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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

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
Intervention / Treatment
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

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

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (ESTIMATE)

March 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD041487 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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