Clinical trial NCT01095380: Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques
Official title: Comparison of Post-SCI Locomotor Training Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injury
Keywords: task-specific training
walking
locomotion
function
body weight support
Individuals with motor-incomplete spinal cord injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-03-30
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Body weight supported (BWS) locomotor training improves overground walking ability in individuals with motor-incomplete spinal cord injury (SCI). While there are various approaches available for locomotor training, there is no consensus regarding which of these is optimal. The purpose of this ongoing investigation is to compare outcomes associated with these different training approaches.

Subjects and Methods: Subjects with chronic motor-incomplete SCI have completed training and initial and final testing. Subjects were randomly assigned to 1 of 4 different BWS assisted-stepping groups, including: 1) treadmill training with manual assistance (TM), 2) treadmill training with stimulation (TS), 3) overground training with stimulation (OG), or 4) treadmill training with robotic assistance (LR). Prior to and following participation the investigators assessed:

* Walking-related outcome measures: overground walking speed, training speed, step length and step symmetry.
* Spinal cord reflex activity
* Electromyographic (EMG) associated with walking

Hypotheses:

In individuals with incomplete spinal cord injury (SCI):

1. A 12-week period of body weight supported treadmill training with TS will produce improvements in walking function that are significantly greater than those produced by training with TM, OG, LR.
2. TS training will be associated with greater changes to spinal reflex activity than will be observed in subjects trained with manual assistance or non-assisted stepping. Changes to spinal reflex activation will be such that this activity more closely resembles that observed in non-disabled (ND) individuals.
3. Following participation in this walking regimen, EMG activity observed during walking in all groups will be more robust, more consistent and better coordinated than EMG measures obtained prior to training.


Eligibility criteria: Inclusion Criteria:

* motor-incomplete spinal cord injury (AIS C or D)
* at least one year post injury
* able to step with at at least one leg
* able to stand from chair with no more than moderate assist of 1 person

Exclusion Criteria:

* unstable neurologic status
* active orthopedic problem

Primary outcomes:
measure: Walking speed
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional walking capacity
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Edelle C Field-Fote, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Field-Fote EC, Lindley SD, Sherman AL. Locomotor training approaches for individuals with spinal cord injury: a preliminary report of walking-related outcomes. J Neurol Phys Ther. 2005 Sep;29(3):127-37. doi: 10.1097/01.npt.0000282245.31158.09.
citation: Field-Fote EC, Brown KM, Lindley SD. Influence of posture and stimulus parameters on post-activation depression of the soleus H-reflex in individuals with chronic spinal cord injury. Neurosci Lett. 2006 Dec 13;410(1):37-41. doi: 10.1016/j.neulet.2006.09.058. Epub 2006 Oct 12.
citation: Field-Fote EC, Dietz V. Single joint perturbation during gait: preserved compensatory response pattern in spinal cord injured subjects. Clin Neurophysiol. 2007 Jul;118(7):1607-16. doi: 10.1016/j.clinph.2007.03.022. Epub 2007 May 1.
citation: Ness LL, Field-Fote EC. Whole-body vibration improves walking function in individuals with spinal cord injury: a pilot study. Gait Posture. 2009 Nov;30(4):436-40. doi: 10.1016/j.gaitpost.2009.06.016. Epub 2009 Aug 3.
citation: Nooijen CF, Ter Hoeve N, Field-Fote EC. Gait quality is improved by locomotor training in individuals with SCI regardless of training approach. J Neuroeng Rehabil. 2009 Oct 2;6:36. doi: 10.1186/1743-0003-6-36.
citation: Sandler EB, Roach KE, Field-Fote EC. Dose-Response Outcomes Associated with Different Forms of Locomotor Training in Persons with Chronic Motor-Incomplete Spinal Cord Injury. J Neurotrauma. 2017 May 15;34(10):1903-1908. doi: 10.1089/neu.2016.4555. Epub 2017 Jan 4.