Spinal Cord Injury (SCI)NCT00488280
Restoring Walking in Non-ambulatory Children With Severe Chronic Spinal Cord Injury (SCI) (Kids STEP Study)
An observational study of Spinal Cord Injury (SCI), run by University of Florida at 1 site in United States.
Trial summary
The Kids STEP Study aims to 1. Determine if walking can be restored in children with incomplete SCI and little to no leg movement 2. Identify the neural pathways that permit recovery of walking Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Spinal Cord Injury (SCI)
- What is being tested?
- Locomotor Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with SCI for whom walking recovery is unlikely
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)
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
Read the 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.
- Conditions
- Spinal Cord Injury (SCI)
- Being tested
- Locomotor Training
- Keywords
- walking, walking recovery, physical therapy, locomotor training, body weight support, neuroplasticity, step, treadmill, treadmill training, locomotion
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotor TrainingBehavioural
Also called body weight supported treadmill training, activity-based therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Kids Step Study: Locomotor Training | 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. Receives: Behavioral: Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of walking, assessed in treadmill/ BWS environment and overground
Measured: pre-training, after 20, 40, and 60 sessions of locomotor training
Secondary outcomes (10)
Amount of daily step activity
Measured: during and post 60 sessions of locomotor training
Walking independence, WISCI II
Measured: during and post 60 sessions of locomotor training
Stepping assessment and kinematic analysis
Measured: Post 20, 40, and 60 sessions of locomotor training
Analysis of locomotor tasks such as crawling, swimming, cycling
Measured: post 20, 40, and 60 sessions of locomotor training
Self-selected and fast gait speed
Measured: Pre-training and after 20, 40, 60 sessions (post-LT)
Spinal MRI to assess injury
Measured: Pre-training
Spinal reflex assessment (H reflex)
Measured: Pre-training and post-training
Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)
Measured: Pre-training and post-training
Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion
Measured: Pre-training and post-training
Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation
Measured: Pre-training and post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Brooks Rehabilitation, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Andrea L Behrman, PhD, PT, Principal investigator, University of FloridaDena R Howland, PhD, OT, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488280
- Sponsor's protocol ID
- 313-2006
- Status last verified
- Nov 2024
- First submitted
- 19 Jun 2007
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16629638Barbeau 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.
PubMed 10025502Behrman 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.
PubMed 16305274Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
PubMed 10869131Edgerton 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.
PubMed 15217329Behrman 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.
PubMed 17012645Howland DR, Trimble SA, Fox EJ, Tester NJ, Spiess MR, Senesac CR, Kleim JA, Spierre LZ, Rose DK, Johns JS, Ugiliweneza B, Reier PJ, Behrman AL. Recovery of walking in nonambulatory children with chronic spinal cord injuries: Case series. J Neurosci Res. 2023 Jun;101(6):826-842. doi: 10.1002/jnr.25162. Epub 2023 Jan 23.
PubMed 36690607
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Walking in Non-ambulatory Children With Severe Chronic SCI (Kids STEP Study)
- ClinicalTrials.gov ID
- NCT00488280
- Acronym / sponsor ID
- 313-2006
- Conditions
- Spinal Cord Injury (SCI)
- Keywords
- walking, walking recovery, physical therapy, locomotor training, body weight support, neuroplasticity, step, treadmill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Brooks Rehabilitation, Baylor College of Medicine
- Study start
- Feb 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kids Step Study: Locomotor Training | – | Behavioral: Locomotor TrainingAll 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. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with SCI for whom walking recovery is unlikely
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locomotor TrainingAlso: body weight supported treadmill training, activity-based therapyTask-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 | Behavioural | Kids Step Study: Locomotor Training |
Primary outcome
Recovery of walking, assessed in treadmill/ BWS environment and overground
Time frame: pre-training, after 20, 40, and 60 sessions of locomotor training
10 secondary outcomes
Amount of daily step activity
Time frame: during and post 60 sessions of locomotor training
Walking independence, WISCI II
Time frame: during and post 60 sessions of locomotor training
Stepping assessment and kinematic analysis
Time frame: Post 20, 40, and 60 sessions of locomotor training
Analysis of locomotor tasks such as crawling, swimming, cycling
Time frame: post 20, 40, and 60 sessions of locomotor training
Self-selected and fast gait speed
Time frame: Pre-training and after 20, 40, 60 sessions (post-LT)
Spinal MRI to assess injury
Time frame: Pre-training
Spinal reflex assessment (H reflex)
Time frame: Pre-training and post-training
Correlation of locomotion recovery and isolated voluntary leg movement (ASIA motor score)
Time frame: Pre-training and post-training
Correlation and assessment of reticulospinal tract (Acoustic startle reflex)with recovery of locomotion
Time frame: Pre-training and post-training
Correlation and assessment of corticospinal tract integrity via transcranial magnetic stimulation
Time frame: Pre-training and post-training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 16629638Barbeau 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.
- Background: PubMed 10025502Barbeau 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.
- Background: PubMed 16305274Behrman 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.
- Background: PubMed 10869131Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
- Background: PubMed 15217329Edgerton 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.
- Background: PubMed 17012645Behrman 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.
- Derived from this study: PubMed 36690607Howland DR, Trimble SA, Fox EJ, Tester NJ, Spiess MR, Senesac CR, Kleim JA, Spierre LZ, Rose DK, Johns JS, Ugiliweneza B, Reier PJ, Behrman AL. Recovery of walking in nonambulatory children with chronic spinal cord injuries: Case series. J Neurosci Res. 2023 Jun;101(6):826-842. doi: 10.1002/jnr.25162. Epub 2023 Jan 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea L Behrman, PhD, PT principal investigator
University of Florida
Dena R Howland, PhD, OT principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury (SCI), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of walking, assessed in treadmill/ BWS environment and overground (time frame: pre-training, after 20, 40, and 60 sessions of locomotor training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488280, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.