Trial record 5 of 273 for:    Central Cord Syndrome

Retraining Walking After Spinal Cord Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00059553
First received: April 28, 2003
Last updated: June 17, 2009
Last verified: August 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Activity-Dependent Plasticity After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 16
Study Start Date: May 2000
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059553

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Investigators
Principal Investigator: Andrea L Behrman, PhD University of Florida
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00059553     History of Changes
Other Study ID Numbers: K01HD01348
Study First Received: April 28, 2003
Last Updated: June 17, 2009
Health Authority: United States: Federal Government

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:
Retinitis Pigmentosa
Syndrome
Spinal Cord Injuries
Central Cord Syndrome
Brown-Sequard Syndrome
Spinal Cord Diseases
Central Nervous System Diseases
Paraplegia
Quadriplegia
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Disease
Pathologic Processes
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014