Spinal Cord InjuriesNCT02201173
Health Outcomes After Locomotor Training in Spinal Cord Injury
A study testing Locomotor Training in people with Spinal Cord Injuries and Spinal Cord Trauma, run by Stony Brook University at 3 sites in United States.
Trial summary
People with spinal cord injury (SCI) suffer from secondary health conditions that can result in undue physical challenges and impact participation in activities in everyday life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Trauma
- What is being tested?
- Locomotor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2014to 28 Feb 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are classified as AIS C and D must have some lower limb movement or visible voluntary contraction and the capacity to generate a lower limb reciprocal alternating flexion/extension stepping pattern in the step training environment using body weight support on a treadmill with manual facilitation.
- Patients with AIS A and B need to be able to stand in the BWS harness system without orthostatic hypotension for at least 1 minute.
Who cannot join
- Anti-spasticity medication except night time dose.
- The use of chemodenervation for spasticity will be avoided for the 3 months prior to NRN admission.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Craig Hospital
Englewood, Colorado, 80113
Frazier Rehab
Louisville, Kentucky
Rehabilitation Research and Movement Performance Lab
Stony Brook, New York, 11794-6018
About this study
Official title: Health Outcomes After Locomotor Training in Spinal Cord Injury Across the NeuroRecovery Network
People with spinal cord injury (SCI) suffer from secondary health conditions that can result in undue physical challenges and impact participation in activities in everyday life. Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking function in both the animal and humans by reactivating spinal circuits through intensive therapy of muscles below the level of the injury. However, it is not known if LT also has beneficial health effects and it is the focus of this study proposed to be undertaken at Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal networks to help recover balance and walking after SCI and may correspond with improvements in health measures such as bladder function, breathing capacity, cholesterol and other cardiac risk factors markers, and the ability to stand upright without drops in blood pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body weight supported in a harness, while walking overground and with the practice of key exercises in the home and community. The emphasis is on loading the body through the legs without braces and other devices except where necessary to function at home. The overall objective of this study to capture and analyze health outcome data collected on 80 patients enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people with SCI. The purpose of this application is to leverage the NRN funding, that provides support for LT and standardized outcome measures, to generate further knowledge on health outcomes after LT for individuals with SCI. The proposed project will be accomplished through the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator and the lead clinical research coordinator at SBU. They will ensure the data are captured before and after LT in a standardized manner, at the correct time and entered into a de-identified database. The study hypotheses are that after LT, compared to before, patients with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests; respiratory function as measured by specialized but easy to use breathing equipment; and blood pressure and heart rate during a maneuver to test for responses to abrupt changes in posture. The relevance of this proposal is that it will help to determine if there is an association between an intensive activity- based intervention (LT) and improvements in health and will be used to form the basis for a larger randomized clinical trial and clinical practice guidelines.
- Conditions
- Spinal Cord Injuries, Spinal Cord Trauma
- Being tested
- Locomotor 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.
