Spinal Cord InjuriesNCT05337982
Eccentric Muscle Training, Stimulation, and Biomarkers in SCI
A study testing Downhill Eccentric Treadmill Training with Electrical Stimulation in people with Spinal Cord Injuries and Healthy, run by Ohio State University at 2 sites in 2 countries.
Trial summary
The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Healthy
- What is being tested?
- Downhill Eccentric Treadmill Training with Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 May 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY:
- Discharged from inpatient rehabilitation;
- AIS A-D at neurologic level C1-T10;
- 18-85 years old.
- Healthy controls:
- Adults 18-85 years old;
- no recent major musculoskeletal injury;
- no recent surgery.
Who cannot join
- SCI participants:
- Use of botox in the past 3 months that reduces skeletal muscle function;
- other neurologic conditions (i.e. brain injury, stroke, HIV);
- current cancer diagnosis;
- active deep vein thrombosis and anti-coagulation therapy;
- skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training.
Show all 20Show fewer
- pregnancy;
- ventilator-dependence;
- cognitive conditions that preclude providing informed consent.
- Implanted medical devices that are contraindicated for electrical stimulation or MRI *(If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)
- Healthy controls:
- Implanted medical devices that are contraindicated for MRI (MRI participants only);
- neurologic conditions (i.e. brain injury, stroke, HIV);
- current cancer diagnosis;
- clotting disorders requiring anti-coagulation therapy;
- inflammatory conditions like arthritis, ulcerative colitis, lupus, etc;
- pregnancy;
- fear of needles;
- claustrophobia;
- cognitive conditions that preclude providing informed consent.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Michele Basso, EdD, PT, 614-814-1404, michele.basso@osumc.edu
Michele Basso, EdD
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver
Lara Boyd, lara.boyd@ubc.ca
About this study
Official title: Eccentric Motor Training With Neuromodulation and Biomarkers for Rehabilitation Readiness in Subacute SCI
The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program will be in addition to any other rehabilitation therapy and will not replace standard rehabilitation. The hope is to see if downhill training with muscle stimulation, when delivered at the most ideal time, will improve trunk and leg movement, walking, and overall function. This recovery of movement and function will be compared to people with SCI receiving standard rehabilitation alone. Certain regions of the brain and spinal cord will also be studied using MRI scans to determine if these are affected by the training and compare to individuals without SCI. The total length of the study for SCI participants will be up to 16 weeks if in the standard of care group and up to 33 weeks if in the trained group. Healthy control participants will be involved for 1-2 visits.
Read the detailed description
SCI group: Individuals 3 months (+/-2 months) after SCI will be randomized into standard of care control group or augmented rehabilitation group (DownHill training with STIMulation = dhSTIM group). The study statistician will produce the randomization schedule with varying permuted blocks of size 3 and 6. The randomization schedule will be uploaded to REDCap for randomization of subjects at the time of enrollment into the study. The dhSTIM group will have cerebrospinal fluid (CSF) and blood collected and analyzed. These will be collected for research purposes only by the study's experienced proceduralist unless it is being collected clinically within the required timeframe for the study. CSF is collected via lumbar puncture under guided fluoroscopy which is a standardized technique to collect CSF and minimizes risks. If not enough CSF is collected on the first attempt, a second attempt may be required which is not expected due to the use of guided fluoroscopy but may occur in standard practice. Based on inflammatory status relative to healthy controls, the dhSTIM group will be directed to a Go group - immediate start at ~3 months) or No Go Group - delayed start at ~6 months. All SCI groups (dhSTIM Go, dhSTIM No Go, SOC) will also continue with regular outpatient therapy. The augmented rehabilitation groups and healthy controls will undergo MRI. The dhSTIM training will be a 12-week downhill training program combined with Xcite electrical stimulation 3 times a week. Participants will walk downhill on a treadmill with a harness for body weight support and trainers assisting as needed. All SCI groups (dhSTIM Go, dhSTIM No Go, SOC) will participate in pre, post, and 4 week follow-up assessments as follows: Biomechanical analysis will include kinematics, kinetics, and electromyography (EMG) while on the treadmill. Clinical outcome measures will include: American Spinal Injury Association (ASIA) Impairment scale (AIS), International standards for neurological classification of spinal cord injury (ISNCSCI), Autonomic Standards Assessment Form, Neuromuscular Recovery Scale, Neuropathic Pain Symptom Inventory, Pain Numeric Rating Scale, Spinal Cord Injury Independence Measure (SCIM3), 6 minute walk test (MWT), 10 meter walk test (MWT). Clinical