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Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
This study has been completed.
Study NCT00004812   Information provided by Office of Rare Diseases (ORD)
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
July 1995
 
 
 
Complete list of historical versions of study NCT00004812 on ClinicalTrials.gov Archive Site
 
 
 
Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
 

OBJECTIVES: I. Assess the ability of patients with and without sensorimotor loss below the thoracic spinal cord injury to execute coordinated whole-limb synergies sufficient for walking with full or partial weight support.

II. Promote weight bearing, balance, and reciprocal leg movement in these patients.

III. Elicit synchronized motor output within and between limbs in these patients.

PROTOCOL OUTLINE: This is a controlled, prospective study. Patients pairs matched for strata are randomly assigned to 1 of 2 treatment groups. Patients are stratified into pairs by age, time since onset, Frankel grade, and Motor Score Index.

One group receives body weight-supported treadmill training immediately after baseline clinical, biomechanical, and physiological measures. The second group is the control; baseline measures are identical but training is delayed for 3 months.

Patients in both groups receive training 3 days/week for 3 months. Initial treadmill velocity is 18 meters/minute; velocity is increased in increments of 6 meters/minute until the maximum speed is achieved at which each patient exhibits the best locomotor capability at full weight bearing. Patients are trained with the minimal weight support assistance necessary for effective limb progression without excessive knee flexion or hyperextension. Polypropylene ankle-foot orthosis is allowed.

Patients are re-tested after maximal treadmill velocity is achieved: following clonidine once a day for 3 days; clonidine twice a day for 3 days; cyproheptadine for 3 days; and an increased dose of cyproheptadine for 3 days. There is a 3-day washout between clonidine and cyproheptadine testing.

Patients are not advanced if they experience adverse cardiovascular effects during therapy. No concurrent therapeutic exercise for the lower extremities is allowed.

Kinematic, temporal, kinetic, spasticity, Frankel grading, Motor Index Score, metabolic, and functional outcome measures are evaluated at 3 and 6 months.

Phase II
Interventional
Treatment
Spinal Cord Injury
Behavioral: Exercise
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
26
 
 

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Traumatic or ischemic spinal cord injury Single lesion between thoracic vertebrae 1 and 12 Confirmed by computerized tomography or magnetic resonance imaging At least 12 months since onset of injury Motor recovery as follows: Ability to step not recovered OR Abnormal gait and maximum walking speed below one-half normal slow casual velocity of 60 meters/minute --Prior/Concurrent Therapy-- At least 3 months since completion of outpatient physical therapy Antispasticity agents tapered to lowest dose that limits flexor or extensor spasms interfering with sitting or comfort --Patient Characteristics-- Age: 16 to 60 Other: No clinically significant depression No drug abuse No urinary tract infection No painful musculoskeletal dysfunction, e.g., contracture or unhealed fracture No pressure sore No other medical contraindication to treadmill training, e.g.: Cardiopulmonary disease Dysautonomia

Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004812
 
199/12017, UCLA-9202060
National Institute of Neurological Disorders and Stroke (NINDS)
University of California, Los Angeles
Study Chair: Bruce Dobkin University of California, Los Angeles
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP