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.|
|ClinicalTrials.gov Identifier: NCT00060983|
Recruitment Status : Completed
First Posted : May 19, 2003
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Procedure: Body weight supported locomotor training Procedure: Functional electrical stimulation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00060983
|United States, Florida|
|Miami Project, Bantle Center|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Edelle Carmen Field, Ph.D., P.T.||University of Miami|