Clinical trial NCT01851629: Walking Adaptability Post-Spinal Cord Injury
Official title: Adaptive Walking Responses Critical for Effective Community Ambulation Post-Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Brown Sequard Syndrome
Keywords: Locomotor training
Walking recovery
Neuroplasticity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Malcom Randall VA Medical Center
name: James A. Haley Veterans Administration Hospital
name: Brooks Rehabilitation
First posted: 2013-05-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in joint movement (Kinematics)
timeFrame: 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:
measure: Changes in falls risks during adaptive walking challenges
timeFrame: 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).
measure: Changes in functional integrity of spinal pathways
timeFrame: 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).
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Gainesville
country: United States
facility: Brain Rehabilitation Research Center, Malcom Randall VAMC
state: Florida
city: Jacksonville
country: United States
facility: Brooks Rehabilitation
state: Florida
city: Tampa
country: United States
facility: James A. Haley VA Medical Center
state: Florida
Study officials:
affiliation: University of Florida
name: Nicole J Tester, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Emily J. Fox, PhD, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Carolynn Patten, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: