Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury
NCT ID: NCT05218447
Last Updated: 2025-02-06
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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RECRUITING
NA
144 participants
INTERVENTIONAL
2022-05-20
2025-09-14
Brief Summary
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Detailed Description
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Aim 1: Using a randomized controlled trial, prospectively examine whether the dosing frequency \[24 sessions delivered as high, moderate, or low frequency, defined by number days/week (4, 3, or 2 days/week over 6, 8, 12 weeks)\] of RGT therapy provided during the acute/subacute recovery phase after motor incomplete SCI impacts outcomes compared to usual care only.
Aim 2: Investigate the difference over 9 months of the neuroplastic effect of RGT dosing as measured by single pulse TMS.
Aim 3: Evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low Frequency
Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks
Robotic Gait Training
Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.
Moderate Frequency
Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks
Robotic Gait Training
Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.
High Frequency
Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks
Robotic Gait Training
Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.
Control Group
Subjects will receive usual care gait training without robotic gait training
Usual Care (UC) Gait Training
Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.
Interventions
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Robotic Gait Training
Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.
Usual Care (UC) Gait Training
Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting.
Subjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute/Subacute phase of recovery
* Medically stable as deemed by physician
* Undergoing medical care and rehabilitation at Baylor Scott \& White Institute for Rehabilitation
* Both genders and all races and ethnicities
* Meet the Ekso robotic exoskeleton frame limitations
* Continence of or a program for bladder and bowel management
Exclusion Criteria
* Degenerative diagnoses
* Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment
* Pregnancy
16 Years
85 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Texas Woman's University
UNKNOWN
Baylor Research Institute
OTHER
Responsible Party
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Chad Swank
Research Investigator
Principal Investigators
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Chad Swank, PhD, PT, NCS
Role: PRINCIPAL_INVESTIGATOR
Baylor Research Institute
Locations
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Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Baylor Scott & White Institute for Rehabilitation
Role: primary
References
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Swank C, Trammell M, Bennett M, Ochoa C, Callender L, Sikka S, Driver S. The utilization of an overground robotic exoskeleton for gait training during inpatient rehabilitation-single-center retrospective findings. Int J Rehabil Res. 2020 Sep;43(3):206-213. doi: 10.1097/MRR.0000000000000409.
Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
DiPasquale J, Trammell M, Clark K, Fowler H, Callender L, Bennett M, Swank C. Intensity of usual care physical therapy during inpatient rehabilitation for people with neurologic diagnoses. PM R. 2022 Jan;14(1):46-57. doi: 10.1002/pmrj.12577. Epub 2021 Apr 15.
Swank C, Galvan C, DiPasquale J, Callender L, Sikka S, & Driver D. Lessons Learned with Robotic Exoskeleton Use During Rehabilitation - therapeutic and medical severity considerations. Technology & Disability. 2020; 32(2): 103-110.
Suhalka A, da Silva Areas FZ, Meza F, Ochoa C, Driver S, Sikka S, Hamilton R, Goh HT, Callender L, Bennett M, Shih HT, Swank C. Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol. Trials. 2024 Oct 18;25(1):690. doi: 10.1186/s13063-024-08503-0.
Other Identifiers
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BSWRI IRB 021-205
Identifier Type: -
Identifier Source: org_study_id
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