Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05122949
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-10-20
Brief 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
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjects 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 subjects 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
Interventions Thermoformed AFOs moulded over the subjects 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 subjects 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None