Health Outcomes After Locomotor Training in Spinal Cord Injury



Status:Completed
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 80
Updated:4/6/2019
Start Date:July 2014
End Date:February 28, 2018

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
3
sites
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Englewood, Colorado 80113
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Louisville, Kentucky
?
mi
from
Louisville, KY
Click here to add this to my saved trials