Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques
NCT ID: NCT01095380
Last Updated: 2010-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
74 participants
INTERVENTIONAL
2003-11-30
2008-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treadmill training - manual assist (TM)
Participants in the TM group received partial body weight support unilateral or bilateral manual assistance from a trainer for stepping
Locomotor training
Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
Treadmill training - electrical stimulation (TS)
Participants in the TS group received partial body weight support and bilateral functional electrical stimulation to assist stepping
Locomotor training
Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
Overground Training (OG)
Training over ground with body weight support and electrical stimulation for dorsiflex assistance
Locomotor training
Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
Treadmill training - locomat robot (LR)
Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping
Locomotor training
Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
Interventions
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Locomotor training
Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
Eligibility Criteria
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Inclusion Criteria
* 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
* active orthopedic problem
16 Years
65 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Miami
OTHER
Responsible Party
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University of Miami Miller School of Medicine
Principal Investigators
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Edelle C Field-Fote, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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