outcome measures conducted as standard measures will be collected will be accessed via medical record when available. If absent from the medical record, they will be collected by a rater blind to group assignment. Leg strength will also be measured using the Biodex system. An additional MRI scan will be obtained at the end of the 12 week training period for the dhSTIM GO and dhSTIM No Go groups. Healthy Control Group: Healthy participants from the community will volunteer for the CSF and blood collection by the study's experienced proceduralist. CSF will be collected from at least half of the healthy controls prior to enrolling participants with SCI to provide a sample of normal levels of inflammatory genes and concentration of microglia-like cells as a baseline. CSF is collected for research purposes only via lumbar puncture under guided fluoroscopy which is a standardized technique to collect CSF and minimizes risks. If not enough CSF is collected on the first attempt, a second attempt may be required which is not expected due to the use of guided fluoroscopy but may occur in standard practice. When possible, they will also participate in one MRI scan of the brain and spinal cord. Due to MRI restrictions, some healthy controls may only be able to participate in biomarkers collection, some to only participate in MRI scans and some to participate in both types of collection. Individuals for the healthy control group will be enrolled until a total of n=10 +1 for biomarkers and n=10+1 for MRI is reached. One additional individual is allocated to account for dropouts. If there no individuals are able to take part in both MRI and fluid biomarker collection, then up to n=22 healthy controls will be enrolled.
- Conditions
- Spinal Cord Injuries, Healthy
- Being tested
- Downhill Eccentric Treadmill Training with Electrical Stimulation
- Keywords
- Spinal Cord Injury, SCI, Biomarkers, MRI, Locomotor Training, Downhill, Neuromodulation, Electrical Stimulation, CSF, Rehabilitation, Physical Therapy, Eccentric, Treadmill, blood draw
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Downhill Eccentric Treadmill Training with Electrical StimulationOther
Participants will walk on a treadmill with a downward incline with support from a harness and assistance from trainers as needed. Participants will also simultaneously receive stimulation to their muscles including their trunk and legs. Each session will include 20 minutes of walking divided into 5 minute bouts with 5 minute rest breaks in between for 3 sessions per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SCI Go | Experimental | Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately. Receives: Other: Downhill Eccentric Treadmill Training with Electrical Stimulation |
| SCI No Go | Experimental | Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months. Receives: Other: Downhill Eccentric Treadmill Training with Electrical Stimulation |
| SCI SOC | No intervention | Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy. |
| Healthy Control | No intervention | Healthy controls will provide biomarker and/or myelin (MRI) data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in electromyography of eccentric acting muscles
Muscle activation during weight acceptance while walking on a treadmill
Measured: 12 weeks
Change from baseline in kinetics during weight acceptance
Peak magnitude of loading response as measured by the peak magnitude of power absorption during the weight acceptance phase of walking on a treadmill
Measured: 12 weeks
Change from baseline in kinematics during weight acceptance: hip range of motion
Range of motion of the hip joint during walking on a treadmill
Measured: 12 weeks
Change from baseline in kinematics during weight acceptance: knee range of motion
Range of motion of the knee joint during walking on a treadmill
Measured: 12 weeks
Change from baseline in kinematics during weight acceptance: ankle range of motion
Range of motion of the ankle joint during walking on a treadmill
Measured: 12 weeks
Change from baseline in kinematics during weight acceptance: hip acceleration
Acceleration of the hip joint during walking on a treadmill
Measured: 12 weeks
Change from baseline in kinematics during weight acceptance: knee acceleration
Acceleration of the knee joint during walking on a treadmill
Measured: 12 weeks
Change from baseline in kinematics during weight acceptance: ankle acceleration
Acceleration of the ankle joint during walking on a treadmill
Measured: 12 weeks
Change from baseline in myelination in brain and spinal cord measured by Magnetic Resonance Imaging (MRI)
Myelin spared pre and post intervention in the motor areas of the brain and cervical spinal cord compared to healthy controls
Measured: 12 weeks
Secondary outcomes (32)
Change from baseline in ASIA Impairment Scale (AIS)
Classification of injury using grades A, B, C, D or E indicating level of impairment including complete (A), sensory incomplete (B), or motor incomplete (C and D). A classification differences between C and D indicates if less or more than half (respectively) of myotomes below the level of injury are able to at least move through the full range of motion against gravity. A grade of E indicates normal sensory and strength function.
