Spinal Cord InjuriesNCT03714997
High Intensity Exercise in Incomplete SCI
A study testing Walking training in people with Spinal Cord Injuries, run by Indiana University at 1 site in United States.
Trial summary
The goal of this study is to identify the comparative efficacy of high-intensity walking training in individuals with chronic, motor incomplete spinal cord injury as compared to lower-intensity walking exercise. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Walking training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with motor incomplete SCI (AIS C or D) > 12 mo. duration will be recruited to participate in the study, with further criteria including anatomical lesions between C1-T10..
- Participants will be between 18 and 75 years of age (note: while participants > 50 yrs with subacute SCI have a reduced probability of functional ambulation 79, participants will already be ambulatory with only minimal or no assistance and in the chronic phase of rehabilitation, and prediction rules using age will not necessarily apply in this study).
- All participants must be able to perform walking training with passive range of motion within the limits of normal locomotor function, including: 0-30 degrees ankle plantarflexion, knee flexion from 0 to 90 degrees, hip flexion to 0-90 degrees.
Who cannot join
- Participants with body mass > 400 lbs will be excluded, which is the highest limit for use of our motorized treadmill and safety harness systems.
- Participants will be medically stable with medical clearance to participate, with absence of concurrent severe medical illness including: unhealed decubiti, existing infection, significant cardiovascular or metabolic disease which limits exercise participation, significant osteoporosis (as indicated by history of fractures following injury), active heterotrophic ossification in the lower extremities, known history of peripheral nerve injury in lower legs, history of traumatic brain injury, and history of pulmonary complications that limits exercise capacity, including significant obstructive and/or restrictive lung diseases.
- Participants who are ventilator-dependent will be excluded secondary to severely impaired respiratory capacity.
- Participants with substantial orthopedic bracing to stabilize the cervical or thoracic vertebral column are not eligible due to safety concerns with harness supported ambulation training..
- Patients will also be excluded if they are unable to tolerate 10 minutes of standing without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic); previous experience in the sub-acute population suggests that 10 minutes of standing is more than sufficient for tolerating 45 minutes of walking secondary to increased activity/muscle pump minimizing risk for orthostasis.
- Individuals who are undergoing concurrent physical therapy will be excluded from the study population to eliminate confounding effects of additional physical interventions, Other therapies, such as occupational or speech therapies, will be allowed as prescribed by their physician. Individuals will be allowed and encouraged to continue their normal exercise routines during the course of the intervention, with activity monitors measuring stepping activity in all participants
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- Women of childbearing potential will not be excluded, although women who are pregnant or who are considering becoming pregnant will be excluded due to the trunk and pelvis restraints required for use during locomotion.
- All subjects prescribed oral anti-spastic medications will not be excluded, although patients with intrathecal baclofen pumps or history of recent (< 3 months) botulinum toxin injection in the lower extremities will be excluded due to potential increases in weakness interfering with the effects of stepping training performance.
- Patients with a known history of autonomic dysreflexia will not be excluded, although specific signs and symptoms of all patients with history of injury > T6 anatomical level will be closely monitored throughout training.
- Other criteria
- Men and women will be recruited for participation in the proposed clinical trial at rates consistent with national and local average of gender disparities of SCI (80% male, 20% women). Women of childbearing potential will not be excluded, although women who are pregnant or who are considering becoming pregnant will be excluded due to the trunk and pelvis restraints required for use during locomotion.
- Individuals of different ethnicities will be recruited at rates similar to the national and local ethnicity rates. Current data since 2005 indicate that of the entire population of SCI, 66.1% are Caucasian, 27.1% are African American, 6.6% are of Hispanic origin, and 2.0% Asian. These populations closely resemble those at RHI and in our previous studies in human SCI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254-2607
About this study
Official title: Mechanisms and Efficacy of High-intensity Training in Motor Incomplete Spinal Cord Injury
The goal of this study is to identify the comparative efficacy of high-intensity walking training in individuals with chronic, motor incomplete spinal cord injury as compared to lower-intensity walking exercise.
