Treadmill Training With Body Weight Support in Patients With Spinal Cord Injury
NCT ID: NCT00061295
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
INTERVENTIONAL
1999-03-31
2004-02-29
Brief Summary
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Detailed Description
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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 subject's 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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Interventions
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Body weight support treadmill training
Eligibility Criteria
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Inclusion Criteria
* 1 year post injury
* Some volitional movement in one or both limbs (i.e., motor incomplete)
* Ability to stand with limited bracing
* Ability to rise from sit to stand with no more that moderate assistance
* Spinal cord injury at or above the T10 spine
* 2 to 8 months post injury
* Volitional movement in at least one lower limb muscle (i.e., motor incomplete), although may not be capable of unsupported standing or moving from sit-to-stand without maximal assistance
Exclusion Criteria
* Neoplastic, degenerative, or vascular disorders of the spine or spinal cord
* Significant orthopaedic conditions that would interfere with regular exercise or rehabilitation therapy
* Decubitus ulcer
* Advanced urinary tract infection
* Medical conditions that increase the probability of having a seizure in response to single pulse transcranial magnetic stimulation
16 Years
70 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Blair M. Calancie
Role: PRINCIPAL_INVESTIGATOR
University of Miami Project to Cure Paralysis
Locations
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Upstate Medical University
Miami, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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