This trial will study the effects of the Agilik, a leg exoskeleton device, on children with crouch gait. Crouch gait is characterized by an 'over-flexed' knee when the leg is supporting body weight, and is common in children with diagnoses of cerebral palsy, spina bifida and other incomplete spinal cord injuries. The investigators will quantify the improvement that the Agilik facilitates in children with crouch gait in two ways: 1) the difference the Agilik makes when the participants start using it, and 2) any 'training effects' that can be seen in barefoot walking after
- Spina Bifida
- Cerebral Palsy
- Spinal Cord Injury
2 Primary · 6 Secondary · Reporting Duration: 6 weeks
Awards & Highlights
1 Treatment Group
1 of 1
5 Total Participants · 1 Treatment Group
Primary Treatment: Agilik · No Placebo Group · N/A
Who is running the clinical trial?
Age 5 - 19 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Waters, Robert L., and Sara Mulroy. 1999. “The Energy Expenditure of Normal and Pathologic Gait”. Gait & Posture. Elsevier BV. doi:10.1016/s0966-6362(99)00009-0.
- Hicks, Jennifer L., Michael H. Schwartz, Allison S. Arnold, and Scott L. Delp. 2008. “Crouched Postures Reduce the Capacity of Muscles to Extend the Hip and Knee During the Single-limb Stance Phase of Gait”. Journal of Biomechanics. Elsevier BV. doi:10.1016/j.jbiomech.2008.01.002.
- Kang, J., D. Martelli, V. Vashista, I. Martinez-Hernandez, H. Kim, and S. K. Agrawal. 2017. “Robot-driven Downward Pelvic Pull to Improve Crouch Gait in Children with Cerebral Palsy”. Science Robotics. American Association for the Advancement of Science (AAAS). doi:10.1126/scirobotics.aan2634.
- O’Sullivan, Rory, Frances Horgan, Tim O’Brien, and Helen French. 2018. “The Natural History of Crouch Gait in Bilateral Cerebral Palsy: A Systematic Review”. Research in Developmental Disabilities. Elsevier BV. doi:10.1016/j.ridd.2018.06.013.
- OPHEIM, ARVE, REIDUN JAHNSEN, ELISABETH OLSSON, and JOHAN K STANGHELLE. 2009. “Walking Function, Pain, and Fatigue in Adults with Cerebral Palsy: A 7-year Follow-up Study”. Developmental Medicine & Child Neurology. Wiley. doi:10.1111/j.1469-8749.2008.03250.x.
- Damiano, Diane L., Allison S. Arnold, Katherine M. Steele, and Scott L. Delp. 2010. “Can Strength Training Predictably Improve Gait Kinematics? A Pilot Study on the Effects of Hip and Knee Extensor Strengthening on Lower-extremity Alignment in Cerebral Palsy”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20090062.
- Duffy, C. M., A. E. Hill, A. P. Cosgrove, I. S. Corry, R. A. B. Mollan, and H. K. Graham. 1996. “Three-dimensional Gait Analysis in Spina Bifida”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004694-199611000-00016.
- Greene, Peter J, and Malcolm H Granat. 2003. “A Knee and Ankle Flexing Hybrid Orthosis for Paraplegic Ambulation”. Medical Engineering & Physics. Elsevier BV. doi:10.1016/s1350-4533(03)00072-9.
- Conner, Benjamin C., Michael H. Schwartz, and Zachary F. Lerner. 2021. “Pilot Evaluation of Changes in Motor Control After Wearable Robotic Resistance Training in Children with Cerebral Palsy”. Journal of Biomechanics. Elsevier BV. doi:10.1016/j.jbiomech.2021.110601.
- Waters RL, Mulroy S. The energy expenditure of normal and pathologic gait. Gait Posture. 1999 Jul;9(3):207-31. doi: 10.1016/s0966-6362(99)00009-0.
- Greene PJ, Granat MH. A knee and ankle flexing hybrid orthosis for paraplegic ambulation. Med Eng Phys. 2003 Sep;25(7):539-45. doi: 10.1016/s1350-4533(03)00072-9.
- Duffy CM, Hill AE, Cosgrove AP, Corry IS, Mollan RA, Graham HK. Three-dimensional gait analysis in spina bifida. J Pediatr Orthop. 1996 Nov-Dec;16(6):786-91. doi: 10.1097/00004694-199611000-00016.
- Kang J, Martelli D, Vashista V, Martinez-Hernandez I, Kim H, Agrawal SK. Robot-driven downward pelvic pull to improve crouch gait in children with cerebral palsy. Sci Robot. 2017 Jul 26;2(8):eaan2634. doi: 10.1126/scirobotics.aan2634. Epub 2017 Jul 26.
- Timothy Bhatnagar 2022. "The Effects of a Powered Knee Orthosis on Gait Kinematics of Children With Knee Extension Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05330052.
Frequently Asked Questions
How many individuals are engaged in this experiment?
"Affirmative. According to the data shared on clinicaltrials.gov, this medical study is presently seeking participants who first posted on May 6th 2022 and last edited June 16th 2022. The researchers are searching for 5 patients from a single site." - Anonymous Online Contributor
Are there any open slots for participation in this experiment?
"Affirmative, the available information from clinicaltrials.gov affirms that this investigation is presently seeking individuals to take part in it. The trial was first posted on May 6th 2022 and its details were last revised on June 16th of the same year. Five participants are required for this study and recruitment is only occurring at one site." - Anonymous Online Contributor
Is this clinical experiment accessible to those aged 25 or above?
"This study only includes children aged 5 to 19 years old." - Anonymous Online Contributor
What aims is this investigation attempting to accomplish?
"The primary evaluation metric for this 6 week trial is the initial effect of sagittal knee joint kinematics. Secondary outcomes include training-induced changes to sagittal knee kinetics, step length, and gait velocity which will be assessed post intervention with Agilik weekly sessions." - Anonymous Online Contributor
What types of individuals are ideal candidates for this research experiment?
"This clinical trial is selecting 5 minors between the ages of 5 and 19 with spinal cord injuries to participate. Candidates must meet certain criteria such as: knee flexion contracture less than 20 degrees in a supine position, gender-agnostic, able to understand basic commands based on parental report or physician assessment during physical examination, plantar flexion contracture below 10 degrees while neutral foot alignment is achieved, measured foot-thigh angle from -10 to 25 degrees when prone, display crouch gait upon observation by medical personnel (level of deficiency quantified post inclusion via gait analysis), mobility enough for them to walk at least" - Anonymous Online Contributor