Measured: 12 weeks
Change from 12 weeks to 16 weeks in American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Classification of injury using grades A, B, C, D or E indicating level of impairment including complete (A), sensory incomplete (B), or motor incomplete (C and D). A classification differences between C and D indicates if less or more than half (respectively) of myotomes below the level of injury are able to at least move through the full range of motion against gravity. A grade of E indicates normal sensory and strength function.
Measured: 16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Motor scores range from 0-50 for each the right and left sides and 50 for each the upper extremities and lower extremities. A higher score indicates better outcomes (strength).
Measured: 12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Motor scores range from 0-50 for each the right and left sides and 50 for each the upper extremities and lower extremities. A higher score indicates better outcomes (strength).
Measured: 16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Sensory scores range from 0-112 for each the right and left sides. A higher score indicates better outcomes (sensation).
Measured: 12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Sensory scores range from 0-112 for each the right and left sides. A higher score indicates better outcomes (sensation).
Measured: 16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. NLI can range from the first level of the cervical spinal cord (C1) indicating tetraplegia (C1-thoracic, T1) to the final sacral level (S4-5) which would indicate paraplegia.
Measured: 12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. NLI can range from the first level of the cervical spinal cord (C1) indicating tetraplegia (C1-thoracic, T1) to the final sacral level (S4-5) which would indicate paraplegia.
Measured: 16 weeks
Change from baseline on Autonomic Standards Assessment Form
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI). Patient self-reported responses include normal (2) when there is no change in neurological control with respect to a specific function; reduced or altered (1) neurological control with regard to a specific function; absent (0) neurological control with regard to a specific function; and unable to assess a specific function (not testable, NT).
Measured: 12 weeks
Change from 12 weeks to 16 weeks on Autonomic Standards Assessment Form
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI). Patient self-reported responses include normal (2) when there is no change in neurological control with respect to a specific function; reduced or altered (1) neurological control with regard to a specific function; absent (0) neurological control with regard to a specific function; and unable to assess a specific function (not testable, NT).
Measured: 16 weeks
Change from baseline on Neuromuscular Recovery Scale (NRS) score
Measures quality of movement without compensation. Scored in phases 1-4 with subphases A-C, with scores indicating most impairment (1A, numeric value of 1-1.99) to least impairment (4C, numeric value of 12).
Measured: 12 weeks
Change from 12 weeks to 16 weeks on Neuromuscular Recovery Scale (NRS) score
Measures quality of movement without compensation. Scored in phases 1-4 with subphases A-C, with scores indicating most impairment (1A, numeric value of 1) to least impairment (4C, numeric value of 12).
Measured: 16 weeks
Change from baseline in 6 Minute Walk Test (6MWT)
The distance walked overground within 6 minutes (meters).
Measured: 12 weeks
Change from 12 weeks to 16 weeks in 6 Minute Walk Test (6MWT)
The distance walked overground within 6 minutes (meters).
Measured: 16 weeks
Change from baseline in 10 Meter Walk Test
Gait speed - the time it takes to walk 10 meters (seconds)
Measured: 12 weeks
Change from 12 weeks to 16 weeks in 10 Meter Walk Test
Gait speed - the time it takes to walk 10 meters (seconds)
Measured: 16 weeks
Change from baseline in Spinal Cord Independence Measure III (SCIM3) score
Assessment of various activities of daily living. Scoring ranges per category: Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) with higher scores indicating more independence.
