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 (Other)
Overall Status
Completed
CT.gov ID
NCT05122949
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
9.6
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 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 DiseaseIntervention/TreatmentPhase
  • Device: 3D Printed Ankle-Foot Orthosis
  • Device: Thermoformed Ankle-Foot Orthosis
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Nov 3, 2017
Actual Primary Completion Date :
Aug 22, 2018
Actual Study Completion Date :
Aug 22, 2018

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Change in Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) scores [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Tan Tock Seng HospitalSingaporeSingapore

Sponsors and Collaborators

  • Tan Tock Seng Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT05122949
Other Study ID Numbers:
  • 2017/00541
First Posted:
Nov 17, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tan Tock Seng Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021