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
90 participants
INTERVENTIONAL
2018-08-17
2022-12-31
Brief Summary
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Detailed Description
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* To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke
* To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke
* To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke
* To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke
* To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneousnon-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Noninvasive Spinal Stimulation with Gait Training
May receive 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.
Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.
Conventional Gait Training
May receive up to 50 min of locomotion training without 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.
Conventional gait training
May receive up to 50 min of locomotion training without 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.
Healthy Control Group
Participant in the Healthy Control Group will participate in up to 3 assessment sessions in order to obtain comparative data for Spinal Motor Evoked Potentials (MEPs), lower extremity MVC's, sidelying EMG data and overground EMG data
Healthy control group
Participant in the Healthy Control Group will participate in up to 3 assessment sessions in order to obtain comparative data for Spinal Motor Evoked Potentials (MEPs), lower extremity MVC's, sidelying EMG data and overground EMG data
Interventions
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Noninvasive spinal stimulation with gait training
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.
Conventional gait training
May receive up to 50 min of locomotion training without 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.
Healthy control group
Participant in the Healthy Control Group will participate in up to 3 assessment sessions in order to obtain comparative data for Spinal Motor Evoked Potentials (MEPs), lower extremity MVC's, sidelying EMG data and overground EMG data
Eligibility Criteria
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Inclusion Criteria
* Able and willing to give written consent and comply with study procedures
* Participants are 18 years of age or older
* Participants are at least 4 weeks post stroke
* Participants with hemiplegia secondary to a single stroke
* Functional Ambulation Category of 2 or greater - Patient needs continuous or intermittent support of one person to help with balance and coordination.
* Participants are able to provide informed consent
* Participants are not currently receiving regular physical therapy services
Exclusion Criteria
* Pregnant or nursing
* Skin allergies or irritation; open wounds
* Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
* Individuals less than18 years of age
* Individuals less than 4 weeks post stroke
* Individuals with ataxia
* Individuals with multiple stroke history
* Currently taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Tricyclic antidepressant (TCA)
* Botox injection in lower extremity within the last 4 months
* Modified Ashworth score of 3 or greater in lower extremity
* Pregnancy or nursing
* Pacemaker or anti-spasticity implantable pumps
* Active pressure sores
* Unhealed bone fractures
* Peripheral neuropathies
* Painful musculoskeletal dysfunction due to active injuries or infections
* Severe contractures in the lower extremities
* Medical illness limiting the ability to walk
* Active urinary tract infection
* Clinically significant depression, psychiatric disorders, or ongoing drug abuse
* Metal implants in their spine TMS Specific Criteria (see Safety Screening Questionnaire for Transcranial Magnetic Stimulation)
* Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
* Implanted cardiac pacemaker
* Metal implants in the head or face
* Suffers unexplained, recurring headaches
* Had a seizure in the past unrelated to the stroke event, or has epilepsy
* Skull abnormalities or fractures
* Suffered a concussion within the last 6 month
* Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
* Pregnant
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Director Max Näder Center
Principal Investigators
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Arun Jayaraman, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Kristen Hohl
Role: backup
References
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Moon Y, Yang C, Veit NC, McKenzie KA, Kim J, Aalla S, Yingling L, Buchler K, Hunt J, Jenz S, Shin SY, Kishta A, Edgerton VR, Gerasimenko YP, Roth EJ, Lieber RL, Jayaraman A. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series. Biomed Eng Online. 2024 Apr 1;23(1):38. doi: 10.1186/s12938-024-01231-1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU00206430
Identifier Type: -
Identifier Source: org_study_id
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