StrokeNCT06271187
Dynamic-orthosis Programs for Stroke Hand Function
A study testing Dynamic-orthosis and Traditional stroke occupational therapy training in people with Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dynamic-orthosis and Traditional stroke occupational therapy training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Onset of stroke at least three months ago;
- Upper limb Brunnstrom stage II~IV;
- Shoulder can actively flex at least 45 degrees.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, 701
JER-HAO CHANG, PH.D., 886-6-2353535 ext. 5912, jerhao@ncku.edu.tw
About this study
Official title: Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke
This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- Dynamic-orthosis, Traditional stroke occupational therapy training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic-orthosisDevice
Engaging in motion training at home with the use of dynamic orthoses.
Traditional stroke occupational therapy trainingOther
Traditional post-stroke movement training arranged by an occupational therapist in a medical setting.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic-orthosis training group | Experimental | 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. Receives: Device: Dynamic-orthosis; Other: Traditional stroke occupational therapy training |
| Regular training group | Other | 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. Receives: Other: Traditional stroke occupational therapy training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment- Upper Extremity
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.
Measured: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Box and Block Test
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.
Measured: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Motor Activity Log
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.
Measured: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Secondary outcomes (2)
Modified Ashworth scale
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.
Measured: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Upper limb joint range of motion
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).
Measured: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start22 Jan 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Jer-Hao Chang, National Cheng-Kung University Hospital
- Investigators
- JERHAO CHANG, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271187
- Sponsor's protocol ID
- A-ER-110-507
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06271187
- Acronym / sponsor ID
- A-ER-110-507
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic-orthosis training group | Experimental | Device: Dynamic-orthosis, Other: Traditional stroke occupational therapy trainingParticipants 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. |
| Regular training group | Other | Other: Traditional stroke occupational therapy trainingParticipants 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Onset of stroke at least three months ago;
- Upper limb Brunnstrom stage II~IV;
- Shoulder can actively flex at least 45 degrees.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic-orthosisEngaging in motion training at home with the use of dynamic orthoses. | Device | Dynamic-orthosis training group |
| Traditional stroke occupational therapy trainingTraditional post-stroke movement training arranged by an occupational therapist in a medical setting. | Other | Dynamic-orthosis training group, Regular training group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Modified Ashworth scale
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Upper limb joint range of motion
Time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JERHAO CHANG, PhD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic-orthosis and Traditional stroke occupational therapy training in people with Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JERHAO CHANG (+886972272012, jerhao@ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment- Upper Extremity (time frame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.