Spinal Cord InjuriesNCT03144388
Task-specificity for Locomotor Recovery Following SCI
A study testing Variable Stepping Training and Variable Non-specific Training in people with Spinal Cord Injuries, run by Indiana University at 1 site in United States.
Trial summary
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). 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?
- Variable Stepping Training and Variable Non-specific Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Sep 2020
- 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 chronic (>1 yr duration) motor iSCI at the level or T10 (anatomical) or above
- ages 18-75 years
- ability to walk without physical assistance but with below-knee braces and assistive devices as needed
- self-selected gait speeds between 0.01-1.0 m/s.
- not currently receiving physical therapy
Who cannot join
- uncontrolled cardiopulmonary or metabolic disease that limits exercise participation
- active heterotopic ossification
- recurrent history of lower extremity fractures
- previous orthopedic or other peripheral or central neurological injury that may impair locomotor function
- history of botulinum toxin injection < 3 months prior
- Patients who are prescribed intrathecal or oral anti-spastics should agree to limit changes in anti-spastic use throughout the training and testing period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254-2607
About this study
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation are critical to mobility outcomes following neurological injury. Specifically, the specificity, amount and intensity of physical interventions (i.e., practice) may influence specific outcomes in the patient population treated. In ambulatory patients with iSCI, there are very few studies that have controlled for or targeted these training variables or their influence on locomotor recovery. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of task-specific practice during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting. The goal of the present study is to delineate the relative contributions of amount of task-specific training on locomotor outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the investigators anticipated non-specific (i.e., non-stepping) training activities would result in smaller improvements as compared to task-specific (stepping) training. The investigators will investigate the effects of such training on walking performance and kinematics, as well as the impairments thought to contribute to walking performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI or other acute-onset neurological disorders.
Read the detailed description
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). The investigators will do this by building on previous work directed towards identifying the essential exercise training parameters that maximize locomotor recovery. Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation, including the type (specificity) and amount of task practice, are critical to mobility outcomes following neurological injury. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of amount of task-specific practice in iSCI. Indeed, no studies have carefully controlled these training parameters during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting.
Reasons for these knowledge gaps from other rehabilitation studies to patients with iSCI or lack of clinical implementation are unclear, but may be due to adherence to traditional rehabilitation theories. One concern is that practicing only stepping tasks reduces attention towards hallmark physical impairments following iSCI, such as loss of strength or postural stability, which are considered primary determinants of decreased mobility. Only a few studies have addressed whether providing only structured stepping training can mitigate these impairments without their explicit practice, but not in the iSCI population. A related concern is that focused stepping training without significant attention towards impairments or gait quality may exaggerate altered movement strategies, which could be reinforced with repeated practice. However, there is little data to suggest "worsening" of abnormal gait patterns following high intensity training. Rather, recent findings suggest patients demonstrate more normal kinematics. If focused task specific (i.e., stepping) training is to be applied clinically, the investigators must delineate its contributions towards improving locomotor function, and their effects on underlying impairments and gait kinematics.
The central hypotheses are that stepping training in iSCI results in:1) greater locomotor gains as compared to non-specific interventions; 2) gains in selected impairments underlying gait dysfunction (i.e., strength and metabolic capacity and efficiency); and, 3) improvements in gait quality. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of specificity of rehabilitation training applied early-post-stroke. In this RCT, patients > 1 year post-iSCI will be allocated to 4-6 weeks (20 session) of high-intensity stepping training or high-intensity non-specific training. Importantly, training intensity will be held constant to account for this potential confounding factor. Blinded assessments will be performed prior to and following each training paradigm. The investigators will address 3 specific aims:
Specific Aim 1: Demonstrate that high intensity stepping training in patients with chronic iSCI produces greater locomotor gains as compared to high intensity non-specific training strategies.
Hypothesis 1: High intensity stepping training will result in greater increases in gait speeds and distances Specific Aim 2: Test the effects of these training strategies on impairments and non-locomotor mobility tasks.
Hypothesis 2: Higher intensity stepping training groups will result in greater gains in metabolic capacity and efficiency.
Specific Aim 3: Analyze the potential effects of high intensity stepping or non-specific training on gait quality.
