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

Comparison of Post-SCI Locomotor Training Techniques

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01095380
Enrollment
74
Registered
2010-03-30
Start date
2003-11-30
Completion date
2008-11-30
Last updated
2010-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

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

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.

Interventions

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Walking speed12 weeksWalking speed collected during 10-Meter Walk Test

Secondary

MeasureTime frameDescription
Functional walking capacity12 weeksDistance walked in timed 2-Minute Walk Test

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026