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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Ankara, Tyrkiet (Türkiye)
- Ankara University, Faculty of Health Sciences
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MCP Joint Stabilization
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
QUEST 2.0 Total Satisfaction Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- AU-RMF-2023-620
Plan for individuelle deltagerdata (IPD)
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