An interventional study of 3D-Printed TPU Relative Motion Flexion Orthosis and 3D-Printed PLA Relative Motion Flexion Orthosis in Relative Motion Flexion Orthosis Evaluation, sponsored by Enver Guven. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Enver Guven · Not applicable, Interventional, and Other
Relative motion flexion (RMF) orthoses are used in hand rehabilitation to position finger joints in a controlled degree of flexion. These orthoses are traditionally made from low-temperature thermoplastic materials. Three-dimensional (3D) printing offers an alternative method of producing individually designed orthoses using different filament materials.
The purpose of this study was to compare finger joint stabilization and user satisfaction among RMF orthoses made from two 3D-printing materials, thermoplastic polyurethane (TPU) and polylactic acid (PLA), and a conventional low-temperature thermoplastic (LTT) material.
The study included 30 healthy adult volunteers. Each participant used all three types of RMF orthoses for two consecutive days per orthosis, with the order of application randomly determined. The orthoses were designed to position the metacarpophalangeal (MCP) joint at 30 degrees of flexion.
Joint positioning was evaluated using a goniometer, and user satisfaction was assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).
The study aimed to provide comparative information about orthosis materials and fabrication methods that may help guide future orthotic applications in hand rehabilitation.
Enver Guven is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received three RMF orthoses in the following order: 3D-printed TPU, 3D-printed PLA, and conventional LTT. Each orthosis was worn for two consecutive days.
Device: 3D-Printed TPU Relative Motion Flexion Orthosis · Device: 3D-Printed PLA Relative Motion Flexion Orthosis · Device: Low-Temperature Thermoplastic Relative Motion Flexion Orthosis
Participants received three RMF orthoses in the following order: 3D-printed TPU, conventional LTT, and 3D-printed PLA. Each orthosis was worn for two consecutive days.
Device: 3D-Printed TPU Relative Motion Flexion Orthosis · Device: 3D-Printed PLA Relative Motion Flexion Orthosis · Device: Low-Temperature Thermoplastic Relative Motion Flexion Orthosis
Participants received three RMF orthoses in the following order: 3D-printed PLA, 3D-printed TPU, and conventional LTT. Each orthosis was worn for two consecutive days. Açıklamayı kopyala
Device: 3D-Printed TPU Relative Motion Flexion Orthosis · Device: 3D-Printed PLA Relative Motion Flexion Orthosis · Device: Low-Temperature Thermoplastic Relative Motion Flexion Orthosis
Participants received three RMF orthoses in the following order: 3D-printed PLA, conventional LTT, and 3D-printed TPU. Each orthosis was worn for two consecutive days.
Device: 3D-Printed TPU Relative Motion Flexion Orthosis · Device: 3D-Printed PLA Relative Motion Flexion Orthosis · Device: Low-Temperature Thermoplastic Relative Motion Flexion Orthosis
Participants received three RMF orthoses in the following order: conventional LTT, 3D-printed TPU, and 3D-printed PLA. Each orthosis was worn for two consecutive days.
Device: 3D-Printed TPU Relative Motion Flexion Orthosis · Device: 3D-Printed PLA Relative Motion Flexion Orthosis · Device: Low-Temperature Thermoplastic Relative Motion Flexion Orthosis
Participants received three RMF orthoses in the following order: conventional LTT, 3D-printed PLA, and 3D-printed TPU. Each orthosis was worn for two consecutive days. Açıklamayı kopyala
Device: 3D-Printed TPU Relative Motion Flexion Orthosis · Device: 3D-Printed PLA Relative Motion Flexion Orthosis · Device: Low-Temperature Thermoplastic Relative Motion Flexion Orthosis
A custom relative motion flexion orthosis fabricated using thermoplastic polyurethane (TPU) filament. Individual hand geometry was obtained by 3D scanning, and the orthosis was digitally designed using Meshmixer software and manufactured using a Creality CR-10 Max 3D printer. The orthosis positioned the third metacarpophalangeal joint at 30 degrees of flexion and was worn for two consecutive days. Açıklamayı kopyala
A custom relative motion flexion orthosis fabricated using polylactic acid (PLA) filament. Individual hand geometry was obtained by 3D scanning, and the orthosis was digitally designed using Meshmixer software and manufactured using a Creality CR-10 Max 3D printer. The orthosis positioned the third metacarpophalangeal joint at 30 degrees of flexion and was worn for two consecutive days.
A conventional relative motion flexion orthosis fabricated using Orficast More low-temperature thermoplastic material (Orfit Industries, Belgium). The orthosis was manually molded directly on the participant's hand, positioning the third metacarpophalangeal joint at 30 degrees of flexion, verified using a goniometer. The orthosis was worn for two consecutive days.
MCP Joint Stabilization
The metacarpophalangeal (MCP) joint angle of the third digit of the dominant hand was measured in degrees using a goniometer after each orthosis wearing period. All orthoses were designed to maintain the MCP joint at 30 degrees of flexion. The measured joint angles were compared among three relative motion flexion (RMF) orthoses fabricated from 3D-printed thermoplastic polyurethane (TPU), 3D-printed polylactic acid (PLA), and conventional low-temperature thermoplastic (LTT). Values closer to 30 degrees indicated more accurate maintenance of the target joint position.
Time frame: At the end of each 2-day orthosis wearing period (3 assessments per participant).
QUEST 2.0 Total Satisfaction Score
Overall user satisfaction was assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). The questionnaire includes 12 items covering device-related satisfaction (8 items) and service-related satisfaction (4 items). Each item is rated on a 5-point Likert scale, with higher scores indicating greater satisfaction. Total satisfaction scores were compared across TPU, PLA, and LTT orthoses.
Time frame: At the end of each 2-day orthosis wearing period (3 assessments per participant).
QUEST 2.0 Device Satisfaction Score
Device-related satisfaction was assessed using the eight device items of the QUEST 2.0 questionnaire: dimensions, weight, adjustability, safety, durability, ease of use, comfort, and effectiveness. Each item is rated on a 5-point Likert scale, with higher scores indicating greater satisfaction. Device satisfaction scores were compared among TPU, PLA, and LTT orthoses.
Time frame: At the end of each 2-day orthosis wearing period (3 assessments per participant).
QUEST 2.0 Service Satisfaction Score
Service-related satisfaction was assessed using the four service items of the QUEST 2.0 questionnaire, covering maintenance, repair, professional services, and follow-up. Each item is rated on a 5-point Likert scale, with higher scores indicating greater satisfaction. Service satisfaction scores were compared among TPU, PLA, and LTT orthoses.
Time frame: At the end of each 2-day orthosis wearing period (3 assessments per participant).
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2024 to primary completion in Feb 2025, 8 months.
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