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

March 29, 2010 updated by: University of Miami

Comparison of Post-SCI Locomotor Training Techniques

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

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Interventional

Enrollment (Actual)

Enrollment

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74

Phase

Phase

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  • Phase 2
  • Phase 3

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: 12 weeks
Walking speed collected during 10-Meter Walk Test
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional walking capacity
Time Frame: 12 weeks
Distance walked in timed 2-Minute Walk Test
12 weeks

Collaborators and Investigators

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Sponsor

Sponsor

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University of Miami

Collaborators

Collaborators

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

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

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November 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

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March 30, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2009

More Information

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Other Study ID Numbers

Other Study ID Numbers

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  • R01HD041487 (NIH)

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