Hypothesis 3: High intensity training will result in improved sagittal-plane gait kinematics consistent with normal locomotor function, due in part to greater locomotor speeds, as compared to non-specific training strategies.
The aims represent an innovative approach to improving long-term mobility outcomes of patients with iSCI by applying selected principles of motor learning and exercise physiology yet untested in this population. Expected outcomes will be demonstration of the efficacy of a high intensity stepping training paradigm, with further understanding of potential underlying mechanisms and movement strategies used with improved locomotor performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI
- Conditions
- Spinal Cord Injuries
- Being tested
- Variable Stepping Training, Variable Non-specific 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.
Variable Stepping TrainingProcedure or surgery
Six weeks (20 sessions) of high intensity stepping training in multiple variable environments
Variable Non-specific TrainingProcedure or surgery
Six weeks (20 sessions) of high intensity stepping training in multiple variable environments
| Study group | Role | What they receive |
|---|---|---|
| Variable Stepping Training | Experimental | High intensity stepping training in multiple environments, including overground, on a treadmill and on stairs. Receives: Procedure: Variable Stepping Training |
| Variable Non-specific Training | Active comparator | High intensity non-stepping training, including balance, strength, and cycling tasks Receives: Procedure: Variable Non-specific Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
fastest comfortable walking speed over short distances
Measured: change in walking speed from baseline testing to post-testing following 6 weeks of training
Secondary outcomes (1)
Walking Distance
distance covered over 6 minutes
Measured: change in walking speed from baseline testing to post-testing following 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Jul 2017
- Primary completion30 Jun 2019
- Study completion30 Sep 2020
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 Indiana 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
- Model description
- Parallel-group with optional crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- Thomas Hornby, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144388
- Sponsor's protocol ID
- IU1705279110
- Status last verified
- Feb 2023
- First submitted
- 3 May 2017
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available as requested
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-specificity for Locomotor Recovery Following SCI
- ClinicalTrials.gov ID
- NCT03144388
- Acronym / sponsor ID
- IU1705279110
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 8 May 2017 (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 primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation are critical to mobility outcomes following neurological injury. Specifically, the specificity, amount and intensity of physical interventions (i.e., practice) may influence specific outcomes in the patient population treated. In ambulatory patients with iSCI, there are very few studies that have controlled for or targeted these training variables or their influence on locomotor recovery. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of in iSCI. Indeed, no studies have carefully controlled the amount of task-specific practice during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting. The goal of the present study is to delineate the relative contributions of amount of task-specific training on locomotor outcomes in individuals with iSCI. Using a cross-over, randomized clinical trial design, the investigators anticipated non-specific (i.e., non-stepping) training activities would result in smaller improvements as compared to task-specific (stepping) training. The investigators will investigate the effects of such training on walking performance and kinematics, as well as the impairments thought to contribute to walking performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI or other acute-onset neurological disorders.
Detailed description
The primary goal of the proposed study is to identify the contributions of the amount of task-specific practice on locomotor (i.e., walking) recovery in patients with chronic (> 1 yr) motor incomplete spinal cord injury (iSCI). The investigators will do this by building on previous work directed towards identifying the essential exercise training parameters that maximize locomotor recovery. Consistent with principles of motor learning and exercise physiology, the investigators contend that certain training (i.e., dosage) parameters of physical rehabilitation, including the type (specificity) and amount of task practice, are critical to mobility outcomes following neurological injury. Previous work suggests these training parameters may influence locomotor recovery in patients with other neurological disorders (i.e., stroke), although few studies have attempted to delineate similar contributions of amount of task-specific practice in iSCI. Indeed, no studies have carefully controlled these training parameters during physical rehabilitation of patients with iSCI, and such interventions are rarely utilized in the clinical setting.
Reasons for these knowledge gaps from other rehabilitation studies to patients with iSCI or lack of clinical implementation are unclear, but may be due to adherence to traditional rehabilitation theories. One concern is that practicing only stepping tasks reduces attention towards hallmark physical impairments following iSCI, such as loss of strength or postural stability, which are considered primary determinants of decreased mobility. Only a few studies have addressed whether providing only structured stepping training can mitigate these impairments without their explicit practice, but not in the iSCI population. A related concern is that focused stepping training without significant attention towards impairments or gait quality may exaggerate altered movement strategies, which could be reinforced with repeated practice. However, there is little data to suggest "worsening" of abnormal gait patterns following high intensity training. Rather, recent findings suggest patients demonstrate more normal kinematics. If focused task specific (i.e., stepping) training is to be applied clinically, the investigators must delineate its contributions towards improving locomotor function, and their effects on underlying impairments and gait kinematics.
