Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004812
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
II Promote weight bearing balance and reciprocal leg movement in these patients
III Elicit synchronized motor output within and between limbs in these patients
Detailed Description:
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 daysweek for 3 months Initial treadmill velocity is 18 metersminute velocity is increased in increments of 6 metersminute 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
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 daysweek for 3 months Initial treadmill velocity is 18 metersminute velocity is increased in increments of 6 metersminute 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-9202060 | None | None | None |