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

Phase 2

Completed

• Conditions: Spinal Cord Injury
• Interventions: Other: Locomotor training

• Registration Number: NCT01095380
• Lead Sponsor: University of Miami

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):

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

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-01
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Last Update Submitted: 2010-03-29
• Study First Posted: 2010-03-30
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treadmill training - manual assist (TM)	Locomotor training	Participants in the TM group received partial body weight support unilateral or bilateral manual assistance from a trainer for stepping
Treadmill training - electrical stimulation (TS)	Locomotor training	Participants in the TS group received partial body weight support and bilateral functional electrical stimulation to assist stepping
Overground Training (OG)	Locomotor training	Training over ground with body weight support and electrical stimulation for dorsiflex assistance
Treadmill training - locomat robot (LR)	Locomotor training	Treadmill training with partical body weight support and assistance of a robotic gait orthosis for stepping

Primary Outcome Measures

Name	Time	Method
Walking speed	12 weeks	Walking speed collected during 10-Meter Walk Test

Secondary Outcome Measures

Name	Time	Method
Functional walking capacity	12 weeks	Distance walked in timed 2-Minute Walk Test