An interventional study of Dynamic-orthosis and Traditional stroke occupational therapy training in Stroke, sponsored by National Cheng-Kung University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.
This study is a randomized controlled intervention trial. Participants are recruited from two medical centers in Taiwan and undergo a continuous 6-week intervention for post-stroke movement rehabilitation. The control group receives traditional stroke occupational therapy rehabilitation. The experimental group, in addition to traditional treatment, supplements their therapy with the use of modular 3D printed dynamic orthoses developed by the research team for home training. Both groups undergo two effectiveness follow-up assessments, one month and two months after the intervention.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →National Cheng-Kung University Hospital is the lead sponsor of 276 studies on the registry; 71 are open to participants now.
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Participants will undergo traditional occupational therapy (2-3 times per week, one hour per session, for a total of six weeks), supplemented with an additional home-based dynamic orthotic therapy program (five days per week, one hour per session, for six weeks). The style of the dynamic orthosis will be selected by the researchers based on the participants' movement performance and rehabilitation goals, and it will be adjusted or replaced as their abilities progress.
Device: Dynamic-orthosis · Other: Traditional stroke occupational therapy training
Participants will receive traditional occupational therapy (2-3 sessions per week, one hour per session, for a total of six weeks). The training program includes muscle strength training, reaching and grasping exercises, manual tone control, motor facilitation, and activities of daily living training. During the study period, participants will not wear any hand dynamic orthosis during training.
Other: Traditional stroke occupational therapy training
Engaging in motion training at home with the use of dynamic orthoses.
Traditional post-stroke movement training arranged by an occupational therapist in a medical setting.
Fugl-Meyer Assessment- Upper Extremity
The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a specialized test designed for evaluating motor function in individuals post-stroke. It employs an ordinal scale to score 33 items related to upper limb movements, with a total score of 66 points. Each item reflects movements indicative of motor function in post-stroke hemiparetic patients, covering a range from proximal to distal joints. The FMA-UE has undergone extensive testing and has been found to possess excellent psychometric properties. It is considered an effective assessment tool for upper limb motor function, particularly suitable for chronic stroke patients with moderate to severe impairments.
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Box and Block Test
The Box and Block Test (BBT) is a tool used to assess manual dexterity, known for its short assessment time, simplicity, and ease of understanding. It exhibits excellent test-retest reliability (0.96) and inter-rater reliability (0.99). The test involves counting the number of cubes a person can move within one minute, with a higher quantity indicating better functionality. The size of the cubes is 2.5cm³, and there are a total of 150 cubes. Past research suggests a Minimal Clinically Important Difference (MCID) value of 5.5 cubes for the BBT.
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Motor Activity Log
The Motor Activity Log (MAL) is a questionnaire-based assessment that evaluates the amount of use (AOU) and quality of movement (QOM) of the affected side in daily activities. The scoring for amount of use ranges from 0 (never using the affected hand in the activity) to 5 (always using the affected hand in the activity). Quality of movement is scored from 0 (unable to use the affected hand) to 5 (movement quality comparable to pre-stroke). There are a total of 28 items in the assessment, recording the average scores for both amount of use and movement quality for each item. Previous research has demonstrated good construct validity for this scale, with a Minimal Clinically Important Difference (MCID) ranging from 1.0 to 1.1 points.
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Modified Ashworth scale
The MAS (Modified Ashworth Scale) utilizes quick stretching to assess muscle tone, with testing conducted on the upper limb, specifically the hand, elbow, wrist, and fingers. For ease of statistical analysis, the scale is converted into numerical values ranging from 0 to 5, with lower scores indicating lower muscle tone.
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Upper limb joint range of motion
This study will use a goniometer to measure the upper limb joint range of motion in patients, including the shoulder, elbow, wrist, and fingers. The measurements encompass passive range of motion (PROM), active range of motion without wearing orthosis (AROM), and active-assisted range of motion with orthosis assistance (AAROM).
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Plan to share: No
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Started Jan 2024 (actual). Primary completion is estimated for Sep 2025, 20 months after the start.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 20 months is below that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
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