Clinical trial NCT05192915: Comparison of Conventionally Manufactured AFO and Modular Customized AFO
Official title: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Drop Foot
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 15
Sex: ALL
Minimum age (years): 11
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective, cross-sectional within-subjects comparison
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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 \[6\]. 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Gait Profile Score (GPS)
timeFrame: immediately after the intervention (gait analysis)
Secondary outcomes:
measure: Movement Analysis Profile (MAP) and spatial-temporal parameters
timeFrame: immediately after the intervention (gait analysis)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: BS
Study officials:
affiliation: University of Basel
name: Beat Goepfert, MEng, EMBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.