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

NCT05122949 | Completed

• 1 other identifier: 2017/00541
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spinal Cord Injuries; Nerve Palsy

Keywords

3D print; Digitisation; Ankle-foot orthosis; user satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adults with neurological disorders

EXPERIMENTAL

Device: 3D Printed Ankle-Foot Orthosis; Device: Thermoformed Ankle-Foot Orthosis

Interventions

3D Printed Ankle-Foot Orthosis DEVICE

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

Adults with neurological disorders

Thermoformed Ankle-Foot Orthosis DEVICE

Thermoformed Ankle-Foot Orthosis with homopolymer polypropylene

Adults with neurological disorders

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 17, 2021
• Study Start: November 3, 2017
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

SG (1)