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Gait, Drop FootAFO4-0NCT05192915

Comparison of Conventionally Manufactured AFO and Modular Customized AFO

A study testing Modular customized AFO in people with Gait, Drop Foot, run by Beat Göpfert at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 65 years
Conditions the study is for
Gait, Drop Foot
What is being tested?
Modular customized AFO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSwitzerland
Study dates
25 Feb 2022to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University of Basel

    Basel, Canton of Basel-City, 4000

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Gait, Drop Foot
Being tested
Modular customized AFO
Medical subject headings
Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modular customized AFODevice

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

Study groups in NCT05192915
Study groupRoleWhat they receive
Modular customized AFOOtherWalks better at self selected speed with a modular customized AFO than with a conventional AFO.
Receives: Device: Modular customized AFO

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after the intervention (gait analysis)

Secondary outcomes (1)

  1. Movement Analysis Profile (MAP) and spatial-temporal parameters

    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 [2]. 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.

    Measured: immediately after the intervention (gait analysis)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start25 Feb 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a prospective, cross-sectional within-subjects comparison
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05192915
Sponsor's protocol ID
AFO4-0
Acronym
AFO4-0
Status last verified
Nov 2022
First submitted
13 Dec 2021
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28243583

  • 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.

    PubMed 19632117

  • 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.

    PubMed 28698802

  • 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.

    PubMed 34354172

  • 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.

    PubMed 18703958

Questions about this trial

What is this clinical trial studying?

A study testing Modular customized AFO in people with Gait, Drop Foot, run by Beat Göpfert at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait Profile Score (GPS) (time frame: immediately after the intervention (gait analysis)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05192915, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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