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Walking Adaptability Post-Spinal Cord Injury

Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete Spinal Cord Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01851629
Enrollment
7
Registered
2013-05-10
Start date
2013-06-30
Completion date
2015-02-28
Last updated
2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incomplete Spinal Cord Injury, Brown Sequard Syndrome

Keywords

Locomotor training, Walking recovery, Neuroplasticity

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.

Interventions

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

OTHERCross-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.

Sponsors

United States Department of Defense
CollaboratorFED
Malcom Randall VA Medical Center
CollaboratorFED
James A. Haley Veterans Administration Hospital
CollaboratorFED
Brooks Rehabilitation
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in joint movement (Kinematics)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.

Secondary

MeasureTime frameDescription
Changes in falls risks during adaptive walking challengesAt 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
Changes in functional integrity of spinal pathwaysAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026