Evaluating Functional Outcomes of 3D-Printed Splints in Post-Stroke Upper Limb Recovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Saud University
About this trial
This study aims to evaluate the upper limb motor recovery using a 3D-printed dynamic orthosis compared to a conventional one as part of a rehabilitation program in individuals with chronic stroke.
The main question it seeks to answer:
Which type of dynamic splint (3D-printed or traditional), combined with the task-oriented therapy program, leads to greater improvement in affected upper-limb function, patient satisfaction, and usability in stroke patients? Researchers will compare these two types of dynamic splints.
Participants will:
Receive 20 sessions of task-oriented therapy combined with either a 3D-printed dynamic splint or a traditional dynamic splint.
Visit the clinic five times a week for a period of four weeks. Undergo assessments before and after the 4-week program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years old.
Chronic stroke
Upper limb hemiparalysis
Ability to understand and follow orders and able to provide informed consent (Mini-Mental State Exam (MMSE) > 24)
Disqualifiers
Had deficits in language or cognitive impairments that were likely to interfere with their cooperation in the study
Deformity or presented with severe upper-limb contractures
Inability to commit to the time requirement of the protocol.
Unilateral neglect
Trial design
Design model
Parallel
Treatments tested in this trial
3D Printed splint
DevicePatients undergo 60-minute therapy sessions 5 times per week for 4 weeks, including stretching and task-oriented training. Splint Protocol: A 3D-printed dynamic splint is worn during the 60-minute clinic session, plus an additional 5 hours daily on training days and 6 hours daily on non-training days
conventional splint
DevicePatients undergo 60-minute therapy sessions 5 times per week for 4 weeks, including stretching and task-oriented training. Splint Protocol: A conventional dynamic splint is worn during the 60-minute clinic session, plus an additional 5 hours daily on training days and 6 hours daily on non-training days
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: 3D-Printed Dynamic Splint GroupExperimental treatment 1 intervention
Group B: Dynamic Splint GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wolf Motor Function Test (WMFT)
The WMFT is a standardized assessment used to measure upper extremity motor ability through the performance of 17 tasks that include both functional and strength components. Rated using the 6-point scale ranging from 0 (no attempt) to 5 (normal movement). The total performance time and quality of movement are recorded, with lower scores indicating lower levels of functioning.
Time frame
at baseline and after intervention (4 weeks)2
Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
The FMA-UE is a comprehensive quantitative measure designed to evaluate motor function, coordination, and reflex activity of the affected upper limb following stroke. It uses a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 points for the upper extremity. It is considered the gold standard for assessment of upper limb motor recovery.
Time frame
at baseline and after intervention (4 weeks)3
Box and Block Test (BBT)
The BBT is a validated measure of gross manual dexterity that evaluates how many 1-inch wooden blocks a participant can transfer from one compartment to another within 60 seconds using one hand. The apparatus consists of a wooden box divided into two equal sections containing 150 small cubes. The test begins with the unaffected upper limb to allow practice and establish a baseline performance. Participants are then instructed to move as many blocks as possible, one at a time, over the partition within the time limit. The score is defined as the total number of blocks successfully transferred within 60 seconds.
Time frame
at baseline and after intervention (4 weeks)Secondary outcomes
1
Motor Activity Log (MAL)
MAL is a validated, self-reported questionnaire that assesses the real-world use of the affected upper limb during activities of daily living. It consists of two subscales: the Amount of Use (AOU) and the Quality of Movement (QOM). Each subscale contains 30 items rated on a 6-point Likert scale. For the AOU subscale, participants rate how frequently they used their affected arm, from 0 ("did not use my weaker arm") to 5 ("used my weaker arm as often as before the stroke"). For the QOM subscale, participants rate how well the affected limb assisted in the task, from 0 ("my weaker arm was not used at all for that activity") to 5 ("the ability to use my weaker arm was as good as before the stroke").
Time frame
at baseline and after intervention (4 weeks)2
Arabic Version of Stroke Impact Scale (SIS-16)
The SIS-16 is a self-report tool designed to evaluate health-related quality of life among stroke survivors. It includes 16 items covering mobility, self-care, and hand function, rated on a 5-point Likert scale (1 = unable to do, 5 = not difficult at all). Higher scores represent a better level of health-related quality of life status for stroke patients.
Time frame
at baseline and after intervention (4 weeks)3
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
QUEST 2.0 assesses user satisfaction with assistive devices and related services through 12 items divided into two subscales: device satisfaction and service satisfaction. Each item is rated on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied)
Time frame
Each session (5 times per week)Sponsors and contacts
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Source ClinicalTrials.gov
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