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

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ClinicalTrials.gov Identifier: NCT01095380
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Miami

Tracking Information
First Submitted Date  ICMJE March 29, 2010
First Posted Date  ICMJE March 30, 2010
Last Update Posted Date March 30, 2010
Study Start Date  ICMJE November 2003
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Walking speed [ Time Frame: 12 weeks ]
Walking speed collected during 10-Meter Walk Test
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Functional walking capacity [ Time Frame: 12 weeks ]
Distance walked in timed 2-Minute Walk Test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques
Official Title  ICMJE Comparison of Post-SCI Locomotor Training Techniques
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Other: Locomotor training
  • Active Comparator: Treadmill training - electrical stimulation (TS)
    Participants in the TS group received partial body weight support and bilateral functional electrical stimulation to assist stepping
    Intervention: Other: Locomotor training
  • Active Comparator: Overground Training (OG)
    Training over ground with body weight support and electrical stimulation for dorsiflex assistance
    Intervention: Other: Locomotor training
  • Active Comparator: Treadmill training - locomat robot (LR)
    Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping
    Intervention: Other: Locomotor training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2010)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01095380
Other Study ID Numbers  ICMJE R01HD041487( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edelle Field-Fote, Professor, University of Miami Miller School of Medicine
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Edelle C Field-Fote, PT, PhD University of Miami
PRS Account University of Miami
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP