NCT00059553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

June 18, 2009

Status Verified

August 1, 2005

First QC Date

April 28, 2003

Last Update Submit

June 17, 2009

Conditions

Keywords

spinal cord injurywalkingtrainingtreadmillincomplete spinal cord injury

Interventions

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

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

    PMID: 10869131BACKGROUND
  • 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.

    PMID: 9928326BACKGROUND

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegiaParaplegiaCentral Cord SyndromeBrown-Sequard Syndrome

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea L Behrman, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 28, 2003

First Posted

April 29, 2003

Study Start

May 1, 2000

Study Completion

January 1, 2005

Last Updated

June 18, 2009

Record last verified: 2005-08

Locations