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Treadmill Training for Spinal Cord Injury Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Treadmill Training for Spinal Cord Injury conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Treadmill Training for Spinal Cord Injury Clinical research trials and Treadmill Training for Spinal Cord Injury health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Treadmill Training for Spinal Cord Injury. Treadmill Training for Spinal Cord Injury Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Treadmill Training for Spinal Cord Injury clinical trial. Test subjects typically receive the most expert healthcare available for their Treadmill Training for Spinal Cord Injury condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Treadmill Training for Spinal Cord Injury  Treadmill Training for Spinal Cord Injury
Treadmill Training for Spinal Cord Injury
For Condition: Spinal Cord Injury
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, patients will be partially supported through the use of a specially designed harness attached to an overhead lift (also called Body Weight Supported Treadmill Training, BWSTT). Patients who enroll in this study will be randomly assigned to either the experimental group, which receives 12 weeks of this specialized treadmill training with regular physical therapy, or to the control group, which receives 12 weeks regular physical therapy. The ability of the patients to "walk" will be measured before and after treatment as well as 6 and 12 months later, using standard tests that examine mobility independence and speed of ambulation. The trial takes place across five sites in the US and Canada. Patients eligible for this trial will have had a traumatic spinal cord injury within 8 weeks of trial entry.
Details: This is a 5-site randomized clinical trial of a task-oriented locomotor intervention for acute spinal cord injury (SCI). The intervention, body weight-supported treadmill training (BWSTT), partially supports the weight of the patient via an overhead lift attached to a harness. Therapists train the patient to walk on a treadmill by correcting gait deviations and manipulating sensory input that enhance control of the stance and swing phases of walking at increasingly higher speeds and less weight support. 100 patients with incomplete SCI (from below C4 to T10/11) and 100 patients with lesions at T12 to L3 will be randomly assigned to 12 weeks of conventional therapy programs for mobility versus the same intensity and duration of a combination of conventional therapy plus BWSTT. The primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet. Patients will be tested by masked examiners before and after the 12 weeks of therapy, and 6 and 12 months after entry into the study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Traumatic spinal cord injury (within 56 days) - Incomplete lesion: - ASIA C or D, from below C4 to L3 - ASIA B at or below C7 - Unable to ambulate over ground without at least moderate assistance (FIM locomotor 3 or less) - Able to offer at least 3/5 strength in elbow extensors - No clinically-significant cognitive impairment Exclusion Criteria: - Symptomatic fall in blood pressure greater than 30 mm Hg when upright - Halo or other cervical brace or TLSO (unless primary surgeon agrees) - Contraindication to weight bearing on lower extremities - Pressure sore with any skin breakdown below level of the SCI - Any debilitating disease prior to the acute SCI that would cause exercise intolerance - Premorbid, ongoing major depression or psychosis - Required use of anti-spasticity medication - Subject unlikely to complete intervention or return for follow-up
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
BruceDobkin, Principal Investigator, University of California at Los Angeles (UCLA)
Six Franklin Plaza *Recruiting*
Philadelphia, Pennsylvania, 19102
United States
Recruiting Mary Schmidt 215-587-3151
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Ann Smith 614-293-3809
University of Ottawa *Recruiting*
Ottawa, Ontario, K1H 8M2
Canada
Recruiting Michele Badour 1-613-737-7350
Shepherd Center *Recruiting*
Atlanta, Georgia, 30309
United States
Recruiting 404-350-7681
McGill University *Recruiting*
Montreal, Quebec, H3G 1Y5
Canada
Recruiting Christine Garneau 1-514-340-2090
Rancho Los Amigos Medical Center *Recruiting*
Downey, California, 90242
United States
Recruiting Claire Beekman 562-401-6244
Thomas Jefferson University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Mary Call 215-955-6579
Additional Information:
Study ID Numbers: NICHD-0103; U01 HD37439
Study Start Date: March 1999
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006429
Other Spinal Cord Injury Studies:
1. Evaluation of Robotic Upper Extremity Neuro-Rehabilitation
2. Clinical Evaluation of a Wheelchair Mounted Robotic Arm
3. Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury
4. Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
5. Mechanisms of Human Plasticity in the Human System
Related Studies:
Other Spinal Cord Injury Clinical Trials
Other Ontario Clinical Trials
Other Ottawa Clinical Trials
Treadmill Training for Spinal Cord Injury
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