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

NCT ID: NCT01095380

Last Updated: 2010-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-11-30

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Locomotor training

Intervention Type OTHER

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

Treadmill training - electrical stimulation (TS)

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

Group Type ACTIVE_COMPARATOR

Locomotor training

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Locomotor training

Intervention Type OTHER

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

Treadmill training - locomat robot (LR)

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

Group Type ACTIVE_COMPARATOR

Locomotor training

Intervention Type OTHER

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

Interventions

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Locomotor training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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University of Miami Miller School of Medicine

Principal Investigators

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Edelle C Field-Fote, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

References

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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.

Reference Type RESULT
PMID: 16398945 (View on PubMed)

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.

Reference Type RESULT
PMID: 17046161 (View on PubMed)

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.

Reference Type RESULT
PMID: 17475549 (View on PubMed)

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.

Reference Type RESULT
PMID: 19648013 (View on PubMed)

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.

Reference Type RESULT
PMID: 19799783 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27901413 (View on PubMed)

Other Identifiers

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R01HD041487

Identifier Type: NIH

Identifier Source: org_study_id

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