The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With StrokeSynslaiNCT06956677
Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study
A study testing Novel UE rehabilitation device training, The UE functional training and Conventional occupational therapy in people with The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background and Study Aims Stroke is a leading cause of long-term disability worldwide, affecting millions of individuals each year. After experiencing a stroke, many patients face challenges with their upper limbs, resulting in difficulties in performing daily activities. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke
- What is being tested?
- Novel UE rehabilitation device training, The UE functional training and Conventional occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed stroke diagnosis by imaging, with onset within the past 12 months
- Age between 18 and 70 years
- Stable physiological and neurological status (no neurological deterioration and stable vital signs for ≥72 hours; complications resolved or medically managed)
- Adequate cognitive function to follow at least two-step commands
- Willingness to provide written informed consent
- Unilateral upper extremity (UE) hemiplegia
- Brunnstrom stage > I for proximal UE motor function
- UE muscle tone < 3 on the Modified Ashworth Scale
Who cannot join
- Cognitive impairment
- Other neurological disorders
- Orthopedic conditions affecting the UE
- Active or non-healed dermatological lesions
Trial locations and contacts
1 site in 1 country.
About this study
Background and Study Aims Stroke is a leading cause of long-term disability worldwide, affecting millions of individuals each year. After experiencing a stroke, many patients face challenges with their upper limbs, resulting in difficulties in performing daily activities. This study aims to evaluate a new rehabilitation device designed to assist stroke patients with hemiparesis (weakness on one side of the body) in improving their upper limb function. The goal is to determine if this device can effectively support recovery while providing an affordable and accessible option for rehabilitation.
Who Can Participate? This study is open to adults aged between 18 and 70 years, regardless of sex. To participate, individuals must have a confirmed diagnosis of hemiplegic stroke, which means they must experience weakness in one side of the body. Participants should have had their stroke within the last 12 months and must be able to follow simple commands. Those with cognitive impairments, other neurological disorders, certain orthopedic conditions affecting the upper limb, or active skin issues will not be eligible.
Read more
What Does the Study Involve? Participants in this study will be randomly assigned to two groups: one group will use the new rehabilitation device, while the other will receive conventional occupational therapy. Both groups will undergo an assessment before and after the intervention to measure their improvement in upper limb function. The device encourages exercises that are essential for fostering movement recovery, while the conventional therapy focuses on traditional rehabilitation methods. Participants will have their upper limb function evaluated through established assessment tools to gauge progress.
What Are the Possible Benefits and Risks of Participating? By participating in this study, individuals may experience improvements in their upper limb function, leading to increased independence and enhanced quality of life. Additionally, participants will contribute to valuable research that could improve rehabilitation strategies for future stroke patients. While the rehabilitation device is designed to be safe, some individuals may experience mild discomfort or fatigue from the exercises. However, serious side effects are rare. Participants are encouraged to discuss any concerns with the research team.
Where Is the Study Run From? The study is being conducted at New Taipei Municipal TuCheng Hospital in Taiwan, specifically in the rehabilitation ward, where trained medical professionals oversee the research process.
When Is the Study Starting and How Long Is It Expected to Run For? The study commenced in September 2023 and is expected to continue through November 2024. This timeline allows for recruiting participants and thorough data collection to assess the device's effectiveness.
Who Is Funding the Study? This study does not have external funding and is being conducted independently by the researchers involved. All costs associated with the study, including participant care and device usage, are covered by the resources of the conducting institution.
Who Is the Main Contact?
For more information about this study, please contact:
Kuo-Cheng, Liu Position: Research Coordinator Email address: monhh159@gmail.com
- Conditions
- The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke
- Being tested
- Novel UE rehabilitation device training, The UE functional training, Conventional occupational therapy
- Keywords
- Stroke, Hemiparesis, Usability, Bilateral Training, Upper Extremity Rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel UE rehabilitation device trainingDevice
The novel UE rehabilitation device training includes the single-joint exercise and dual-joint exercise, each performed 20 repetitions per set, for a total of 5 sets with 30-second rest intervals between sets.
The UE functional trainingOther
The UE functional training focuses on the affected arm, incorporating exercises such as push-pull boxes (standing or seated), alternating push-pull boxes, and hand-crank exercises.
Conventional occupational therapyOther
Conventional occupational therapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Intervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy. Receives: Other: The UE functional training; Other: Conventional occupational therapy |
| Experimental group | Experimental | Intervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy. Receives: Device: Novel UE rehabilitation device training; Other: Conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity
This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.
Measured: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
Secondary outcomes (2)
Brunnstrom stage
The Brunnstrom scale classifies motor recovery post-stroke into six stages, ranging from flaccid paralysis (Stage I) to near-normal voluntary control (Stage VI), and the higher stage represent the better outcome.
Measured: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
Modified Ashworth scale
This scale assesses the severity of muscle spasticity by quantifying resistance to passive movement on a scale from 0 (no increase in tone) to 4 (rigid in flexion or extension) and the higer scores represent the worse outcome.
Measured: Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start5 Sep 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Model description
- An investigator analyzed inclusion and exclusion criteria and assigned participants to one of the groups. Participants were randomly allocated to either the experimental group or the control group. Randomization and group allocation was performed by a research assistant using a computer-generated randomization sequence to ensure unbiased allocation. Each intervention was conducted over a 3-week period, consisting of 10 to 15 sessions.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956677
- Sponsor's protocol ID
- 202301097A3
- Acronym
- Synslai
- Status last verified
- Sep 2023
- First submitted
- 24 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analysed during the current study were available upon request from * Contact Name and Email Address: Dr. Kuo-Cheng Liu, email: monhh159@gmail.com * Type of Data Shared: Individual participant data (IPD) including demographic, assessments, interventions. * Availability: The dataset will be available upon request after the publication of study results. * Access Criteria: Researchers can request data by providing a brief description of their intended analysis, which should align with stroke rehabilitation research objectives. * Consent from Participants: Informed consent was obtained. * Anonymization Comments: Data will be anonymized to protect participant identities. * Ethical or Legal Restrictions: Following ethical guidelines and IRB requirements will guide the data-sharing process. * Other Comments: Participants' consents specify academic and appropriate use of data.
Publications
Sahu RK, Gugnani A, Ahluwalia R. Short-term effectiveness of trunk and bimanual hand training on upper limb motor recovery and function in stroke patients. International journal of health sciences. 05/15 2022;6(S1):10058-10071. doi:10.53730/ijhs.v6nS1.7384
Julien M, Laffont I, Bonnin H-Y, Liesjet V, Mottet D. Bimanual Coordination Being Efficient Around Two Months After Stroke: A Key Recovery Moment for Starting Bimanual Rehabilitation Protocols? BIO Web of Conferences. 12/01 2011;1doi:10.1051/bioconf/20110100062
Metrot J, Mottet D, Hauret I, van Dokkum L, Bonnin-Koang HY, Torre K, Laffont I. Changes in bimanual coordination during the first 6 weeks after moderate hemiparetic stroke. Neurorehabil Neural Repair. 2013 Mar-Apr;27(3):251-9. doi: 10.1177/1545968312461072. Epub 2012 Nov 7.
PubMed 23135767Ma D, Li X, Xu Q, Yang F, Feng Y, Wang W, Huang JJ, Pei YC, Pan Y. Robot-Assisted Bimanual Training Improves Hand Function in Patients With Subacute Stroke: A Randomized Controlled Pilot Study. Front Neurol. 2022 Jul 6;13:884261. doi: 10.3389/fneur.2022.884261. eCollection 2022.
PubMed 35873779Shahid J, Kashif A, Shahid MK. A Comprehensive Review of Physical Therapy Interventions for Stroke Rehabilitation: Impairment-Based Approaches and Functional Goals. Brain Sci. 2023 Apr 25;13(5):717. doi: 10.3390/brainsci13050717.
PubMed 37239189Nair KPST, A B. Stroke rehabilitation : traditional and modern approaches. 2002;
Tan CO. Is remote rehabilitation after stroke as effective as conventional therapy? Neurology. 2020 Oct 27;95(17):e2462-e2464. doi: 10.1212/WNL.0000000000010839. No abstract available.
PubMed 33106363Langhorne P, Legg L. Evidence behind stroke rehabilitation. J Neurol Neurosurg Psychiatry. 2003 Dec;74 Suppl 4(Suppl 4):iv18-iv21. doi: 10.1136/jnnp.74.suppl_4.iv18. No abstract available.
PubMed 14645462Johnson MJ, Rai R, Barathi S, Mendonca R, Bustamante-Valles K. Affordable stroke therapy in high-, low- and middle-income countries: From Theradrive to Rehab CARES, a compact robot gym. J Rehabil Assist Technol Eng. 2017 Jun 1;4:2055668317708732. doi: 10.1177/2055668317708732. eCollection 2017 Jan-Dec.
PubMed 31186929Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.
PubMed 30175845Poli P, Morone G, Rosati G, Masiero S. Robotic technologies and rehabilitation: new tools for stroke patients' therapy. Biomed Res Int. 2013;2013:153872. doi: 10.1155/2013/153872. Epub 2013 Nov 20.
PubMed 24350244Trombly CA, Ma HI. A synthesis of the effects of occupational therapy for persons with stroke, Part I: Restoration of roles, tasks, and activities. Am J Occup Ther. 2002 May-Jun;56(3):250-9. doi: 10.5014/ajot.56.3.250.