Measured: 12 weeks
Change from 12 weeks to 16 weeks in Spinal Cord Independence Measure III (SCIM3) score
Assessment of various activities of daily living. Scoring ranges per category: Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) with higher scores indicating more independence.
Measured: 16 weeks
Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) scale
Characterization of neuropathic pain symptom severity in 5 subscales (burning, pressing, paroxysmal, evoked, and paresthesia/dysesthesia. Each item is scored on a scale of 0 (indicating no pain) to 10 (worst pain imaginable). Each subscale is added then divided by 100, giving a total score ranging from 0-1 with scores closest to 1 indicating worse pain.
Measured: 12 weeks
Change from 12 weeks to 16 weeks in Neuropathic Pain Symptom Inventory (NPSI) scale
Characterization of neuropathic pain symptom severity in 5 subscales (burning, pressing, paroxysmal, evoked, and paresthesia/dysesthesia. Each item is scored on a scale of 0 (indicating no pain) to 10 (worst pain imaginable). Each subscale is added then divided by 100, giving a total score ranging from 0-1 with scores closest to 1 indicating worse pain.
Measured: 16 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Subjective measure of the intensity of pain on a scale if 0-10, with a higher score indicating worse pain.
Measured: 12 weeks
Change from 12 weeks to 16 weeks in Numeric Pain Rating Scale (NPRS)
Subjective measure of the intensity of pain on a scale if 0-10, with a higher score indicating worse pain.
Measured: 16 weeks
Change from baseline in Strength Testing
Maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect) measured by a Biodex.
Measured: 12 weeks
Change from 12 weeks to 16 weeks in Strength Testing
Maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect) measured by a Biodex.
Measured: 16 weeks
Change from baseline in electromyography of eccentric acting muscles at 12 weeks
Muscle activation during weight acceptance while walking on a treadmill
Measured: 12 weeks
Change from 12 weeks to 16 weeks in kinetics during weight acceptance
Peak magnitude of loading response as measured by the peak magnitude of power absorption during the weight acceptance phase of walking on a treadmill
Measured: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip range of motion
Range of motion of the hip joint during walking on a treadmill
Measured: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee range of motion
Range of motion of the knee joint during walking on a treadmill
Measured: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle range of motion
Range of motion of the ankle joint during walking on a treadmill
Measured: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip acceleration
Acceleration of the hip joint during walking on a treadmill
Measured: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee acceleration
Acceleration of the knee joint during walking on a treadmill
Measured: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle acceleration
Acceleration of the ankle joint during walking on a treadmill
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start17 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Notre Dame, University of British Columbia, United States Department of Defense
- Responsible party
- Principal investigator, Michele Basso, Ohio State University
- Investigators
- D. Michele Basso, EdD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337982
- Sponsor's protocol ID
- 2021H0209
- Other IDs
- GRANT13192544
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Motor Training With Neuromodulation and Biomarkers for Rehabilitation Readiness in Subacute SCI
- ClinicalTrials.gov ID
- NCT05337982
- Acronym / sponsor ID
- 2021H0209
- Conditions
- Spinal Cord Injuries, Healthy
- Keywords
- Spinal Cord Injury, SCI, Biomarkers, MRI, Locomotor Training, Downhill, Neuromodulation, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Notre Dame, University of British Columbia, United States Department of Defense
- Study start
- 17 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program will be in addition to any other rehabilitation therapy and will not replace standard rehabilitation. The hope is to see if downhill training with muscle stimulation, when delivered at the most ideal time, will improve trunk and leg movement, walking, and overall function. This recovery of movement and function will be compared to people with SCI receiving standard rehabilitation alone. Certain regions of the brain and spinal cord will also be studied using MRI scans to determine if these are affected by the training and compare to individuals without SCI. The total length of the study for SCI participants will be up to 16 weeks if in the standard of care group and up to 33 weeks if in the trained group. Healthy control participants will be involved for 1-2 visits.
