Comparison of Conventionally Manufactured AFO and Modular Customized AFO

NCT05192915 | Completed

• 1 other identifier: AFO4-0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait, Drop Foot

Outcome Measures

Primary Outcomes (1)

• Gait Profile Score (GPS)

  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.

  immediately after the intervention (gait analysis)

Secondary Outcomes (1)

• Movement Analysis Profile (MAP) and spatial-temporal parameters

  immediately after the intervention (gait analysis)

Study Arms (1)

Modular customized AFO

OTHER

Walks better at self selected speed with a modular customized AFO than with a conventional AFO.

Device: Modular customized AFO

Interventions

Modular customized AFO DEVICE

Walks better at self selected speed with a modular customized AFO than with a conventional AFO.

Modular customized AFO

Eligibility Criteria

• Age: 11 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Other neuromuscular diseases
• Surgical intervention lower extremities past 12 months to improve gait pathologies
• Inability or unwillingness to follow the procedures of the gait analysis
• in women: pregnancy

Sponsors & Collaborators

• Beat Göpfert: lead

Study Sites (1)

University of Basel

Basel, Canton of Basel-City, 4000, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 28243583 BACKGROUND

• 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.

  PMID: 19632117 BACKGROUND

• 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.

  PMID: 28698802 BACKGROUND

• 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.

  PMID: 34354172 BACKGROUND

• 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.

  PMID: 18703958 BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beat Goepfert, MEng, EMBA

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MEng, EMBA

Model Details: This study is a prospective, cross-sectional within-subjects comparison

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 14, 2022
• Study Start: February 25, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)