Dynamic-orthosis Programs for Stroke Hand Function

Last updated: December 23, 2024
Sponsor: National Cheng-Kung University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Dynamic-orthosis

Traditional stroke occupational therapy training

Clinical Study ID

NCT06271187
A-ER-110-507
  • Ages 20-80
  • All Genders

Study Summary

This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Onset of stroke at least three months ago;

  2. Upper limb Brunnstrom stage II~IV;

  3. Shoulder can actively flex at least 45 degrees.

Exclusion

Exclusion criteria:

  1. Affected hand has regained autonomous grasping function, able to grasp and release atennis ball 10 times within 2 minutes;

  2. Joint deformity or stiffness in the affected hand that prevents the use of thedynamic orthosis;

  3. Diagnosis of other neurological disorders affecting motor control, such as neglect,Parkinson's disease, etc.;

  4. Inability to follow therapist guidance;

  5. Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Dynamic-orthosis
Phase:
Study Start date:
January 22, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • National Cheng Kung University

    Tainan, 701
    Taiwan

    Active - Recruiting

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