Usability and Effectiveness of a Novel Bilateral Upper Limb Training Device for Stroke Patients With Hemiparesis: A Preliminary Study
NCT ID: NCT06956677
Last Updated: 2025-05-04
Study Results
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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COMPLETED
NA
66 participants
INTERVENTIONAL
2023-09-05
2024-11-30
Brief Summary
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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: [email protected]
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Intervention includes 30 minutes of UE functional training and 1 hour of conventional occupational therapy.
The UE functional training
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 therapy
Conventional occupational therapy
Experimental group
Intervention consists of 30 minutes of novel UE rehabilitation device training and 1 hour of conventional occupational therapy.
Novel UE rehabilitation device training
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.
Conventional occupational therapy
Conventional occupational therapy
Interventions
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Novel UE rehabilitation device training
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 training
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 therapy
Conventional occupational therapy
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 70 years
3. Stable physiological and neurological status (no neurological deterioration and stable vital signs for ≥72 hours; complications resolved or medically managed)
4. Adequate cognitive function to follow at least two-step commands
5. Willingness to provide written informed consent
6. Unilateral upper extremity (UE) hemiplegia
7. Brunnstrom stage \> I for proximal UE motor function
8. UE muscle tone \< 3 on the Modified Ashworth Scale
Exclusion Criteria
2. Other neurological disorders
3. Orthopedic conditions affecting the UE
4. Active or non-healed dermatological lesions
18 Years
70 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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New Taipei Municipal TuCheng Hospital
New Taipei City, , Taiwan
Countries
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References
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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.
Ma 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.
Shahid 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.
Nair 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.
Langhorne 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.
Johnson 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.
Mehrholz 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.
Poli 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.
Trombly 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.
Paci 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.
Parker 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.
McCrea 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.
Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202301097A3
Identifier Type: -
Identifier Source: org_study_id
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