Health Outcomes After Locomotor Training in Spinal Cord Injury

April 2, 2019 updated by: Sue Ann Sisto, Stony Brook University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Craig Hospital
    • Kentucky
      • Louisville, Kentucky, United States
        • Frazier Rehab
    • New York
      • Stony Brook, New York, United States, 11794-6018
        • Rehabilitation Research and Movement Performance Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Anti-spasticity medication except night time dose.
  • The use of chemodenervation for spasticity will be avoided for the 3 months prior to NRN admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Locomotor Training
Behavioral: Locomotor Training
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and after 80 sessions of Locomotor Training (LT). If continuous sessions are attended then 5d X 16 weeks or 4 months = 80 sessions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stony Brook University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ohio State University
University of Louisville
TIRR Memorial Hermann
Kessler Institute for Rehabilitation
Craig Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 376696

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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