The central hypotheses are that stepping training in iSCI results in:1) greater locomotor gains as compared to non-specific interventions; 2) gains in selected impairments underlying gait dysfunction (i.e., strength and metabolic capacity and efficiency); and, 3) improvements in gait quality. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of specificity of rehabilitation training applied early-post-stroke. In this RCT, patients > 1 year post-iSCI will be allocated to 4-6 weeks (20 session) of high-intensity stepping training or high-intensity non-specific training. Importantly, training intensity will be held constant to account for this potential confounding factor. Blinded assessments will be performed prior to and following each training paradigm. The investigators will address 3 specific aims:
Specific Aim 1: Demonstrate that high intensity stepping training in patients with chronic iSCI produces greater locomotor gains as compared to high intensity non-specific training strategies.
Hypothesis 1: High intensity stepping training will result in greater increases in gait speeds and distances Specific Aim 2: Test the effects of these training strategies on impairments and non-locomotor mobility tasks.
Hypothesis 2: Higher intensity stepping training groups will result in greater gains in metabolic capacity and efficiency.
Specific Aim 3: Analyze the potential effects of high intensity stepping or non-specific training on gait quality.
Hypothesis 3: High intensity training will result in improved sagittal-plane gait kinematics consistent with normal locomotor function, due in part to greater locomotor speeds, as compared to non-specific training strategies.
The aims represent an innovative approach to improving long-term mobility outcomes of patients with iSCI by applying selected principles of motor learning and exercise physiology yet untested in this population. Expected outcomes will be demonstration of the efficacy of a high intensity stepping training paradigm, with further understanding of potential underlying mechanisms and movement strategies used with improved locomotor performance. Successful completion of this project could have an immediate impact on rehabilitation research and treatment of people following iSCI, and may be utilized to treat more subacute patients with iSCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group with optional crossover
| Arm | Type | Receives |
|---|---|---|
| Variable Stepping Training | Experimental | Procedure: Variable Stepping TrainingHigh intensity stepping training in multiple environments, including overground, on a treadmill and on stairs. |
| Variable Non-specific Training | Active comparator | Procedure: Variable Non-specific TrainingHigh intensity non-stepping training, including balance, strength, and cycling tasks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- individuals with chronic (>1 yr duration) motor iSCI at the level or T10 (anatomical) or above
- ages 18-75 years
- ability to walk without physical assistance but with below-knee braces and assistive devices as needed
- self-selected gait speeds between 0.01-1.0 m/s.
- not currently receiving physical therapy
Key exclusion criteria (6 listed)
- uncontrolled cardiopulmonary or metabolic disease that limits exercise participation
- active heterotopic ossification
- recurrent history of lower extremity fractures
- previous orthopedic or other peripheral or central neurological injury that may impair locomotor function
- history of botulinum toxin injection < 3 months prior
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 |
|---|---|---|
| Variable Stepping TrainingSix weeks (20 sessions) of high intensity stepping training in multiple variable environments | Procedure or surgery | Variable Stepping Training |
| Variable Non-specific TrainingSix weeks (20 sessions) of high intensity stepping training in multiple variable environments | Procedure or surgery | Variable Non-specific Training |
Primary outcome
Walking Speed
Time frame: change in walking speed from baseline testing to post-testing following 6 weeks of training
fastest comfortable walking speed over short distances
1 secondary outcome
Walking Distance
Time frame: change in walking speed from baseline testing to post-testing following 6 weeks of training
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 14 Feb 2023.
- Individual participant dataSharing planned: No. Data available as requested
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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 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 Variable Stepping Training and Variable Non-specific 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 5 inclusion and 6 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 14 Feb 2023. 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?
Walking Speed (time frame: change in walking speed from baseline testing to post-testing following 6 weeks of training). 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 14 Feb 2023.