Back to results

Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)

Primary Purpose

Spinal Cord Injury (SCI)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Locomotor Training

About this trial

This is an interventional treatment trial for Spinal Cord Injury (SCI) focused on measuring walking, walking recovery, physical therapy, locomotor training, body weight support, neuroplasticity, step, treadmill, treadmill training, locomotion

Eligibility Criteria

3 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals with SCI will include:

Pre-adolescent children, ages 3-13 yrs old
A diagnosis of first time, non-progressive SCI, upper motor neuron lesion, including, but not limited to, etiology from trauma, inflammation, vascular, surgical re-section due to localized tumor removal or orthopedic pathology resulting in clinical signs of lower cervical or thoracic spinal cord injury
Non-ambulatory or impaired ambulation for greater than 1 yr, such that physical assistance and the use of assistive devices (i.e. walker) and/or leg braces (i.e. knee- ankle- foot orthoses (KAFOs)) are required to ambulate
A SCI as defined by the American Spinal Injury Association (ASIA) Impairment Scale category B or C
A medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with a training protocol
Documented medical approval from the participant's personal physician verifying the participant's medical status
Parent's informed consent for children

Exclusion Criteria

Children with SCI who -

Are currently participating in a rehabilitation program or another research protocol that could interfere or influence the outcome measures of the current study
Have a history of congenital SCI (e.g. Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration or syringomyelia) that may complicate the treatment and/or evaluation procedures
Children who are diabetic or have implants, pacemakers, or devices which are not NMR/MRI compatible and are not suitable for the study

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kids Step Study: Locomotor Training

Arm Description

All children who participate will be in the experimental cohort, KSS-#, and receive 60 sessions of daily locomotor training. This experimental cohort will also undergo clinical and neurophysiological testing pre, during, and post 60 sessions of locomotor training.

Outcomes

Primary Outcome Measures

Recovery of walking, assessed in treadmill/ BWS environment and overground

Secondary Outcome Measures

Amount of daily step activity

Walking independence, WISCI II

Stepping assessment and kinematic analysis

Analysis of locomotor tasks such as crawling, swimming, cycling

Self-selected and fast gait speed

Spinal MRI to assess injury

Spinal reflex assessment (H reflex)

Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)

Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion

Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation

Full Information

NCT ID

NCT00488280

First Posted

June 19, 2007

Last Updated

January 7, 2013

Sponsor

University of Florida

Collaborators

The Craig H. Neilsen Foundation, Brooks Rehabilitation, Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00488280

Brief Title

Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)

Official Title

Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

The Craig H. Neilsen Foundation, Brooks Rehabilitation, Baylor College of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The Kids STEP Study aims to Determine if walking can be restored in children with incomplete SCI and little to no leg movement Identify the neural pathways that permit recovery of walking

Detailed Description

Locomotor training (LT) is an activity-based therapy to promote plasticity and recovery of walking. It is based on animal studies investigating walking recovery after spinal cord injury and the nervous system's control of walking. Normal walking is achieved through the interaction of multiple levels of the neural axis (cortex, brain stem, spinal cord). However, a basic rhythmic walking pattern is generated by central pattern generators (CPGs) located within the spinal cord. Investigations of central pattern generators indicate that sensory input specific to the task of walking can enhance the firing of these spinal neuronal centers. Thus, LT is an intensive walking program designed to provide sensory input to the spinal cord so that the neural output from the spinal CPGs can be maximized. In addition, LT uses a treadmill and a harness to provide partial body weight support enabling persons with injury to repetitively practice walking in a safe, enabling environment. Children enrolled in the study (after medical clearance and consent to participate) will undergo extensive testing and complete 12 weeks of locomotor training. Testing will examine the child's neurologic and functional status. Tests to examine functional status include: ASIA evaluation of sensory and motor function, gait analysis, comprehensive strength tests, and assessment of skills such as cycling, stepping, and kicking. Tests to examine the child's neurologic injury include: MRI, Transcranial Magnetic Stimulation (TMS), and reflex testing. Locomotor training will be conducted daily (5 days/ week) for a total of 60 sessions over 12 weeks. During training children will work closely with therapists, researcher, and trainers to practice walking skills on the treadmill and over-ground.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury (SCI)

Keywords

walking, walking recovery, physical therapy, locomotor training, body weight support, neuroplasticity, step, treadmill, treadmill training, locomotion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kids Step Study: Locomotor Training

