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NCT Number: NCT06271187

Dynamic-orthosis Programs for Stroke Hand Function

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 701, Taiwan

Location status: Recruiting

Location contact

JER-HAO CHANG, PH.D.

CONTACT

[email protected]

886-6-2353535 ext. 5912

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dynamic-orthosis

Device

Engaging in motion training at home with the use of dynamic orthoses.

Traditional stroke occupational therapy training

Other

Traditional post-stroke movement training arranged by an occupational therapist in a medical setting.

Primary outcomes

  1. Fugl-Meyer Assessment- Upper Extremity

    Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)

    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.

  2. Box and Block Test

    Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)

    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.

  3. Motor Activity Log

    Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)

    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.

Secondary outcomes

  1. Modified Ashworth scale

    Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)

    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.

  2. Upper limb joint range of motion

    Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment(Week 10 & Week 14)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

JERHAO CHANG

CONTACT

[email protected]

+886972272012

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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