PubMed 12058514Paci M, Nannetti L, Casavola D, Lombardi B. Differences in motor recovery between upper and lower limbs: does stroke subtype make the difference? Int J Rehabil Res. 2016 Jun;39(2):185-7. doi: 10.1097/MRR.0000000000000172.
PubMed 27096715Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.
PubMed 3804600McCrea PH, Eng JJ, Hodgson AJ. Biomechanics of reaching: clinical implications for individuals with acquired brain injury. Disabil Rehabil. 2002 Jul 10;24(10):534-41. doi: 10.1080/09638280110115393.
PubMed 12171643
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06956677
- Acronym / sponsor ID
- Synslai / 202301097A3
- Conditions
- The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke
- Keywords
- Stroke, Hemiparesis, Usability, Bilateral Training, Upper Extremity Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 4 May 2025 (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.
Background and Study Aims Stroke is a leading cause of long-term disability worldwide, affecting millions of individuals each year. After experiencing a stroke, many patients face challenges with their upper limbs, resulting in difficulties in performing daily activities. This study aims to evaluate a new rehabilitation device designed to assist stroke patients with hemiparesis (weakness on one side of the body) in improving their upper limb function. The goal is to determine if this device can effectively support recovery while providing an affordable and accessible option for rehabilitation.
Who Can Participate? This study is open to adults aged between 18 and 70 years, regardless of sex. To participate, individuals must have a confirmed diagnosis of hemiplegic stroke, which means they must experience weakness in one side of the body. Participants should have had their stroke within the last 12 months and must be able to follow simple commands. Those with cognitive impairments, other neurological disorders, certain orthopedic conditions affecting the upper limb, or active skin issues will not be eligible.
What Does the Study Involve? Participants in this study will be randomly assigned to two groups: one group will use the new rehabilitation device, while the other will receive conventional occupational therapy. Both groups will undergo an assessment before and after the intervention to measure their improvement in upper limb function. The device encourages exercises that are essential for fostering movement recovery, while the conventional therapy focuses on traditional rehabilitation methods. Participants will have their upper limb function evaluated through established assessment tools to gauge progress.
What Are the Possible Benefits and Risks of Participating? By participating in this study, individuals may experience improvements in their upper limb function, leading to increased independence and enhanced quality of life. Additionally, participants will contribute to valuable research that could improve rehabilitation strategies for future stroke patients. While the rehabilitation device is designed to be safe, some individuals may experience mild discomfort or fatigue from the exercises. However, serious side effects are rare. Participants are encouraged to discuss any concerns with the research team.
Where Is the Study Run From? The study is being conducted at New Taipei Municipal TuCheng Hospital in Taiwan, specifically in the rehabilitation ward, where trained medical professionals oversee the research process.
When Is the Study Starting and How Long Is It Expected to Run For? The study commenced in September 2023 and is expected to continue through November 2024. This timeline allows for recruiting participants and thorough data collection to assess the device's effectiveness.
Who Is Funding the Study? This study does not have external funding and is being conducted independently by the researchers involved. All costs associated with the study, including participant care and device usage, are covered by the resources of the conducting institution.
Who Is the Main Contact?
For more information about this study, please contact:
Kuo-Cheng, Liu Position: Research Coordinator Email address: monhh159@gmail.com
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An investigator analyzed inclusion and exclusion criteria and assigned participants to one of the groups. Participants were randomly allocated to either the experimental group or the control group. Randomization and group allocation was performed by a research assistant using a computer-generated randomization sequence to ensure unbiased allocation. Each intervention was conducted over a 3-week period, consisting of 10 to 15 sessions.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: The UE functional training, Other: Conventional occupational therapyIntervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy. |
| Experimental group | Experimental | Device: Novel UE rehabilitation device training, Other: Conventional occupational therapyIntervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed stroke diagnosis by imaging, with onset within the past 12 months
- Age between 18 and 70 years
- Stable physiological and neurological status (no neurological deterioration and stable vital signs for ≥72 hours; complications resolved or medically managed)
- Adequate cognitive function to follow at least two-step commands
- Willingness to provide written informed consent
Key exclusion criteria (4 listed)
- Cognitive impairment
- Other neurological disorders
- Orthopedic conditions affecting the UE
- Active or non-healed dermatological lesions
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 |
|---|---|---|
| Novel UE rehabilitation device trainingThe novel UE rehabilitation device training includes the single-joint exercise and dual-joint exercise, each performed 20 repetitions per set, for a total of 5 sets with 30-second rest intervals between sets. | Device | Experimental group |
| The UE functional trainingThe UE functional training focuses on the affected arm, incorporating exercises such as push-pull boxes (standing or seated), alternating push-pull boxes, and hand-crank exercises. | Other | Control group |
| Conventional occupational therapyConventional occupational therapy | Other | Control group, Experimental group |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity
Time frame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.
