The Investigator will investigate the difference in the gait pattern between 2 commercially available ankle foot orthoses (AFO): a) conventionally manufactured AFO and b) modular customized AFO using Industry 4.0 technology. Measurement method: The participants perform an instrumented gait analyses while overground walking at a self – selected speed using a conventionally manufactured AFO or a modular customized AFO.
Full Title of Study: “Comparison of Conventionally Manufactured Lower Leg Orthoses and Modular Customized Lower Leg Orthoses (AFO 4.0) in Patients With Limited Neuromuscular Foot Function During Overground Walking”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Screening
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2023
Cerebral palsy (CP) is the most common movement disorder in children [Stavsky, 2017]. It is frequently accompanied by spasticity [Baker, 2009]. The typical symptoms of spastic cerebral palsy are gait abnormalities such as equinus and drop foot that lead to severe impairments in daily life [Armand, 2016]. As these symptoms will persist in adulthood, an AFO is frequently required in this patient population. Furthermore, other neurological diseases e.g stroke [Choo, 2021], spinal cord injury, and peripheral nerve injury may require the daily use of an AFO. Ankle-foot orthoses (AFO) have been suggested to improve the dynamic efficiency of the gait. In addition, a positive effects on gait kinetics and kinematics have been reported [Figueiredo, 2008]. Recently, modular customized AFO are increasingly proposed as their response can be tuned to the patient's gait characteristics and/or functional maturity . However, the evidence on this topic is still lacking and modular customized AFO are not yet established in clinical routine. The aim of this study is to assess gait parameters with an instrumented gait analysis of the modular customized AFO compared to conventional, untuned AFO in a group of adolescents and a group of adults using for there daily activity an AFO, while over ground walking at self selected speed over a distance of about 10 m.
- Device: AFO4-0
- Comparison of conventional AFO and the modular customized AFO while overground walking at a self selected speed.
Arms, Groups and Cohorts
- Other: Modular customized AFO
- Walks better with a modular customized AFO than with a conventional AFO.
Clinical Trial Outcome Measures
- Gait Profile Score (GPS)
- Time Frame: immediately after the intervention (gait analysis)
- The primary outcome measure is the gait profile score (GPS), which is an overall score calculated from all kinematic parameters (joint rotation angles) of the affected leg and expressed as the deviation from the normal gait cycle in degrees. The outcome of the GPS will be compared between the conventional AFO, and modular customized AFO for each participant and for each group.
- Movement Analysis Profile (MAP) and spatial-temporal parameters
- Time Frame: immediately after the intervention (gait analysis)
- Secondary outcomes are the Movement analysis profile (MAP) and spatial-temporal parameters, both calculated from kinematic parameters and expressed as the deviation from the normal gait cycle in degrees. The MAP consists of individual scores for each joint rotation angle (pelvic tilt, pelvic obliquity, pelvic rotation, hip flexion/extension, hip abduction/adduction, hip rotation, knee flexion/extension, ankle dorsiﬂexion/extension and foot progression) of the affected leg . Spatial-temporal parameters are walking speed (m/s), cadence (steps/min x 100) and stride length (m) of the affected leg. The above-mentioned parameters will be compared between the conventional AFO, and modular customized AFO for each participant and for each group.
Participating in This Clinical Trial
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Patients (11-18 yrs.), who need a new orthosis (visit to an orthopedic technician) – Patients (18-65 yrs.), who need a new orthosis (visit to an orthopedic technician) – Informed Consent provided as documented by signature – Confirmed diagnosis of cerebral palsy – Confirmed diagnosis of spastic equinus and/ or drop foot, – Gait pathologies treated with conventional AFO – Gross Motor Function Classification System (GMFCS) level I or II Exclusion Criteria:
- Other neuromuscular diseases – Surgical intervention lower extremities past 12 months to improve gait pathologies – Injections of Botulinum toxin 6 months prior to study inclusion – Inability or unwillingness to follow the procedures of the gait analysis – in women: pregnancy
Gender Eligibility: All
Minimum Age: 11 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Beat Göpfert
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Beat Göpfert, MEng, EMBA – University of Basel
- Overall Official(s)
- Beat Goepfert, MEng, EMBA, Principal Investigator, University of Basel
- Overall Contact(s)
- Beat Goepfert, MEng, EMBA, +41 61 207 54 28, Beat.email@example.com
Stavsky M, Mor O, Mastrolia SA, Greenbaum S, Than NG, Erez O. Cerebral Palsy-Trends in Epidemiology and Recent Development in Prenatal Mechanisms of Disease, Treatment, and Prevention. Front Pediatr. 2017 Feb 13;5:21. doi: 10.3389/fped.2017.00021. eCollection 2017. Review.
Baker R, McGinley JL, Schwartz MH, Beynon S, Rozumalski A, Graham HK, Tirosh O. The gait profile score and movement analysis profile. Gait Posture. 2009 Oct;30(3):265-9. doi: 10.1016/j.gaitpost.2009.05.020. Epub 2009 Jul 24.
Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
Choo YJ, Chang MC. Effectiveness of an ankle-foot orthosis on walking in patients with stroke: a systematic review and meta-analysis. Sci Rep. 2021 Aug 5;11(1):15879. doi: 10.1038/s41598-021-95449-x.
Figueiredo EM, Ferreira GB, Maia Moreira RC, Kirkwood RN, Fetters L. Efficacy of ankle-foot orthoses on gait of children with cerebral palsy: systematic review of literature. Pediatr Phys Ther. 2008 Fall;20(3):207-23. doi: 10.1097/PEP.0b013e318181fb34. Review.
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