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Completed

NCT Number: NCT01851629

Walking Adaptability Post-Spinal Cord Injury

The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to identify the functional integrity of long spinal tracts associated with adaptive walking recovery post-spinal cord injury and (2) to preliminary investigate locomotor outcomes associated with an adaptive locomotor training approach post-spinal cord injury.

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Key information

Conditions

Incomplete Spinal Cord Injury Brown Sequard Syndrome Brown-Sequard Syndrome Nervous System Diseases Neurologic Manifestations Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Rehabilitation Research Center, Malcom Randall VAMC, Gainesville, Florida, United States

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About this study

Eligible individuals without spinal cord injury that are enrolled in the study will participate for 1-2 days. These individuals may undergo a variety of non-invasive neurophysiological tests which evaluate spinal reflexes and integrity of specific spinal pathways. In addition, their movement may be assessed during walking on a treadmill and overground in a variety of different conditions (e.g. with mirrors, without mirrors, with obstacles, without obstacles).

Eligible individuals with spinal cord injury that are enrolled in the study will undergo the same testing as described above for the healthy controls. In addition, a small subset of these individuals may receive locomotor training (3 weeks of basic locomotor training followed by 3 weeks of adaptive locomotor training, separated by a 3 week washout period). For the individuals receiving locomotor training, they will be tested before and after each 3 week training session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • no neurologic injury (for individuals without SCI)
  • >12 mos post-incomplete SCI (iSCI), discharged from in- and out-patient rehabilitation, with diagnosis of first time motor iSCI (AIS C or D with upper motor neuron lesions at cervical or thoracic levels) (for individuals with SCI)
  • medically stable condition with no changes in anti-spasticity meds
  • ability to walk in the home and/or ambulate in the community using a single cane or crutch, bilateral canes or crutches, or no device
  • walking speeds > 0.3 m/sec, with deficit performance on the Dynamic Gait Index
  • medically approved for participation

Exclusion criteria

  • current participation in another rehabilitation program/research protocol
  • history of congenital SCI or other degenerative spinal disorders
  • inappropriate or unsafe fit of the harness and/or joint contractures or severe spasticity that would prohibit the safe provision of training
  • receipt of a therapeutic intervention or medication within the last 6 mos that would alter the nervous system's ability to respond to treatment (e.g. Botox injections)
  • unable to safely receive transcranial magnetic stimulation due to positive history which prohibits its use

Treatment and study plan

Locomotor Training

Behavioral

Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.

Cross-Sectional Testing (No Intervention)

Other

Individuals with and without spinal cord injury will be evaluated to develop protocols within our laboratory to assess reflexes (spinal tract integrity), walking ability, and whether mirror images during walking enhance or disrupt motor responses during walking.

Primary outcomes

  1. Changes in joint movement (Kinematics)

    Time frame: At approximately 0 weeks (pre-LT#1), 3 weeks (post-LT#1), 6 weeks (pre-LT#2) and 9 weeks (post-LT#2). Times may vary slightly if training sessions are missed (i.e. due to illness).

    During walking on the treadmill and overground, movement of lower extremity joints (hip, knee, and ankle) will be quantified using reflective markers and a 3D motion analysis system.

Secondary outcomes

  1. Changes in falls risks during adaptive walking challenges

    Time frame: At approximately 0 weeks (pre-LT#1), 3 weeks (post-LT#1), 6 weeks (pre-LT#2) and 9 weeks (post-LT#2). Times may vary slightly if training sessions are missed (i.e. due to illness).

    Individuals will be tested on a special treadmill that perturbs walking and makes indirect measurements related to falls risks

  2. Changes in functional integrity of spinal pathways

    Time frame: At approximately 0 weeks (pre-LT#1), 3 weeks (post-LT#1), 6 weeks (pre-LT#2) and 9 weeks (post-LT#2). Times may vary slightly if training sessions are missed (i.e. due to illness).

    Non-invasive protocols will be used to test a variety of reflexes that provide indirect measures related to the integrity of specific spinal pathways.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Brooks Rehabilitation
  • James A. Haley Veterans Administration Hospital
  • Malcom Randall VA Medical Center
  • United States Department of Defense

Registry information

Official study title

Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete Spinal Cord Injury

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 10, 2013
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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