Read the detailed description
Background/Readiness: The objective of this proposal is to maximize locomotor outcomes of patients following incomplete spinal cord injury (iSCI) through identification of rehabilitation strategies that maximize recovery. Specific training parameters, such as provision of large amounts of stepping, appears to facilitate locomotor function in patients with iSCI, although other factors may be critical. In this proposed phase II randomized clinical trial, the overarching hypothesis is that the "intensity" of locomotor practice, defined as power output and estimated using cardiopulmonary measures, is critical to maximizing walking outcomes. Performance of high intensity locomotor training increases the cardiovascular and neuromuscular demands, which results in physiological changes that facilitate greater locomotor performance in individuals with and without neurological injury. There are, however, limited data supporting its utility in patients with iSCI. Recent findings suggest a role for high-intensity stepping training in variable contexts, with gains in peak locomotor capacity as compared low-intensity variable training. Additional changes in cardiopulmonary function and neuromuscular coordination provide a mechanistic rationale for the utility of this strategy. Such changes are likely due to increased central (volitional) activation, and are in sharp contrast to the long-standing notion that high intensity training impairs motor function in neurological injury.
Despite these data, genotypic variations suggest specific caveats related to high intensity training. For example, many patients possess a single nucleotide polymorphism (SNP) variation in the brain derived neurotrophic factor (BDNF) gene that may impact the activity-dependent BDNF expression thought to contribute to neuroplasticity underlying improved performance. This single nucleotide polymorphism (SNP) can influential declarative memory, with recent data suggesting a potential impact on motor recovery after neurologic injury. Previous studies indicate limited BDNF increases in patients with this SNP during high intensity exercise, although the effects of locomotor recovery with repeated high-intensity training is unclear Hypothesis/Specific Aims: The primary hypotheses are that high intensity variable stepping can markedly improve locomotor performance as well as neuromuscular and cardiopulmonary function as compared to lower-intensity training in patients with chronic motor iSCI. It is believed that genotypic variations in the ability to synthesis activity dependent BDNF may modify the effects of high intensity training. Specific Aim 1: Test if high intensity stepping training in variable contexts results in greater locomotor gains as compared to lower intensity interventions. Specific Aim 2: Test the effects of these training strategies on neuromuscular and cardiopulmonary impairments. Specific Aim 3: Test the effects of the presence of the BDNF SNP on locomotor improvements in patients following high-intensity activities Study Design: This phase II, stratified, assessor- blinded randomized clinical trial will assess the effects 2 months (up to 30 sessions) of high- vs low-intensity variable stepping training on ambulatory patients with chronic (> 1year) motor iSCI. Participants referred from outpatient therapy settings will undergo evaluation of locomotor performance, cardiopulmonary capacity, and neuromuscular coordination and impairments prior to and following each training paradigm, with 2-month follow-up assessments.
Clinical Impact: The application of high-intensity locomotor training in the clinical rehabilitation of patients with iSCI is extremely limited, despite data regarding the potential benefits in neurological intact individuals and patients with stroke. The clinical application of high-intensity training represents a simple, readily modified training parameter that can be readily implemented, and is in stark contrast to current clinical practice and challenge traditional dogma in rehabilitation medicine.
- Conditions
- Spinal Cord Injuries
- Being tested
- Walking training
- 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.
