Improving Gait in Patients With Spinal Cord Injuries
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Body weight supported locomotor training
Functional electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Locomotion, Spinal Cord Injury, ASIA C, Body weight support (BWS), Functional electrical stimulation (FES), Gait, Treadmill training, Physical Therapy
Eligibility Criteria
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)
Sites / Locations
- Miami Project, Bantle Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00060983
First Posted
May 16, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00060983
Brief Title
Improving Gait in Patients With Spinal Cord Injuries
Official Title
Effects of Sensory Motor Input on Gait in SCI (Spinal Cord Injured) Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Completed
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Locomotion, Spinal Cord Injury, ASIA C, Body weight support (BWS), Functional electrical stimulation (FES), Gait, Treadmill training, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Body weight supported locomotor training
Intervention Type
Procedure
Intervention Name(s)
Functional electrical stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edelle Carmen Field, Ph.D., P.T.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Project, Bantle Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.miamiproject.miami.edu/
Description
Click here for more information about the Miami Project to Cure Paralysis.
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Improving Gait in Patients With Spinal Cord Injuries
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