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User Satisfaction of Customised 3D Printed Ankle-Foot Orthosis in Comparison to Thermoformed Ankle-Foot Orthosis for Patients With Neurological Conditions: A Preliminary Study

NCT ID: NCT05122949

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-03

Study Completion Date

2018-08-22

Brief Summary

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Study Design and Subject Recruitment: This was a cross-sectional study in a single centre outpatient setting at the Foot Care and Limb Design Centre, Tan Tock Seng Hospital. As this was a proof-of-concept clinical trial for the introduction of 3D printed AFOs as a patient service, only 5 subjects were recruited based on consecutive sampling.

Interventions: Thermoformed AFOs moulded over the subject's lower limb plaster model served as the control intervention. The plaster models were rectified by an orthotist with over 20 years of experience and the AFO design was determined according to the subject's clinical presentation and needs. The AFOs were manufactured from 4 - 5mm thick homopolymer polypropylene. 3D printed AFOs served as the treatment intervention. It was fabricated through 3D scanning with an Artec Eva 3D scanner (Artec 3D, Luxembourg, Luxembourg) and an adjustable Perspex glass foot plate, CAD modelling with the OrtenShape software (Proteor, Saint-Apollinaire, France), and printed using fused deposition modelling with the Fortus 450mc (Stratasys, Minnesota, United States). The 3D printed AFO is printed of Polyamide Nylon-12 material in the same thickness as the thermoformed AFO. There were no blinding procedures as both interventions were distinctly different and it is not possible to blind subjects with daily use of the AFOs.

Trial Schedule: A thermoformed and a 3D printed AFO were fitted to each subject in a single session. The QUEST survey was administered post-fitting. Subjects brought home both AFOs and were instructed to wear them during ambulation, alternating between the AFOs daily. Subjects returned for follow-up at 3 weeks and 6 weeks post-fitting for necessary adjustments and the administration of the QUEST surveys was repeated for each AFO.

Detailed Description

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Conditions

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Stroke Spinal Cord Injuries Nerve Palsy

Keywords

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3D print Digitisation Ankle-foot orthosis user satisfaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adults with neurological disorders

Group Type EXPERIMENTAL

3D Printed Ankle-Foot Orthosis

Intervention Type DEVICE

3D Printed (Fused Deposition Modelling) Ankle-Foot Orthosis with Polyamide Nylon-12 material

Thermoformed Ankle-Foot Orthosis

Intervention Type DEVICE

Thermoformed Ankle-Foot Orthosis with homopolymer polypropylene

Interventions

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3D Printed Ankle-Foot Orthosis

3D Printed (Fused Deposition Modelling) Ankle-Foot Orthosis with Polyamide Nylon-12 material

Intervention Type DEVICE

Thermoformed Ankle-Foot Orthosis

Thermoformed Ankle-Foot Orthosis with homopolymer polypropylene

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Existing patients of the centre,
* Clinical need for an AFO due to neurological disorders.

Exclusion Criteria

* Cognitive impairment
* Lower limb volume fluctuations
* Severe foot/ ankle varus or valgus deformities
* Lower limb contractures of over 10°
* Non-community ambulators
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2017/00541

Identifier Type: -

Identifier Source: org_study_id