Walking trainingProcedure or surgery
Also called Locomotor training, Walking Exercise, Gait Training
Practice of walking training in variable contexts, including multiple tasks and environments specific to the patients' deficits and community walking goals.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Locomotor Training | Experimental | High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates close to 80% of heart rate reserve. Receives: Procedure: Walking training |
| Low Intensity Locomotor Training | Active comparator | High Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates from 30% to 40% of heart rate reserve. Receives: Procedure: Walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fastest overground walking speed
fastest walking speed during 10 m walk test
Measured: Changes from baseline to post-testing at 8 weeks
peak treadmill speed
fastest treadmill speed reached for 1 full minute on graded exercise test
Measured: Changes from baseline to post-testing at 8 weeks
Secondary outcomes (2)
6 min walk test
distance walked over 6 min
Measured: Changes from baseline to post-testing at 8 weeks
self-selected speed
self-selected speed during 10 m walk test
Measured: Changes from baseline to post-testing at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Jul 2019
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Model description
- Parallel design randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana, United States Department of Defense
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- Thomas G Hornby, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714997
- Sponsor's protocol ID
- 1806265450
- Other IDs
- CDMRP-eBRAP-SCI170299
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2018
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hornby TG, Plawecki A, Lotter J, Shoger L, Voigtmann C, Heffron L, Lucas E, Parrott D, Henderson CE. Higher Intensity Walking Training in Individuals With Chronic Motor Incomplete Spinal Cord Injury: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2026 Jan;40(1):49-60. doi: 10.1177/15459683251399158. Epub 2025 Dec 27.
PubMed 41454653
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Efficacy of High-intensity Training in Motor Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03714997
- Acronym / sponsor ID
- 1806265450
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of Indiana, United States Department of Defense
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 22 Oct 2018 (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 goal of this study is to identify the comparative efficacy of high-intensity walking training in individuals with chronic, motor incomplete spinal cord injury as compared to lower-intensity walking exercise.
Detailed description
Background/Readiness: The objective of this proposal is to maximize locomotor outcomes of patients following incomplete spinal cord injury (iSCI) through identification of rehabilitation strategies that maximize recovery. Specific training parameters, such as provision of large amounts of stepping, appears to facilitate locomotor function in patients with iSCI, although other factors may be critical. In this proposed phase II randomized clinical trial, the overarching hypothesis is that the "intensity" of locomotor practice, defined as power output and estimated using cardiopulmonary measures, is critical to maximizing walking outcomes. Performance of high intensity locomotor training increases the cardiovascular and neuromuscular demands, which results in physiological changes that facilitate greater locomotor performance in individuals with and without neurological injury. There are, however, limited data supporting its utility in patients with iSCI. Recent findings suggest a role for high-intensity stepping training in variable contexts, with gains in peak locomotor capacity as compared low-intensity variable training. Additional changes in cardiopulmonary function and neuromuscular coordination provide a mechanistic rationale for the utility of this strategy. Such changes are likely due to increased central (volitional) activation, and are in sharp contrast to the long-standing notion that high intensity training impairs motor function in neurological injury.
Despite these data, genotypic variations suggest specific caveats related to high intensity training. For example, many patients possess a single nucleotide polymorphism (SNP) variation in the brain derived neurotrophic factor (BDNF) gene that may impact the activity-dependent BDNF expression thought to contribute to neuroplasticity underlying improved performance. This single nucleotide polymorphism (SNP) can influential declarative memory, with recent data suggesting a potential impact on motor recovery after neurologic injury. Previous studies indicate limited BDNF increases in patients with this SNP during high intensity exercise, although the effects of locomotor recovery with repeated high-intensity training is unclear Hypothesis/Specific Aims: The primary hypotheses are that high intensity variable stepping can markedly improve locomotor performance as well as neuromuscular and cardiopulmonary function as compared to lower-intensity training in patients with chronic motor iSCI. It is believed that genotypic variations in the ability to synthesis activity dependent BDNF may modify the effects of high intensity training. Specific Aim 1: Test if high intensity stepping training in variable contexts results in greater locomotor gains as compared to lower intensity interventions. Specific Aim 2: Test the effects of these training strategies on neuromuscular and cardiopulmonary impairments. Specific Aim 3: Test the effects of the presence of the BDNF SNP on locomotor improvements in patients following high-intensity activities Study Design: This phase II, stratified, assessor- blinded randomized clinical trial will assess the effects 2 months (up to 30 sessions) of high- vs low-intensity variable stepping training on ambulatory patients with chronic (> 1year) motor iSCI. Participants referred from outpatient therapy settings will undergo evaluation of locomotor performance, cardiopulmonary capacity, and neuromuscular coordination and impairments prior to and following each training paradigm, with 2-month follow-up assessments.
