Cerebral Palsy Clinical Trial
Official title:
The Effects of a Powered Knee Orthosis on Gait Kinematics of Children With Knee Extension Deficiency
NCT number | NCT05330052 |
Other study ID # | H22-00239 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2022 |
Est. completion date | December 23, 2023 |
Verified date | May 2024 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Crouch gait/walking, characterized by an 'over-flexed' knee when the leg is supporting body weight, is common in children with diagnoses of cerebral palsy, spina bifida and other incomplete spinal cord injuries. The "Agilik" is a leg exoskeleton device that aims to improve how children with crouch gait walk. In this study 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 six sessions of training with the Agilik.
Status | Completed |
Enrollment | 4 |
Est. completion date | December 23, 2023 |
Est. primary completion date | December 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 19 Years |
Eligibility | Inclusion Criteria: - Age 5-19 years of age - Male or female - Able to understand and follow simple directions based on parent report and physician observation during history and physical examination - Able to provide verbal/written assent. - Less than 20 degrees of knee flexion contracture with hip extended in supine position. - Less than 10 degrees of plantar flexion contracture in neutral foot alignment. - A measured foot-thigh angle of -10 to 25 degrees in prone position. - Based on clinical observation of gait pattern, the patient walks with crouch gait. (The exact level of knee extension deficiency, or crouch, will be quantified after inclusion using gait analysis.) - Able to walk at least 10 feet without stopping with or without a walking aid. Exclusion Criteria: - Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed for short periods of time. - A history of a seizure in the past year. |
Country | Name | City | State |
---|---|---|---|
Canada | The Motion Lab, Sunny Hill Health Centre at BC Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Bionic Power |
Canada,
Conner BC, Schwartz MH, Lerner ZF. Pilot evaluation of changes in motor control after wearable robotic resistance training in children with cerebral palsy. J Biomech. 2021 Sep 20;126:110601. doi: 10.1016/j.jbiomech.2021.110601. Epub 2021 Jul 8. — View Citation
Damiano DL, Arnold AS, Steele KM, Delp SL. 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. Phys Ther. 2010 Feb;90(2):269-79. doi: 10.2522/ptj.20090062. Epub 2009 Dec 18. — View Citation
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. — View Citation
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. — View Citation
Hicks JL, Schwartz MH, Arnold AS, Delp SL. Crouched postures reduce the capacity of muscles to extend the hip and knee during the single-limb stance phase of gait. J Biomech. 2008;41(5):960-7. doi: 10.1016/j.jbiomech.2008.01.002. Epub 2008 Mar 4. — View Citation
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. — View Citation
O'Sullivan R, Horgan F, O'Brien T, French H. The natural history of crouch gait in bilateral cerebral palsy: A systematic review. Res Dev Disabil. 2018 Sep;80:84-92. doi: 10.1016/j.ridd.2018.06.013. Epub 2018 Jun 27. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial effect: Sagittal knee joint kinematics | Maximum knee extension (measured in degrees) during the stance phase of gait will be compared between barefoot gait and gait while wearing the Agilik. | day 1 | |
Primary | Training effect: Sagittal knee joint kinematics | Maximum knee extension (measured in degrees) during the stance phase of gait will be compared between barefoot gait at the start of the trial and barefoot gait after 6 weeks of weekly training sessions with the Agilik. | 6 weeks | |
Secondary | Initial effect: Sagittal knee kinetics | Sagittal knee moment profiles (measured in N.m/kg) during the stance phase of gait will be compared between barefoot gait and gait while wearing the Agilik. | day 1 | |
Secondary | Training effect: Sagittal knee kinetics | Sagittal knee moment profiles (measured in N.m/kg) during the stance phase of gait will be compared between barefoot gait at the start of the trial and barefoot gait after 6 weeks of weekly training sessions with the Agilik. | 6 weeks | |
Secondary | Initial effect: Velocity of gait | Gait velocity (measured in m/s) will be compared between barefoot gait and gait while wearing the Agilik. | day 1 | |
Secondary | Training effect: Velocity of gait | Gait velocity (measured in m/s) will be compared between barefoot gait at the start of the trial and barefoot gait after 6 weeks of weekly training sessions with the Agilik. | 6 weeks | |
Secondary | Initial effect: Step-length of gait | Step-length during gait (measured in m) will be compared between barefoot gait and gait while wearing the Agilik. | day 1 | |
Secondary | Training effect: Step-length of gait | Step-length during gait (measured in m) will be compared between barefoot gait at the start of the trial and barefoot gait after 6 weeks of weekly training sessions with the Agilik. | 6 weeks |
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