Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006429
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2000-11-01
Brief Title:
Treadmill Training for Spinal Cord Injury
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Locomotor Therapy Trial for Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2011-05
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:
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
Detailed Description:
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 T1011 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD037439 | NIH | None | httpsreporternihgovquickSearchU01HD037439 |