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Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) trial: study protocol for an assessor blinded randomized controlled trial.

BMC neurology
January 1, 1970
Keith E Gordon et al. (7 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether locomotor training in a movement amplification environment improves walking balance and participation in walking activities more effectively than traditional treadmill training for people with incomplete spinal cord injury (iSCI).

Results Summary

The study hypothesizes that movement amplification during treadmill walking will enhance walking balance and participation in walking activities for individuals with iSCI, but results are not yet reported as the study is ongoing.

Population

Ambulatory participants with chronic incomplete spinal cord injury (iSCI)

Effective Dosage

20 locomotor training sessions

Duration

Not specified (number of sessions provided, but not duration in weeks/months)

Interactions

None mentioned

Extracted Claims (4)
InterventionDirectionEndpointPopulationDosageImpactClaim #
locomotor training in a movement amplification environment
increase
walking balance
ambulatory people with iSCI
-
will be more effective for improving
#1
locomotor training in a movement amplification environment
increase
participation in walking activities
ambulatory people with iSCI
-
will be more effective for improving
#2
locomotor training in a movement amplification environment
increase
balance impairments
people with iSCI
-
may result in new strategies for addressing
#3
intervention targeting walking balance
neutral
participation in walking activities
people with iSCI
-
affects
#4
Abstract

BACKGROUND: Among ambulatory people with incomplete spinal cord injury (iSCI), balance deficits are a primary factor limiting participation in walking activities. There is broad recognition that effective interventions are needed to enhance walking balance following iSCI. Interventions that amplify self-generated movements (e.g., error augmentation) can accelerate motor learning by intensifying sensorimotor feedback and facilitating exploration of motor control strategies. These features may be beneficial for retraining walking balance after iSCI. We have developed a cable-driven robot that creates a movement amplification environment during treadmill walking. The robot applies a continuous, laterally-directed, force to the pelvis that is proportional in magnitude to real-time lateral velocity. Our purpose is to investigate the effects of locomotor training in this movement amplification environment on walking balance. We hypothesize that for ambulatory people with iSCI, locomotor training in a movement amplification environment will be more effective for improving walking balance and participation in walking activities than locomotor training in a natural environment (no applied external forces). METHODS: We are conducting a two-arm parallel-assignment intervention. We will enroll 36 ambulatory participants with chronic iSCI. Participants will be randomized into either a control or experimental group. Each group will receive 20 locomotor training sessions. Training will be performed in either a traditional treadmill environment (control) or in a movement amplification environment (experimental). We will assess changes using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of walking balance, and 3) participation in walking activities quantified by number of steps taken per day. DISCUSSION: Training walking balance in people with iSCI by amplifying the individual's own movement during walking is a radical departure from current practice and may result in new strategies for addressing balance impairments. Knowledge gained from this study will expand our understanding of how people with iSCI improve walking balance and how an intervention targeting walking balance affects participation in walking activities. Successful outcomes could motivate development of clinically feasible tools to replicate the movement amplification environment within clinical settings. TRIAL REGISTRATION: NCT04340063.

Medical Subject Headings (MeSH)
AdultFemaleHumansMaleMiddle AgedExercise TherapyGaitLocomotionPostural BalanceRoboticsSingle-Blind MethodSpinal Cord InjuriesWalkingRandomized Controlled Trials as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Research Impact Scores
APT Score0.05
Weight Score1.39
Normalized Score0.67
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