Trial record 2 of 2 for:    "Brown-Sequard syndrome"

Walking Adaptability Post-Spinal Cord Injury

This study is currently recruiting participants.
Verified March 2014 by University of Florida
Sponsor:
Collaborators:
Malcom Randall VA Medical Center
Tampa VA Medical Center
Brooks Center for Rehabilitation Studies
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01851629
First received: April 24, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Incomplete Spinal Cord Injury
Brown Sequard Syndrome
Behavioral: Locomotor Training
Other: Cross-Sectional Testing (No Intervention)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Individuals will be tested on a special treadmill that perturbs walking and makes indirect measurements related to falls risks

  • 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). ] [ Designated as safety issue: No ]
    Non-invasive protocols will be used to test a variety of reflexes that provide indirect measures related to the integrity of specific spinal pathways.


Estimated Enrollment: 64
Study Start Date: June 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADAPT Locomotor Training
Individuals receive 15 sessions of ADAPT-locomotor training for 3 weeks. During ADAPT-locomotor training, stepping in response to obstacles and walking challenges are practiced on a treadmill and overground.
Behavioral: Locomotor Training
Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.
Active Comparator: Basic Locomotor Training
Individuals will receive 15sessions of the traditional form of basic locomotor training for 3 weeks. Repetitive stepping patterns are practiced on the treadmill and overground.
Behavioral: Locomotor Training
Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.
Cross-Sectional Testing
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.
Other: Cross-Sectional Testing (No Intervention)
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851629

Contacts
Contact: Nicole J Tester, PhD 352-376-1611 ext 7507 ntester@phhp.ufl.edu
Contact: Emily J Fox, PhD, DPT, NCS 352-273-6117 ejfox@phhp.ufl.edu

Locations
United States, Florida
Brain Rehabilitation Research Center, Malcom Randall VAMC Recruiting
Gainesville, Florida, United States, 32610
Contact: Nicole J. Tester, PhD    352-376-1611 ext 7505    ntester@phhp.ufl.edu   
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Nicole J. Tester, PhD    352-376-1611 ext 7507    ntester@phhp.ufl.edu   
Contact: Emily J. Fox, PhD, DPT, NCS    352-273-6117    ejfox@phhp.ufl.edu   
Brooks Rehabilitation Recruiting
Jacksonville, Florida, United States, 32216
Contact: Emily J. Fox, PhD, PT, NCS    352-273-6117    ejfox@phhp.ufl.edu   
James A. Haley VA Medical Center Recruiting
Tampa, Florida, United States, 33612
Contact: M. Raquel Elliot, OT    813-558-3981      
Sponsors and Collaborators
University of Florida
Malcom Randall VA Medical Center
Tampa VA Medical Center
Brooks Center for Rehabilitation Studies
Investigators
Principal Investigator: Nicole J Tester, PhD University of Florida
Principal Investigator: Emily J. Fox, PhD, DPT, NCS University of Florida
Principal Investigator: Carolynn Patten, PhD, PT University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01851629     History of Changes
Other Study ID Numbers: 01-2013, W81XWH-11-1-0454
Study First Received: April 24, 2013
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Locomotor training
Walking recovery
Neuroplasticity

Additional relevant MeSH terms:
Brown-Sequard Syndrome
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paraplegia
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014