Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques

Spinal Cord Injury Clinical Trial

Official title:

Comparison of Post-SCI Locomotor Training Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095380
• Other study ID #: R01HD041487
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 29, 2010
• Last updated: March 29, 2010
• Start date: November 2003
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Locomotor training
Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

References & Publications (5)

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. Epub 2006 Oct 12. — View 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. Epub 2007 May 1. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	Walking speed collected during 10-Meter Walk Test	12 weeks	No
Secondary	Functional walking capacity	Distance walked in timed 2-Minute Walk Test	12 weeks	No