Clinical Impact: The application of high-intensity locomotor training in the clinical rehabilitation of patients with iSCI is extremely limited, despite data regarding the potential benefits in neurological intact individuals and patients with stroke. The clinical application of high-intensity training represents a simple, readily modified training parameter that can be readily implemented, and is in stark contrast to current clinical practice and challenge traditional dogma in rehabilitation medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel design randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High Intensity Locomotor Training | Experimental | Procedure: Walking trainingHigh Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates close to 80% of heart rate reserve. |
| Low Intensity Locomotor Training | Active comparator | Procedure: Walking trainingHigh Intensity Locomotor Training will consist of 30 sessions of walking related activities in variable contexts (i..e, on a treadmill, overground, and on stairs), with a primary goal to achieve 40 minutes of walking within 1 hour sessions while achieving heart rates from 30% to 40% of heart rate reserve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with motor incomplete SCI (AIS C or D) > 12 mo. duration will be recruited to participate in the study, with further criteria including anatomical lesions between C1-T10..
- Participants will be between 18 and 75 years of age (note: while participants > 50 yrs with subacute SCI have a reduced probability of functional ambulation 79, participants will already be ambulatory with only minimal or no assistance and in the chronic phase of rehabilitation, and prediction rules using age will not necessarily apply in this study).
- All participants must be able to perform walking training with passive range of motion within the limits of normal locomotor function, including: 0-30 degrees ankle plantarflexion, knee flexion from 0 to 90 degrees, hip flexion to 0-90 degrees.
Key exclusion criteria (12 listed)
- Participants with body mass > 400 lbs will be excluded, which is the highest limit for use of our motorized treadmill and safety harness systems.
- Participants will be medically stable with medical clearance to participate, with absence of concurrent severe medical illness including: unhealed decubiti, existing infection, significant cardiovascular or metabolic disease which limits exercise participation, significant osteoporosis (as indicated by history of fractures following injury), active heterotrophic ossification in the lower extremities, known history of peripheral nerve injury in lower legs, history of traumatic brain injury, and history of pulmonary complications that limits exercise capacity, including significant obstructive and/or restrictive lung diseases.
- Participants who are ventilator-dependent will be excluded secondary to severely impaired respiratory capacity.
- Participants with substantial orthopedic bracing to stabilize the cervical or thoracic vertebral column are not eligible due to safety concerns with harness supported ambulation training..
- Patients will also be excluded if they are unable to tolerate 10 minutes of standing without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic); previous experience in the sub-acute population suggests that 10 minutes of standing is more than sufficient for tolerating 45 minutes of walking secondary to increased activity/muscle pump minimizing risk for orthostasis.
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 |
|---|---|---|
| Walking trainingAlso: Locomotor training, Walking Exercise, Gait TrainingPractice of walking training in variable contexts, including multiple tasks and environments specific to the patients' deficits and community walking goals. | Procedure or surgery | High Intensity Locomotor Training, Low Intensity Locomotor Training |
Primary outcome
Fastest overground walking speed
Time frame: Changes from baseline to post-testing at 8 weeks
fastest walking speed during 10 m walk test
peak treadmill speed
Time frame: Changes from baseline to post-testing at 8 weeks
fastest treadmill speed reached for 1 full minute on graded exercise test
2 secondary outcomes
6 min walk test
Time frame: Changes from baseline to post-testing at 8 weeks
self-selected speed
Time frame: Changes from baseline to post-testing at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 41454653Hornby TG, Plawecki A, Lotter J, Shoger L, Voigtmann C, Heffron L, Lucas E, Parrott D, Henderson CE. Higher Intensity Walking Training in Individuals With Chronic Motor Incomplete Spinal Cord Injury: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2026 Jan;40(1):49-60. doi: 10.1177/15459683251399158. Epub 2025 Dec 27.
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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. This study is not recruiting at the moment.
Thomas G Hornby principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking training in people with Spinal Cord Injuries, run by Indiana University at 1 site in United States.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fastest overground walking speed (time frame: Changes from baseline to post-testing at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714997, which also lists 1 linked publication.
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 16 Jan 2026.