Dynamic-orthosis Programs for Stroke Hand Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dynamic-orthosis, Traditional stroke occupational therapy training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke
Overview
This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.
Detailed description
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.
Interventions
- Device Dynamic-orthosis
Engaging in motion training at home with the use of dynamic orthoses. - Other Traditional stroke occupational therapy training
Traditional post-stroke movement training arranged by an occupational therapist in a medical setting.
Primary outcome measures
- Fugl-Meyer Assessment- Upper Extremity [Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）]
- Box and Block Test [Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）]
- Motor Activity Log [Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）]
Secondary outcome measures (2)
- Modified Ashworth scale [Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）]
- Upper limb joint range of motion [Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）]
Eligibility criteria
Inclusion criteria
- Onset of stroke at least three months ago;
- Upper limb Brunnstrom stage II\~IV;
- Shoulder can actively flex at least 45 degrees.
Exclusion criteria
- Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;
- Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis;
- Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.;
- Inability to follow therapist guidance;
- Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Cheng Kung University — Tainan
Identifiers
NCT: NCT06271187 · A-ER-110-507