Detailed description
SCI group: Individuals 3 months (+/-2 months) after SCI will be randomized into standard of care control group or augmented rehabilitation group (DownHill training with STIMulation = dhSTIM group). The study statistician will produce the randomization schedule with varying permuted blocks of size 3 and 6. The randomization schedule will be uploaded to REDCap for randomization of subjects at the time of enrollment into the study. The dhSTIM group will have cerebrospinal fluid (CSF) and blood collected and analyzed. These will be collected for research purposes only by the study's experienced proceduralist unless it is being collected clinically within the required timeframe for the study. CSF is collected via lumbar puncture under guided fluoroscopy which is a standardized technique to collect CSF and minimizes risks. If not enough CSF is collected on the first attempt, a second attempt may be required which is not expected due to the use of guided fluoroscopy but may occur in standard practice. Based on inflammatory status relative to healthy controls, the dhSTIM group will be directed to a Go group - immediate start at ~3 months) or No Go Group - delayed start at ~6 months. All SCI groups (dhSTIM Go, dhSTIM No Go, SOC) will also continue with regular outpatient therapy. The augmented rehabilitation groups and healthy controls will undergo MRI. The dhSTIM training will be a 12-week downhill training program combined with Xcite electrical stimulation 3 times a week. Participants will walk downhill on a treadmill with a harness for body weight support and trainers assisting as needed. All SCI groups (dhSTIM Go, dhSTIM No Go, SOC) will participate in pre, post, and 4 week follow-up assessments as follows: Biomechanical analysis will include kinematics, kinetics, and electromyography (EMG) while on the treadmill. Clinical outcome measures will include: American Spinal Injury Association (ASIA) Impairment scale (AIS), International standards for neurological classification of spinal cord injury (ISNCSCI), Autonomic Standards Assessment Form, Neuromuscular Recovery Scale, Neuropathic Pain Symptom Inventory, Pain Numeric Rating Scale, Spinal Cord Injury Independence Measure (SCIM3), 6 minute walk test (MWT), 10 meter walk test (MWT). Clinical outcome measures conducted as standard measures will be collected will be accessed via medical record when available. If absent from the medical record, they will be collected by a rater blind to group assignment. Leg strength will also be measured using the Biodex system. An additional MRI scan will be obtained at the end of the 12 week training period for the dhSTIM GO and dhSTIM No Go groups. Healthy Control Group: Healthy participants from the community will volunteer for the CSF and blood collection by the study's experienced proceduralist. CSF will be collected from at least half of the healthy controls prior to enrolling participants with SCI to provide a sample of normal levels of inflammatory genes and concentration of microglia-like cells as a baseline. CSF is collected for research purposes only via lumbar puncture under guided fluoroscopy which is a standardized technique to collect CSF and minimizes risks. If not enough CSF is collected on the first attempt, a second attempt may be required which is not expected due to the use of guided fluoroscopy but may occur in standard practice. When possible, they will also participate in one MRI scan of the brain and spinal cord. Due to MRI restrictions, some healthy controls may only be able to participate in biomarkers collection, some to only participate in MRI scans and some to participate in both types of collection. Individuals for the healthy control group will be enrolled until a total of n=10 +1 for biomarkers and n=10+1 for MRI is reached. One additional individual is allocated to account for dropouts. If there no individuals are able to take part in both MRI and fluid biomarker collection, then up to n=22 healthy controls will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCI Go | Experimental | Other: Downhill Eccentric Treadmill Training with Electrical StimulationParticipants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately. |
| SCI No Go | Experimental | Other: Downhill Eccentric Treadmill Training with Electrical StimulationParticipants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months. |
| SCI SOC | No intervention | –Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy. |
| Healthy Control | No intervention | –Healthy controls will provide biomarker and/or myelin (MRI) data |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Discharged from inpatient rehabilitation;
- AIS A-D at neurologic level C1-T10;
- 18-85 years old.
