Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury (DE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00127439
First received: August 3, 2005
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to collect data regarding the various aspects of locomotor training and how it affects different people with spinal cord injury (SCI).


Condition Intervention
Spinal Cord Injuries
Procedure: Manually Assisted Locomotor Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Differential Effects of Robotic vs. Manually-Assisted Locomotor Training

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Trunk and Limb Kinematics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Manually Assisted Locomotor Training
Individuals will receive 45 sessions of robotic or manually assisted locomotor training. The goal for each training session is to walk for no more than 30 minutes.

Detailed Description:

Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that intensive step training on a treadmill using body-weight support and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI.

The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training. Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults at least 18 years of age
  • SCI at least 6 months since injury
  • Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels
  • A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
  • SCI as defined by the American ASIA Impairment Scale categories C or D
  • Medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with the training protocol
  • Documented medical approval from the participant's personal physician verifying the participant's medical status at time of enrollment
  • Ability to walk a minimum of 30 feet with or without an assistive device, independently or with minimal assistance
  • Over ground gait speed < 0.8 m/s
  • Persons using anti-spasticity medication must maintain stable medication dosage during the study
  • Able to give informed consent

Exclusion Criteria:

  • Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
  • History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
  • Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality
  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: NCT00127439

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Investigators
Principal Investigator: Andrea Behrman, PT PhD North Florida/South Georgia Veterans Health System
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00127439     History of Changes
Other Study ID Numbers: B4024-I
Study First Received: August 3, 2005
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Ambulatory Disability
Disability Ambulation
Locomotion Disorders
Motor Activity
Rehabilitation
Spinal Cord Injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014