Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries Spinal Cord Diseases | Device: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training Other: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training Other: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training | Not Applicable |
OBJECTIVES:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury |
Actual Study Start Date : | December 1, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
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Experimental: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
May receive up to 45 minutes of AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression. Intervention: Device: AIH prior to Noninvasive spinal stimulation during gait training |
Device: Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Subjects will receive up to 45 minutes of AIH prior to receiving transcutaneous electrical spinal cord stimulation delivered by a Transcutaneous Spinal Cord Neurostimulator while performing locomotor activities.
Other Name: AIH + tSCS+ Gait
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Sham Comparator: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
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Other: Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training
Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Other Name: SHAM AIH + tSCS + Gait
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Sham Comparator: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
May receive up to 45 minutes of Sham AIH prior to up to 50 min of locomotion training with sham transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
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Other: Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training
Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
Other Name: SHAM AIH + SHAM tSCS + Gait
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
We will not include the following populations:
Contact: Kelly A McKenzie, PT, DPT, NCS | 312-238-7111 | kmckenzie@sralab.org |
United States, Illinois | |
Shirley Ryan AbilityLab | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Kelly A McKenzie, PT, DPT, NCS | |
Principal Investigator: Arun Jayaraman, PT, PhD |
Principal Investigator: | Arun Jayaraman, PT, PhD | Shirley Ryan AbilityLab |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 17, 2019 | ||||||||
First Posted Date ICMJE | April 22, 2019 | ||||||||
Last Update Posted Date | March 17, 2021 | ||||||||
Actual Study Start Date ICMJE | December 1, 2020 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change in Gait Symmetry [ Time Frame: Session 1 (baseline test, initial visit), After 5 intervention sessions (Post Test), 1 week post (1 week follow up Post) ] Participants will ambulate along Gait Rite electronic walkway 6 times (3 times per gait speed) to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The Gait Rite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. The Gait Rite electronic walkway for the study shall be a minimum of 14 feet long. The Gait Rite data capture was chosen as measurement of the patient's overall gait quality.
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Original Primary Outcome Measures ICMJE |
Change in Gait Kinematics [ Time Frame: Session 1 (baseline test, initial visit), Session 16 (Midpoint, 4 weeks), Session 30 (Post intervention, week 8), Session 33 (3 month follow-up), Session 35 (6 month follow-up), Session 37 (12 month follow-up) ] Participants will ambulate along Gait Rite electronic walkway 6 times (3 times per gait speed) to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training | ||||||||
Official Title ICMJE | Locomotor Function Following Acute Intermittent Hypoxia (AIH) and Transcutaneous Electrical Spinal Cord Stimulation (tSCS) With Gait Therapy Versus Traditional Gait Therapy in Individuals With Spinal Cord Injury | ||||||||
Brief Summary | This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury. | ||||||||
Detailed Description |
OBJECTIVES:
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
36 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2022 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
We will not include the following populations:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03922802 | ||||||||
Other Study ID Numbers ICMJE | STU00211806 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab | ||||||||
Study Sponsor ICMJE | Shirley Ryan AbilityLab | ||||||||
Collaborators ICMJE | University of California, Los Angeles | ||||||||
Investigators ICMJE |
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PRS Account | Shirley Ryan AbilityLab | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |