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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Locomotor training
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring task-specific training, walking, locomotion, function, body weight support, Individuals with motor-incomplete spinal cord injury

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Treadmill training - manual assist (TM)

    Treadmill training - electrical stimulation (TS)

    Overground Training (OG)

    Treadmill training - locomat robot (LR)

    Arm Description

    Participants in the TM group received partial body weight support unilateral or bilateral manual assistance from a trainer for stepping

    Participants in the TS group received partial body weight support and bilateral functional electrical stimulation to assist stepping

    Training over ground with body weight support and electrical stimulation for dorsiflex assistance

    Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping

    Outcomes

    Primary Outcome Measures

    Walking speed
    Walking speed collected during 10-Meter Walk Test

    Secondary Outcome Measures

    Functional walking capacity
    Distance walked in timed 2-Minute Walk Test

    Full Information

    First Posted
    March 29, 2010
    Last Updated
    March 29, 2010
    Sponsor
    University of Miami
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01095380
    Brief Title
    Comparison of Post-pinal Cord Injury (SCI) Locomotor Training Techniques
    Official Title
    Comparison of Post-SCI Locomotor Training Techniques
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Miami
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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): 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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    task-specific training, walking, locomotion, function, body weight support, Individuals with motor-incomplete spinal cord injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treadmill training - manual assist (TM)
    Arm Type
    Active Comparator
    Arm Description
    Participants in the TM group received partial body weight support unilateral or bilateral manual assistance from a trainer for stepping
    Arm Title
    Treadmill training - electrical stimulation (TS)
    Arm Type
    Active Comparator
    Arm Description
    Participants in the TS group received partial body weight support and bilateral functional electrical stimulation to assist stepping
    Arm Title
    Overground Training (OG)
    Arm Type
    Active Comparator
    Arm Description
    Training over ground with body weight support and electrical stimulation for dorsiflex assistance
    Arm Title
    Treadmill training - locomat robot (LR)
    Arm Type
    Active Comparator
    Arm Description
    Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping
    Intervention Type
    Other
    Intervention Name(s)
    Locomotor training
    Intervention Description
    Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
    Primary Outcome Measure Information:
    Title
    Walking speed
    Description
    Walking speed collected during 10-Meter Walk Test
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Functional walking capacity
    Description
    Distance walked in timed 2-Minute Walk Test
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edelle C Field-Fote, PT, PhD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16398945
    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.
    Results Reference
    result
    PubMed Identifier
    17046161
    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.
    Results Reference
    result
    PubMed Identifier
    17475549
    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.
    Results Reference
    result
    PubMed Identifier
    19648013
    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.
    Results Reference
    result
    PubMed Identifier
    19799783
    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.
    Results Reference
    result
    PubMed Identifier
    27901413
    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.
    Results Reference
    derived

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

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