Actively Recruiting
Development of Modular 3D-Printed Dynamic Orthoses for Hand Function Rehabilitation in Stroke Patients A Randomized Controlled Intervention Study
Led by National Cheng-Kung University Hospital · Updated on 2024-12-27
80
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
N
National Cheng-Kung University Hospital
Lead Sponsor
N
National Science and Technology Council, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the benefits of using modular 3D printed dynamic orthoses to improve upper limb function in stroke survivors. This randomized controlled trial includes participants who have had a stroke at least three months prior and aims to compare the effectiveness of these orthoses combined with traditional occupational therapy versus traditional therapy alone. The study focuses on post-stroke movement rehabilitation and hand function facilitation. Participants are divided into two groups: one receiving traditional stroke occupational therapy arranged by therapists in medical settings, and the other receiving the same traditional therapy supplemented with home training using specially designed modular 3D printed dynamic orthoses. The intervention lasts for 6 continuous weeks, during which the experimental group uses the dynamic orthoses at home as part of their motion training. Throughout the study, participants undergo several assessments including the Fugl-Meyer Assessment for upper extremity, the Box and Block Test, and the Motor Activity Log at baseline (week 0), after the 6-week intervention, and at two follow-up points one month and two months post-intervention (weeks 10 and 14). These measures help evaluate improvements in hand function and motor activity. The study carefully monitors participants' progress and outcomes over this timeline to assess the orthoses' impact alongside traditional therapy.
CONDITIONS
Official Title
Dynamic-orthosis Programs for Stroke Hand Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stroke onset at least three months ago
- Upper limb Brunnstrom stage II to IV
- Shoulder can actively flex at least 45 degrees
You will not qualify if you...
- Affected hand can grasp and release a tennis ball 10 times within 2 minutes
- Joint deformity or stiffness in the affected hand preventing use of dynamic orthosis
- Other neurological disorders affecting motor control such as neglect or Parkinson's disease
- Inability to follow therapist guidance
- Currently receiving other treatments affecting motor recovery like rTMS or BTX
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cheng Kung University
Tainan, Taiwan, 701
Actively Recruiting
Research Team
J
JERHAO CHANG
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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