Spinal Cord Injury Clinical Trial
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.
;
Primary Purpose: Treatment
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