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Locomotor Training

Other Intervention Name(s)

body weight supported treadmill training, activity-based therapy

Intervention Description

Task-specific practice of walking with assistance from trainers using body weight support and treadmill followed by training over ground, 5x/week, approximately 1.5 hours/day

Primary Outcome Measure Information:

Title

Recovery of walking, assessed in treadmill/ BWS environment and overground

Time Frame

pre-training, after 20, 40, and 60 sessions of locomotor training

Secondary Outcome Measure Information:

Title

Amount of daily step activity

Time Frame

during and post 60 sessions of locomotor training

Title

Walking independence, WISCI II

Time Frame

during and post 60 sessions of locomotor training

Title

Stepping assessment and kinematic analysis

Time Frame

Post 20, 40, and 60 sessions of locomotor training

Title

Analysis of locomotor tasks such as crawling, swimming, cycling

Time Frame

post 20, 40, and 60 sessions of locomotor training

Title

Self-selected and fast gait speed

Time Frame

Pre-training and after 20, 40, 60 sessions (post-LT)

Title

Spinal MRI to assess injury

Time Frame

Pre-training

Title

Spinal reflex assessment (H reflex)

Time Frame

Pre-training and post-training

Title

Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)

Time Frame

Pre-training and post-training

Title

Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion

Time Frame

Pre-training and post-training

Title

Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation

Time Frame

Pre-training and post-training

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals with SCI will include: Pre-adolescent children, ages 3-13 yrs old A diagnosis of first time, non-progressive SCI, upper motor neuron lesion, including, but not limited to, etiology from trauma, inflammation, vascular, surgical re-section due to localized tumor removal or orthopedic pathology resulting in clinical signs of lower cervical or thoracic spinal cord injury Non-ambulatory or impaired ambulation for greater than 1 yr, such that physical assistance and the use of assistive devices (i.e. walker) and/or leg braces (i.e. knee- ankle- foot orthoses (KAFOs)) are required to ambulate A SCI as defined by the American Spinal Injury Association (ASIA) Impairment Scale category B or C A medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with a training protocol Documented medical approval from the participant's personal physician verifying the participant's medical status Parent's informed consent for children Exclusion Criteria Children with SCI who - Are currently participating in a rehabilitation program or another research protocol that could interfere or influence the outcome measures of the current study Have a history of congenital SCI (e.g. Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration or syringomyelia) that may complicate the treatment and/or evaluation procedures Children who are diabetic or have implants, pacemakers, or devices which are not NMR/MRI compatible and are not suitable for the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea L Behrman, PhD, PT

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dena R Howland, PhD, OT

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16629638

Citation

Barbeau H, Nadeau S, Garneau C. Physical determinants, emerging concepts, and training approaches in gait of individuals with spinal cord injury. J Neurotrauma. 2006 Mar-Apr;23(3-4):571-85. doi: 10.1089/neu.2006.23.571.

Results Reference

background

PubMed Identifier

10025502

Citation

Barbeau H, Ladouceur M, Norman KE, Pepin A, Leroux A. Walking after spinal cord injury: evaluation, treatment, and functional recovery. Arch Phys Med Rehabil. 1999 Feb;80(2):225-35. doi: 10.1016/s0003-9993(99)90126-0.

Results Reference

background

PubMed Identifier

16305274

Citation

Behrman AL, Lawless-Dixon AR, Davis SB, Bowden MG, Nair P, Phadke C, Hannold EM, Plummer P, Harkema SJ. Locomotor training progression and outcomes after incomplete spinal cord injury. Phys Ther. 2005 Dec;85(12):1356-71.

Results Reference

background

PubMed Identifier

10869131

Citation

Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.

Results Reference

background

PubMed Identifier

15217329

Citation

Edgerton VR, Tillakaratne NJ, Bigbee AJ, de Leon RD, Roy RR. Plasticity of the spinal neural circuitry after injury. Annu Rev Neurosci. 2004;27:145-67. doi: 10.1146/annurev.neuro.27.070203.144308.

Results Reference

background

PubMed Identifier

17012645

Citation

Behrman AL, Bowden MG, Nair PM. Neuroplasticity after spinal cord injury and training: an emerging paradigm shift in rehabilitation and walking recovery. Phys Ther. 2006 Oct;86(10):1406-25. doi: 10.2522/ptj.20050212.

Results Reference

background

Learn more about this trial

Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)

We'll reach out to this number within 24 hrs