Walking Adaptability Post-Spinal Cord Injury

Incomplete Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851629
• Other study ID #: 01-2013
• Secondary ID: W81XWH-11-1-0454
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: April 30, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brown Sequard Syndrome
• Brown-Sequard Syndrome
• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Behavioral:
• Locomotor Training
Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.

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.

Locations

Country	Name	City	State
United States	Brain Rehabilitation Research Center, Malcom Randall VAMC	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	Brooks Rehabilitation	Jacksonville	Florida
United States	James A. Haley VA Medical Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Florida	Brooks Center for Rehabilitation Studies, Malcom Randall VA Medical Center, Tampa VA Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	Changes in falls risks during adaptive walking challenges	Individuals will be tested on a special treadmill that perturbs walking and makes indirect measurements related to falls risks	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).	No
Secondary	Changes in functional integrity of spinal pathways	Non-invasive protocols will be used to test a variety of reflexes that provide indirect measures related to the integrity of specific 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).	No