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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01095380
First received: March 29, 2010
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Spinal Cord Injury
Other: Locomotor training
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Post-SCI Locomotor Training Techniques

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Walking speed [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Walking speed collected during 10-Meter Walk Test


Secondary Outcome Measures:
  • Functional walking capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Distance walked in timed 2-Minute Walk Test


Enrollment: 74
Study Start Date: November 2003
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
Active Comparator: Overground Training (OG)
Training over ground with body weight support and electrical stimulation for dorsiflex assistance
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
Active Comparator: Treadmill training - locomat robot (LR)
Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping
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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095380

Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Edelle C Field-Fote, PT, PhD University of Miami
  More Information

Publications:
Responsible Party: Edelle Field-Fote, Professor, University of Miami Miller School of Medicine
ClinicalTrials.gov Identifier: NCT01095380     History of Changes
Other Study ID Numbers: R01HD41487
Study First Received: March 29, 2010
Last Updated: March 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
task-specific training
walking
locomotion
function
body weight support
Individuals with motor-incomplete spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 11, 2014