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Walking Adaptability Post-Spinal Cord Injury

Primary Purpose

Incomplete Spinal Cord Injury, Brown Sequard Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Locomotor Training
Cross-Sectional Testing (No Intervention)
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring Locomotor training, Walking recovery, Neuroplasticity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Florida
  • Brain Rehabilitation Research Center, Malcom Randall VAMC
  • Brooks Rehabilitation
  • James A. Haley VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

ADAPT Locomotor Training

Basic Locomotor Training

Cross-Sectional Testing

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in joint movement (Kinematics)
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
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
Non-invasive protocols will be used to test a variety of reflexes that provide indirect measures related to the integrity of specific spinal pathways.

Full Information

First Posted
April 24, 2013
Last Updated
April 30, 2015
Sponsor
University of Florida
Collaborators
United States Department of Defense, Malcom Randall VA Medical Center, James A. Haley Veterans Administration Hospital, Brooks Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT01851629
Brief Title
Walking Adaptability Post-Spinal Cord Injury
Official Title
Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
United States Department of Defense, Malcom Randall VA Medical Center, James A. Haley Veterans Administration Hospital, Brooks Rehabilitation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury, Brown Sequard Syndrome
Keywords
Locomotor training, Walking recovery, Neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADAPT Locomotor Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Basic Locomotor Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cross-Sectional Testing
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Locomotor Training
Intervention Description
Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.
Intervention Type
Other
Intervention Name(s)
Cross-Sectional Testing (No Intervention)
Intervention Description
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 Outcome Measure Information:
Title
Changes in joint movement (Kinematics)
Description
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.
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).
Secondary Outcome Measure Information:
Title
Changes in falls risks during adaptive walking challenges
Description
Individuals will be tested on a special treadmill that perturbs walking and makes indirect measurements related to falls risks
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).
Title
Changes in functional integrity of spinal pathways
Description
Non-invasive protocols will be used to test a variety of reflexes that provide indirect measures related to the integrity of specific 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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole J Tester, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily J. Fox, PhD, DPT, NCS
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolynn Patten, PhD, PT
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Brain Rehabilitation Research Center, Malcom Randall VAMC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Brooks Rehabilitation
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
James A. Haley VA Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Walking Adaptability Post-Spinal Cord Injury

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