Walking Adaptability Post-Spinal Cord Injury

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT01851629

Collaborator

United States Department of Defense (U.S. Fed), Malcom Randall VA Medical Center (U.S. Fed), James A. Haley Veterans Administration Hospital (U.S. Fed), Brooks Rehabilitation (Other)

Enrollment

Locations

Arms

Duration (Months)

1.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Incomplete Spinal Cord Injury Brown Sequard Syndrome	Behavioral: Locomotor Training Other: Cross-Sectional Testing (No Intervention)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Locomotor Training Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.
Active Comparator: 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.	Behavioral: Locomotor Training Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.
Other: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Locomotor Training

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

Active Comparator: 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.

Behavioral: Locomotor Training

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

Other: 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.

Other: Cross-Sectional Testing (No Intervention)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).]
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 [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).]
Non-invasive protocols will be used to test a variety of reflexes that provide indirect measures related to the integrity of specific spinal pathways.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32608
2	Brain Rehabilitation Research Center, Malcom Randall VAMC	Gainesville	Florida	United States	32610
3	Brooks Rehabilitation	Jacksonville	Florida	United States	32216
4	James A. Haley VA Medical Center	Tampa	Florida	United States	33612