Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061295
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-23
Brief Title:
Treadmill Training With Body Weight Support in Patients With 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:
Body Weight Supported Ambulation Training After Spinal Cord Injury
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
RECRUITING
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:
Body weight support BWS treadmill training uses an overhead harness to give partial support to patients walking on a treadmill This study will determine whether BWS training is more effective than conventional rehabilitation therapy in improving walking ability in patients with spinal cord injuries SCI
Detailed Description:
Gait rehabilitation is a specific component of physical rehabilitation of persons with sub-acute or chronic spinal cord injury SCI One novel method of gait rehabilitation involves the use of an overhead support point and a harness The BWS strategy has been combined with treadmill-based gait training in recent studies with dramatic results It is believed that this form of training may enhance output of a central pattern generator of stepping movement from circuitry intrinsic to the patients spinal cord However only limited attention has been paid to the role that training-induced physical conditioning might play in mediating functional improvements
This study will evaluate whether BWS gait training is more effective than conventional rehabilitation therapy in improving functional gait in patients with neurologically incomplete spinal cord injury The study will also compare treadmill-based training to overground-based training Treadmill-based training has the inherent advantage of providing highly rhythmic input to the subjects legs overground-based training has the inherent advantage of allowing use of assistive devices and thereby replicating a more natural training condition
Patients with chronic SCI greater than 1 year post-injury and patients with sub-acute SCI 2 to 8 months post-injury will be evaluated Patients with chronic SCI will be randomly assigned to one of 3 groups body weight support and treadmill-based training body weight support and overground training and conventional rehabilitation therapy Patients with sub-acute injury will be randomized to receive either BWS treadmill training or conventional rehabilitation Training sessions are typically 1 hour long with 3 sessions per week for 13 weeks
All patients will be evaluated with a battery of functional metabolic and neurophysiologic measures prior to the onset of training and during the week after training has been completed The primary outcome measure will be average maximum overground walking velocity without body weight support but with the use of passive assistive devices Secondary measures will concentrate on function balance mobility fitness work capacity strength gait efficiency and spinal cord neurophysiology motor conduction reflex excitability
This study will evaluate whether BWS gait training is more effective than conventional rehabilitation therapy in improving functional gait in patients with neurologically incomplete spinal cord injury The study will also compare treadmill-based training to overground-based training Treadmill-based training has the inherent advantage of providing highly rhythmic input to the subjects legs overground-based training has the inherent advantage of allowing use of assistive devices and thereby replicating a more natural training condition
Patients with chronic SCI greater than 1 year post-injury and patients with sub-acute SCI 2 to 8 months post-injury will be evaluated Patients with chronic SCI will be randomly assigned to one of 3 groups body weight support and treadmill-based training body weight support and overground training and conventional rehabilitation therapy Patients with sub-acute injury will be randomized to receive either BWS treadmill training or conventional rehabilitation Training sessions are typically 1 hour long with 3 sessions per week for 13 weeks
All patients will be evaluated with a battery of functional metabolic and neurophysiologic measures prior to the onset of training and during the week after training has been completed The primary outcome measure will be average maximum overground walking velocity without body weight support but with the use of passive assistive devices Secondary measures will concentrate on function balance mobility fitness work capacity strength gait efficiency and spinal cord neurophysiology motor conduction reflex excitability
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