2 secondary outcomes
Brunnstrom stage
Time frame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.
Modified Ashworth scale
Time frame: Outcome measurements were performed at three stages: before, during (after the 5th training session), and after (immediately following the final session) the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Results publicationSahu RK, Gugnani A, Ahluwalia R. Short-term effectiveness of trunk and bimanual hand training on upper limb motor recovery and function in stroke patients. International journal of health sciences. 05/15 2022;6(S1):10058-10071. doi:10.53730/ijhs.v6nS1.7384
- Results publicationJulien M, Laffont I, Bonnin H-Y, Liesjet V, Mottet D. Bimanual Coordination Being Efficient Around Two Months After Stroke: A Key Recovery Moment for Starting Bimanual Rehabilitation Protocols? BIO Web of Conferences. 12/01 2011;1doi:10.1051/bioconf/20110100062
- Results publication: PubMed 23135767Metrot J, Mottet D, Hauret I, van Dokkum L, Bonnin-Koang HY, Torre K, Laffont I. Changes in bimanual coordination during the first 6 weeks after moderate hemiparetic stroke. Neurorehabil Neural Repair. 2013 Mar-Apr;27(3):251-9. doi: 10.1177/1545968312461072. Epub 2012 Nov 7.
- Results publication: PubMed 35873779Ma D, Li X, Xu Q, Yang F, Feng Y, Wang W, Huang JJ, Pei YC, Pan Y. Robot-Assisted Bimanual Training Improves Hand Function in Patients With Subacute Stroke: A Randomized Controlled Pilot Study. Front Neurol. 2022 Jul 6;13:884261. doi: 10.3389/fneur.2022.884261. eCollection 2022.
- Results publication: PubMed 37239189Shahid J, Kashif A, Shahid MK. A Comprehensive Review of Physical Therapy Interventions for Stroke Rehabilitation: Impairment-Based Approaches and Functional Goals. Brain Sci. 2023 Apr 25;13(5):717. doi: 10.3390/brainsci13050717.
- Results publicationNair KPST, A B. Stroke rehabilitation : traditional and modern approaches. 2002;
- Results publication: PubMed 33106363Tan CO. Is remote rehabilitation after stroke as effective as conventional therapy? Neurology. 2020 Oct 27;95(17):e2462-e2464. doi: 10.1212/WNL.0000000000010839. No abstract available.
- Results publication: PubMed 14645462Langhorne P, Legg L. Evidence behind stroke rehabilitation. J Neurol Neurosurg Psychiatry. 2003 Dec;74 Suppl 4(Suppl 4):iv18-iv21. doi: 10.1136/jnnp.74.suppl_4.iv18. No abstract available.
- Results publication: PubMed 31186929Johnson MJ, Rai R, Barathi S, Mendonca R, Bustamante-Valles K. Affordable stroke therapy in high-, low- and middle-income countries: From Theradrive to Rehab CARES, a compact robot gym. J Rehabil Assist Technol Eng. 2017 Jun 1;4:2055668317708732. doi: 10.1177/2055668317708732. eCollection 2017 Jan-Dec.
- Results publication: PubMed 30175845Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.
- Results publication: PubMed 24350244Poli P, Morone G, Rosati G, Masiero S. Robotic technologies and rehabilitation: new tools for stroke patients' therapy. Biomed Res Int. 2013;2013:153872. doi: 10.1155/2013/153872. Epub 2013 Nov 20.
- Results publication: PubMed 12058514Trombly CA, Ma HI. A synthesis of the effects of occupational therapy for persons with stroke, Part I: Restoration of roles, tasks, and activities. Am J Occup Ther. 2002 May-Jun;56(3):250-9. doi: 10.5014/ajot.56.3.250.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analysed during the current study were available upon request from * Contact Name and Email Address: Dr. Kuo-Cheng Liu, email: monhh159@gmail.com * Type of Data Shared: Individual participant data (IPD) including demographic, assessments, interventions. * Availability: The dataset will be available upon request after the publication of study results. * Access Criteria: Researchers can request data by providing a brief description of their intended analysis, which should align with stroke rehabilitation research objectives. * Consent from Participants: Informed consent was obtained. * Anonymization Comments: Data will be anonymized to protect participant identities. * Ethical or Legal Restrictions: Following ethical guidelines and IRB requirements will guide the data-sharing process. * Other Comments: Participants' consents specify academic and appropriate use of data.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel UE rehabilitation device training, The UE functional training and Conventional occupational therapy in people with The Effectiveness of Novel Rehabilitation Device on Upper Limb Impairment Among Patients With Stroke, run by Chang Gung Memorial 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 4 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment for Upper Extremity (time frame: Outcome measurements were performed at three stages: before and after (immediately following the final session) the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956677, which also lists 17 linked publications.
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 4 May 2025.