Walking Adaptability Post-Spinal Cord Injury

NCT01851629 | Completed DMC

• 2 other identifiers: 01-2013W81XWH-11-1-0454
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

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.

Conditions

Incomplete Spinal Cord Injury; Brown Sequard Syndrome

Keywords

Locomotor training; Walking recovery; Neuroplasticity

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Changes in falls risks during adaptive walking challenges

  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

  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).

Study Arms (3)

ADAPT Locomotor Training

EXPERIMENTAL

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

Basic Locomotor Training

ACTIVE COMPARATOR

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

Cross-Sectional Testing

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.

Other: Cross-Sectional Testing (No Intervention)

Interventions

Locomotor Training BEHAVIORAL

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

ADAPT Locomotor Training; Basic Locomotor Training

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.

Cross-Sectional Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

University of Florida

Gainesville, Florida, 32608, United States

Location

Brain Rehabilitation Research Center, Malcom Randall VAMC

Gainesville, Florida, 32610, United States

Location

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

James A. Haley VA Medical Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Brown-Sequard Syndrome

Condition Hierarchy (Ancestors)

Paraplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: May 10, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (4)