepherd Rehabilitation Network
OTHER
Alvernia University
OTHER
Responsible Party
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Soo Yeon Sun, PT, PhD
Associate professor
Principal Investigators
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Soo Yeon Sun, PhD
Role: PRINCIPAL_INVESTIGATOR
Alvernia University
Kelley Limbauan, PT, DPT, NCS
Role: PRINCIPAL_INVESTIGATOR
Good Shepherd Rehabilitation Network
Locations
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Good Shepherd Rehabilitation
Allentown, Pennsylvania, United States
Countries
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Other Identifiers
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2176775-1
Identifier Type: -
Identifier Source: org_study_id
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