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Improving Gait in Patients With Spinal Cord Injuries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00060983
Recruitment Status : Completed
First Posted : May 19, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
This study is part of a larger clinical trial that examines the potential of a 12-week treadmill-training program to improve walking in patients with spinal cord injuries (SCIs). Patients in the trial are at least 1 year past their injury. This substudy tests a combination of two strategies to enhance the treadmill training program: electrically stimulating a muscle withdrawal reflex and providing body weight support by partially suspending patients as they walk on the treadmill.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Procedure: Body weight supported locomotor training Procedure: Functional electrical stimulation Phase 2

Detailed Description:

Patients with spastic paresis due to incomplete SCI have inadequate motor control of the lower extremities that results in a number of abnormalities of movement. Among these are unregulated spinal reflexes, inadequate and delayed motor recruitment, and balance deficits. If the patient can walk, these abnormalities manifest in a gait pattern that has poorly coordinated timing between different muscle groups, decreased weight bearing capacity, and inappropriate muscle activity, such as scissoring.

Research in patients with SCIs has demonstrated that, despite the damage to the spinal cord, many of the nervous system pathways that control walking remain intact and can be activated by the proper sensory stimulation. Two technologies that may enhance the benefits of treadmill walking are body weight support (BWS) and functional electrical stimulation (FES). Preliminary studies indicate that by combining these two interventions, gait performance is improved such that more efficient and functional movement emerges. This study will evaluate the benefits of adding BWS and FES to a treadmill-training program for patients with SCIs.

During the treadmill training, patients are suspended in an apparatus to provide partial body weight support (BWS). The training effects of BWS locomotion with FES over the course of a multi-session training program will be examined. Study visits will be scheduled 3 days each week for 12 weeks. Participants will have follow-up visits at Months 3 and 12. Gait parameters modified by training will be identified and the nature of these changes will be characterized. Specifically, walking speed, kinematics, electromyography (EMG), and muscle strength will be assessed.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effects of Sensory Motor Input on Gait in SCI (Spinal Cord Injured) Subjects
Study Start Date : May 1998
Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Spinal cord injury classified as American Spinal Injury Association (ASIA) C
  • At least 1 year post injury

Exclusion Criteria:

  • Spinal cord injuries of other severities (classified ASIA A, B, D, or E)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060983

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United States, Florida
Miami Project, Bantle Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Edelle Carmen Field, Ph.D., P.T. University of Miami

Additional Information:
Layout table for additonal information Identifier: NCT00060983    
Other Study ID Numbers: 5K01HD001193-02 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2003
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Spinal Cord Injury, ASIA C
Body weight support (BWS)
Functional electrical stimulation (FES)
Treadmill training
Physical Therapy
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System