- Adults 18-85 years old;
- no recent major musculoskeletal injury;
Key exclusion criteria (20 listed)
- Use of botox in the past 3 months that reduces skeletal muscle function;
- other neurologic conditions (i.e. brain injury, stroke, HIV);
- current cancer diagnosis;
- active deep vein thrombosis and anti-coagulation therapy;
- skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Downhill Eccentric Treadmill Training with Electrical StimulationParticipants will walk on a treadmill with a downward incline with support from a harness and assistance from trainers as needed. Participants will also simultaneously receive stimulation to their muscles including their trunk and legs. Each session will include 20 minutes of walking divided into 5 minute bouts with 5 minute rest breaks in between for 3 sessions per week for 12 weeks. | Other | SCI Go, SCI No Go |
Primary outcome
Change from baseline in electromyography of eccentric acting muscles
Time frame: 12 weeks
Muscle activation during weight acceptance while walking on a treadmill
Change from baseline in kinetics during weight acceptance
Time frame: 12 weeks
Peak magnitude of loading response as measured by the peak magnitude of power absorption during the weight acceptance phase of walking on a treadmill
Change from baseline in kinematics during weight acceptance: hip range of motion
Time frame: 12 weeks
Range of motion of the hip joint during walking on a treadmill
Change from baseline in kinematics during weight acceptance: knee range of motion
Time frame: 12 weeks
Range of motion of the knee joint during walking on a treadmill
Change from baseline in kinematics during weight acceptance: ankle range of motion
Time frame: 12 weeks
Range of motion of the ankle joint during walking on a treadmill
Change from baseline in kinematics during weight acceptance: hip acceleration
Time frame: 12 weeks
Acceleration of the hip joint during walking on a treadmill
Change from baseline in kinematics during weight acceptance: knee acceleration
Time frame: 12 weeks
Acceleration of the knee joint during walking on a treadmill
Change from baseline in kinematics during weight acceptance: ankle acceleration
Time frame: 12 weeks
Acceleration of the ankle joint during walking on a treadmill
Change from baseline in myelination in brain and spinal cord measured by Magnetic Resonance Imaging (MRI)
Time frame: 12 weeks
Myelin spared pre and post intervention in the motor areas of the brain and cervical spinal cord compared to healthy controls
32 secondary outcomes
Change from baseline in ASIA Impairment Scale (AIS)
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Time frame: 16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
Time frame: 16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
Time frame: 16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
Time frame: 16 weeks
Change from baseline on Autonomic Standards Assessment Form
Time frame: 12 weeks
Change from 12 weeks to 16 weeks on Autonomic Standards Assessment Form
Time frame: 16 weeks
Change from baseline on Neuromuscular Recovery Scale (NRS) score
Time frame: 12 weeks
Change from 12 weeks to 16 weeks on Neuromuscular Recovery Scale (NRS) score
Time frame: 16 weeks
Change from baseline in 6 Minute Walk Test (6MWT)
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in 6 Minute Walk Test (6MWT)
Time frame: 16 weeks
Change from baseline in 10 Meter Walk Test
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in 10 Meter Walk Test
Time frame: 16 weeks
Change from baseline in Spinal Cord Independence Measure III (SCIM3) score
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in Spinal Cord Independence Measure III (SCIM3) score
Time frame: 16 weeks
Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) scale
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in Neuropathic Pain Symptom Inventory (NPSI) scale
Time frame: 16 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in Numeric Pain Rating Scale (NPRS)
Time frame: 16 weeks
Change from baseline in Strength Testing
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in Strength Testing
Time frame: 16 weeks
Change from baseline in electromyography of eccentric acting muscles at 12 weeks
Time frame: 12 weeks
Change from 12 weeks to 16 weeks in kinetics during weight acceptance
Time frame: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip range of motion
Time frame: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee range of motion
Time frame: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle range of motion
Time frame: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip acceleration
Time frame: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee acceleration
Time frame: 16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle acceleration
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injuries
Recruiting
Efficacy of rTMS Treatment After Spinal Cord Injury
Spinal Cord Injuries, Myelopathy
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Active, not recruitingObservational study
Recovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
D. Michele Basso, EdD principal investigator
Ohio State University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Downhill Eccentric Treadmill Training with Electrical Stimulation in people with Spinal Cord Injuries and Healthy, run by Ohio State University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Basso, EdD, PT (614-814-1404, michele.basso@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in electromyography of eccentric acting muscles (time frame: 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.