The Effects of a Powered Knee Orthosis on Gait Kinematics of Children With Knee Extension Deficiency

NCT05330052 | Completed

• 1 other identifier: H22-00239
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Spina Bifida; Spinal Cord Injuries

Keywords

biomechanics; motion capture; powered orthoses; crouch gait

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Initial effect: Sagittal knee kinetics

  day 1

• Training effect: Sagittal knee kinetics

  6 weeks

• Initial effect: Velocity of gait

  day 1

• Training effect: Velocity of gait

  6 weeks

• Initial effect: Step-length of gait

  day 1

Study Arms (1)

Agilik

EXPERIMENTAL

The participant will be provided custom knee orthoses (the Agilik) to trial in this study

Device: Agilik

Interventions

Agilik DEVICE

The Agilik is a leg orthosis device supporting the knee joint, and is intended to be worn on one or both the legs. The device is customized for single patient use. It is composed of custom-fabricated polypropylene leg shells (thigh, calf and foot components) with joint supports, actuator, sensors, cabling and a battery waist pack. The Agilik is attached to the patient using straps - two on the thigh and two on the shank. A rotational linkage connects the thigh and calf portions of the device, is placed lateral to the knee joint, and is aligned with the knee center of rotation.

Agilik

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Able to walk at least 10 feet without stopping with or without a walking aid.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Bionic Power: collaborator

Study Sites (1)

The Motion Lab, Sunny Hill Health Centre at BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (9)

• 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.

  PMID: 29960128 BACKGROUND

• 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.

  PMID: 18291404 BACKGROUND

• 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.

  PMID: 10575082 BACKGROUND

• Opheim A, Jahnsen R, Olsson E, Stanghelle JK. Walking function, pain, and fatigue in adults with cerebral palsy: a 7-year follow-up study. Dev Med Child Neurol. 2009 May;51(5):381-8. doi: 10.1111/j.1469-8749.2008.03250.x. Epub 2008 Feb 3.

  PMID: 19207296 BACKGROUND

• 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.

  PMID: 20022999 BACKGROUND

• 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.

  PMID: 8906653 BACKGROUND

• 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.

  PMID: 12835066 BACKGROUND

• 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.

  PMID: 33157884 BACKGROUND

• 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.

  PMID: 34332214 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Spinal Dysraphism; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 15, 2022
• Study Start: May 6, 2022
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)