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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05122949
Other study ID # 2017/00541
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2017
Est. completion date August 22, 2018

Study information

Verified date November 2021
Source Tan Tock Seng Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 22, 2018
Est. primary completion date August 22, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
3D Printed Ankle-Foot Orthosis
3D Printed (Fused Deposition Modelling) Ankle-Foot Orthosis with Polyamide Nylon-12 material
Thermoformed Ankle-Foot Orthosis
Thermoformed Ankle-Foot Orthosis with homopolymer polypropylene

Locations

Country Name City State
Singapore Tan Tock Seng Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) scores 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. Baseline, 3 weeks follow-up and 6 weeks follow-up
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