Walking Adaptability Post-Spinal Cord Injury

April 30, 2015 updated by: University of Florida

Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Gainesville, Florida, United States, 32610
        • Brain Rehabilitation Research Center, Malcom Randall VAMC
      • Jacksonville, Florida, United States, 32216
        • Brooks Rehabilitation
      • Tampa, Florida, United States, 33612
        • James A. Haley VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

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

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (ESTIMATE)

May 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-2013
  • W81XWH-11-1-0454 (OTHER_GRANT: Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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