User Satisfaction of Customised 3D Printed Ankle-Foot Orthosis in Comparison to Thermoformed Ankle-Foot Orthosis for Patients With Neurological Conditions: A Preliminary Study
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|ClinicalTrials.gov Identifier: NCT05122949|
Recruitment Status : Completed
First Posted : November 17, 2021
Last Update Posted : November 17, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Spinal Cord Injuries Nerve Palsy||Device: 3D Printed Ankle-Foot Orthosis Device: Thermoformed Ankle-Foot Orthosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||User Satisfaction of Customised 3D Printed Ankle-Foot Orthosis in Comparison to Thermoformed Ankle-Foot Orthosis for Patients With Neurological Conditions: A Preliminary Study|
|Actual Study Start Date :||November 3, 2017|
|Actual Primary Completion Date :||August 22, 2018|
|Actual Study Completion Date :||August 22, 2018|
|Experimental: Adults with neurological disorders||
Device: 3D Printed Ankle-Foot Orthosis
3D Printed (Fused Deposition Modelling) Ankle-Foot Orthosis with Polyamide Nylon-12 material
Device: Thermoformed Ankle-Foot Orthosis
Thermoformed Ankle-Foot Orthosis with homopolymer polypropylene
- Change in Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) scores [ Time Frame: Baseline, 3 weeks follow-up and 6 weeks follow-up ]QUEST 2.0 comprises of 12 items, with 8 items related to user satisfaction with assistive devices and 4 service-related items. Responses for the QUEST items were based on a 5-level response scale, with 1 - Not satisfied at all; 2 - Not very satisfied; 3 - More or less satisfied; 4 - Quite satisfied; and 5 - Very satisfied.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Existing patients of the centre,
- Clinical need for an AFO due to neurological disorders.
- Cognitive impairment
- Lower limb volume fluctuations
- Severe foot/ ankle varus or valgus deformities
- Lower limb contractures of over 10°
- Non-community ambulators
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05122949
|Tan Tock Seng Hospital|
|Responsible Party:||Tan Tock Seng Hospital|
|Other Study ID Numbers:||
|First Posted:||November 17, 2021 Key Record Dates|
|Last Update Posted:||November 17, 2021|
|Last Verified:||November 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries