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Retraining Walking After Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Quadriplegia, Paraplegia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Locomotor treadmill training with body weight support
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, walking, training, treadmill, incomplete spinal cord injury

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 28, 2003
Last Updated
June 17, 2009
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00059553
Brief Title
Retraining Walking After Spinal Cord Injury
Official Title
Activity-Dependent Plasticity After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
US Department of Veterans Affairs

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Quadriplegia, Paraplegia, Central Cord Syndrome, Brown-Sequard Syndrome
Keywords
spinal cord injury, walking, training, treadmill, incomplete spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Locomotor treadmill training with body weight support

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L Behrman, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10869131
Citation
Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
Results Reference
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PubMed Identifier
9928326
Citation
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. doi: 10.1111/j.1749-6632.1998.tb09063.x.
Results Reference
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Retraining Walking After Spinal Cord Injury

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