3D Versus Low-Temperature Thermoplastic Relative Motion Orthosis: MP Joint Stabilization
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.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Тип исследования
Тип исследования
Регистрация (Действительный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Ankara, Турция (Туркие)
- Ankara University, Faculty of Health Sciences
-
-
Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Healthy adult volunteers.
- No orthopedic or neurological impairments involving the upper extremities.
- No reported history of systemic illness or previous surgical interventions.
- Provision of written informed consent before enrollment.
Exclusion Criteria:
- Current upper extremity pain.
- Joint deformities.
- Skin integrity problems.
- Any condition that could interfere with RMF orthosis application or wearing.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
|---|---|
|
Экспериментальный: TPU-PLA-LTT
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. |
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. |
|
Экспериментальный: TPU-LTT-PLA
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. |
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. |
|
Экспериментальный: PLA-TPU-LTT
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 |
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. |
|
Экспериментальный: PLA-LTT-TPU
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. |
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. |
|
Экспериментальный: LTT-TPU-PLA
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. |
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. |
|
Экспериментальный: LTT-PLA-TPU
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 |
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. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
MCP Joint Stabilization
Временное ограничение: At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
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. |
At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
QUEST 2.0 Total Satisfaction Score
Временное ограничение: At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
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. |
At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
|
QUEST 2.0 Device Satisfaction Score
Временное ограничение: At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
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. |
At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
|
QUEST 2.0 Service Satisfaction Score
Временное ограничение: At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
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. |
At the end of each 2-day orthosis wearing period (3 assessments per participant).
|
Соавторы и исследователи
Спонсор
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
Первичное завершение (Действительный)
Первичное завершение
Завершение исследования (Действительный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- AU-RMF-2023-620
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .