Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID06271187

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

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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