Locomotor TrainingBehavioural
Progressive retraining in functional skills including balance, transfers, activities of daily living and ambulation. Compliance to eliminate or minimize lower limb orthotics is also expected to optimize sensory input to the spinal cord and promote optimal recovery. Intensive therapy occurs in all three environments 5 times/ week for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Locomotor Training | Experimental | Not described Receives: Behavioral: Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Assays
Study supplements the Locomotor Training program sponsored by the NeuroRecovery Network except for this new study where blood is drawn before and after Locomotor Training (LT)
Measured: Baseline and after 80 sessions of Locomotor Training (LT). If continuous sessions are attended then 5d X 16 weeks or 4 months = 80 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Kessler Institute for Rehabilitation, TIRR Memorial Hermann, University of Louisville, Craig Hospital
- Responsible party
- Principal investigator, Sue Ann Sisto, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201173
- Sponsor's protocol ID
- 376696
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2014
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes After Locomotor Training in Spinal Cord Injury Across the NeuroRecovery Network
- ClinicalTrials.gov ID
- NCT02201173
- Acronym / sponsor ID
- 376696
- Conditions
- Spinal Cord Injuries, Spinal Cord Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Ohio State University, Kessler Institute for Rehabilitation, TIRR Memorial Hermann, University of Louisville, Craig Hospital
- Study start
- Jul 2014
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
People with spinal cord injury (SCI) suffer from secondary health conditions that can result in undue physical challenges and impact participation in activities in everyday life. Locomotor Training (LT) has been shown to demonstrate improvements in balance and walking function in both the animal and humans by reactivating spinal circuits through intensive therapy of muscles below the level of the injury. However, it is not known if LT also has beneficial health effects and it is the focus of this study proposed to be undertaken at Stony Brook University (SBU) as the lead site. LT is thought to produce activation of spinal networks to help recover balance and walking after SCI and may correspond with improvements in health measures such as bladder function, breathing capacity, cholesterol and other cardiac risk factors markers, and the ability to stand upright without drops in blood pressure resulting in a sensation of dizziness. LT takes place on a treadmill with the body weight supported in a harness, while walking overground and with the practice of key exercises in the home and community. The emphasis is on loading the body through the legs without braces and other devices except where necessary to function at home. The overall objective of this study to capture and analyze health outcome data collected on 80 patients enrolled in the 7 NeuroRecovery Network (NRN) clinics in the USA who receive LT. The NRN is funded by the Christopher and Dana Reeve Foundation and the CDC to implement LT for people with SCI. The purpose of this application is to leverage the NRN funding, that provides support for LT and standardized outcome measures, to generate further knowledge on health outcomes after LT for individuals with SCI. The proposed project will be accomplished through the utilization of staff at each of the 6 NRN sites, lead by the study principal investigator and the lead clinical research coordinator at SBU. They will ensure the data are captured before and after LT in a standardized manner, at the correct time and entered into a de-identified database. The study hypotheses are that after LT, compared to before, patients with SCI will improve lipid profiles and insulin factors as measured by fasting blood tests; respiratory function as measured by specialized but easy to use breathing equipment; and blood pressure and heart rate during a maneuver to test for responses to abrupt changes in posture. The relevance of this proposal is that it will help to determine if there is an association between an intensive activity- based intervention (LT) and improvements in health and will be used to form the basis for a larger randomized clinical trial and clinical practice guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locomotor Training | Experimental | Behavioral: Locomotor Training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are classified as AIS C and D must have some lower limb movement or visible voluntary contraction and the capacity to generate a lower limb reciprocal alternating flexion/extension stepping pattern in the step training environment using body weight support on a treadmill with manual facilitation.
- Patients with AIS A and B need to be able to stand in the BWS harness system without orthostatic hypotension for at least 1 minute.
Key exclusion criteria (2 listed)
- Anti-spasticity medication except night time dose.
- The use of chemodenervation for spasticity will be avoided for the 3 months prior to NRN admission.
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 |
|---|---|---|
| Locomotor TrainingProgressive retraining in functional skills including balance, transfers, activities of daily living and ambulation. Compliance to eliminate or minimize lower limb orthotics is also expected to optimize sensory input to the spinal cord and promote optimal recovery. Intensive therapy occurs in all three environments 5 times/ week for 90 minutes | Behavioural | Locomotor Training |
Primary outcome
Blood Assays
Time frame: Baseline and after 80 sessions of Locomotor Training (LT). If continuous sessions are attended then 5d X 16 weeks or 4 months = 80 sessions.
Study supplements the Locomotor Training program sponsored by the NeuroRecovery Network except for this new study where blood is drawn before and after Locomotor Training (LT)
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 4 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locomotor Training in people with Spinal Cord Injuries and Spinal Cord Trauma, run by Stony Brook University at 3 sites 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 2 inclusion and 2 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Blood Assays (time frame: Baseline and after 80 sessions of Locomotor Training (LT). If continuous sessions are attended then 5d X 16 weeks or 4 months = 80 sessions.). 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 4 Apr 2019.