Dynamic-orthosis Programs for Stroke Hand Function

NCT ID: NCT06271187

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynamic-orthosis training group

Participants will undergo traditional occupational therapy (2-3 times per week, one hour per session, for a total of six weeks), supplemented with an additional home-based dynamic orthotic therapy program (five days per week, one hour per session, for six weeks). The style of the dynamic orthosis will be selected by the researchers based on the participants' movement performance and rehabilitation goals, and it will be adjusted or replaced as their abilities progress.

Group Type EXPERIMENTAL

Dynamic-orthosis

Intervention Type DEVICE

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

Traditional stroke occupational therapy training

Intervention Type OTHER

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

Regular training group

Participants will receive traditional occupational therapy (2-3 sessions per week, one hour per session, for a total of six weeks). The training program includes muscle strength training, reaching and grasping exercises, manual tone control, motor facilitation, and activities of daily living training. During the study period, participants will not wear any hand dynamic orthosis during training.

Group Type OTHER

Traditional stroke occupational therapy training

Intervention Type OTHER

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

Interventions

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Dynamic-orthosis

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

Intervention Type DEVICE

Traditional stroke occupational therapy training

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

Intervention Type OTHER

Eligibility Criteria

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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 Criteria

1. Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;
2. Joint deformity or stiffness in the affected hand that prevents the use of the dynamic 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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jer-Hao Chang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JERHAO CHANG, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

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National Cheng Kung University

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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JERHAO CHANG

Role: CONTACT

Phone: +886972272012

Email: [email protected]

Facility Contacts

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JER-HAO CHANG, PH.D.

Role: primary

Other Identifiers

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A-ER-110-507

Identifier Type: -

Identifier Source: org_study_id