Comparison of Conventionally Manufactured AFO and Modular Customized AFO
NCT ID: NCT05192915
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
15 participants
INTERVENTIONAL
2022-02-25
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 \[6\]. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Modular customized AFO
Walks better at self selected speed with a modular customized AFO than with a conventional AFO.
Modular customized AFO
Walks better at self selected speed with a modular customized AFO than with a conventional AFO.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Modular customized AFO
Walks better at self selected speed with a modular customized AFO than with a conventional AFO.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
11 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beat Göpfert
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Beat Göpfert
MEng, EMBA
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beat Goepfert, MEng, EMBA
Role: PRINCIPAL_INVESTIGATOR
University of Basel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Basel
Basel, Canton of Basel-City, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AFO4-0
Identifier Type: -
Identifier Source: org_study_id