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

NCT01095380 | Completed Phase 2

• 1 other identifier: R01HD041487
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

task-specific training; walking; locomotion; function; body weight support; Individuals with motor-incomplete spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Walking speed

  Walking speed collected during 10-Meter Walk Test

  12 weeks

Secondary Outcomes (1)

• Functional walking capacity

  12 weeks

Study Arms (4)

Treadmill training - manual assist (TM)

ACTIVE COMPARATOR

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

Other: Locomotor training

Treadmill training - electrical stimulation (TS)

ACTIVE COMPARATOR

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

Other: Locomotor training

Overground Training (OG)

ACTIVE COMPARATOR

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

Other: Locomotor training

Treadmill training - locomat robot (LR)

ACTIVE COMPARATOR

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

Other: Locomotor training

Interventions

Locomotor training OTHER

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); Treadmill training - electrical stimulation (TS); Treadmill training - locomat robot (LR); Treadmill training - manual assist (TM)

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unstable neurologic status
• active orthopedic problem

Sponsors & Collaborators

• University of Miami: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Related Publications (6)

• 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.

  PMID: 16398945 RESULT

• 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.

  PMID: 17046161 RESULT

• 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.

  PMID: 17475549 RESULT

• 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.

  PMID: 19648013 RESULT

• 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.

  PMID: 19799783 RESULT

• 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.

  PMID: 27901413 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Edelle C Field-Fote, PT, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: November 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 30, 2010

Record last verified: 2009-01