Walking Adaptability Post-Spinal Cord Injury

NCT ID: NCT01851629

Last Updated: 2015-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Incomplete Spinal Cord Injury Brown Sequard Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Locomotor Training

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Locomotor Training

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Cross-Sectional Testing (No Intervention)

Intervention Type 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.

Interventions

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Locomotor Training

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

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Malcom Randall VA Medical Center

FED

Sponsor Role collaborator

James A. Haley Veterans Administration Hospital

FED

Sponsor Role collaborator

Brooks Rehabilitation

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole J Tester, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Emily J. Fox, PhD, DPT, NCS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Carolynn Patten, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Brain Rehabilitation Research Center, Malcom Randall VAMC

Gainesville, Florida, United States

Site Status

Brooks Rehabilitation

Jacksonville, Florida, United States

Site Status

James A. Haley VA Medical Center

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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W81XWH-11-1-0454

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01-2013

Identifier Type: -

Identifier Source: org_study_id

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