Retraining Walking After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00059553

Recruitment Status : Unknown

Verified August 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Active, not recruiting

First Posted : April 29, 2003

Last Update Posted : June 18, 2009

Sponsor:

Collaborator:

VA Office of Research and Development

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description

Brief Summary:

Incomplete spinal cord injury often results in difficulty walking. Training on a treadmill with body weight support may improve walking ability after spinal cord injury. The purpose of this study is to examine the effect of treadmill speed on spinal cord function and walking performance.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries Quadriplegia Paraplegia Central Cord Syndrome Brown-Sequard Syndrome	Behavioral: Locomotor treadmill training with body weight support	Phase 2 Phase 3

Detailed Description:

Conventional rehabilitation following spinal cord injury (SCI) emphasizes functional gains through strengthening and compensation, using braces and assistive devices to achieve mobility. Rehabilitation practice using compensatory approaches is based on the prevailing assumption that neural recovery is not possible following SCI.

Recent evidence contradicts this assumption. Stimulated by the proper activation of peripheral afferents associated with walking, neuronal circuits may reorganize by strengthening of existing and previously inactive descending connections and local neural circuits. New approaches to locomotor recovery after SCI utilize sensory information related to locomotion to improve treadmill and overground walking.

Locomotor training velocity may be a critical, task-specific, and activity-dependent parameter affording appropriate phasic, afferent input to the neural system and promoting neural plasticity. The purpose of this study is to evaluate the effects of training velocity in a long-term locomotor training program on both neurophysiological and behavioral plasticity in individuals with incomplete SCI.

Sixteen patients with incomplete SCI will be recruited to participate in this study. Baseline evaluations will include American Spinal Injury Association classification, rate-sensitive depression, phase-dependent H-reflex modulation at self-selected and fast overground walking velocities, and MRI of the spine. Patients will wear a step activity monitor for a 48-hour period, quantifying baseline walking activity level.

All patients will participate in a locomotor training program. Patients will be randomly assigned to either training at self-selected treadmill velocity or at a normal walking velocity. Patients will have 45 training sessions over 9 weeks. Each training session will include 30 minutes of walking. Interim testing of rated depression, spatial-temporal parameters of walking, MRI, and walking activity will occur through the 9-week training period. Post-testing will occur within 2 days of the last training session and at a 1 month after completion of the training. During the month following long-term training, patients will be instructed to return to their self-selected routine activities of daily living.

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Activity-Dependent Plasticity After Spinal Cord Injury
Study Start Date :	May 2000
Study Completion Date :	January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Cord Injuries

Genetic and Rare Diseases Information Center resources: Paraplegia Brown-Sequard Syndrome

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

First time spinal cord injury (SCI) from trauma, vascular, or orthopedic pathology at cervical or thoracic levels
Category C or D SCI as defined by the American Spinal Injury Association (ASIA) Impairment Scale
1 to 3 years post-SCI
Ability to walk independently a minimum of 40 feet with or without an assistive device
Currently spending a minimum of 30 minutes per day walking
No change in anti-spasticity medication during the study
Medically stable
Participant's personal physician must verify the participant's medical status

Exclusion criteria:

Bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with training and testing of walking function or alter compliance with a training protocol
Currently participating in a rehabilitation program or another research protocol that could interfere or influence the outcome measures of the current study
Congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxia)
Other degenerative spinal disorders (e.g., spinocerebellar degeneration, syringomyelia) that may complicate the treatment or evaluation procedures

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059553

Locations


United States, Florida
University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

VA Office of Research and Development

Investigators


Principal Investigator:	Andrea L Behrman, PhD	University of Florida

More Information

Publications:

Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700. Review.

Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. Review.


ClinicalTrials.gov Identifier:	NCT00059553 History of Changes
Other Study ID Numbers:	K01HD001348 ( U.S. NIH Grant/Contract )
First Posted:	April 29, 2003 Key Record Dates
Last Update Posted:	June 18, 2009
Last Verified:	August 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):


spinal cord injury walking training treadmill incomplete spinal cord injury

Additional relevant MeSH terms:


Syndrome Wounds and Injuries Spinal Cord Injuries Paraplegia Quadriplegia Central Cord Syndrome Brown-Sequard Syndrome Disease	Pathologic Processes Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Paralysis Neurologic Manifestations Signs and Symptoms

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