| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Behavioral: Augmented Reality with Functional Electrical Stimulation group Behavioral: Traditional physiotherapy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke |
| Actual Study Start Date : | October 10, 2019 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | March 15, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Augmented reality with functional electrical stimulation group
Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.
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Behavioral: Augmented Reality with Functional Electrical Stimulation group
Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.
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Active Comparator: Traditional physiotherapy group
Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.
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Behavioral: Traditional physiotherapy
Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .
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Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows:
0: No increase in muscle tone
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Chien-Hung Lai, MD PhD | 886-2-27372181 ext 3538 | chlai@tmu.edu.tw |
| Taiwan | |
| Taipei Medical university Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Chien-Hung Lai, MD PhD | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 27, 2019 | ||||
| First Posted Date ICMJE | July 1, 2019 | ||||
| Last Update Posted Date | December 13, 2019 | ||||
| Actual Study Start Date ICMJE | October 10, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke | ||||
| Official Title ICMJE | Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke | ||||
| Brief Summary | This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10). | ||||
| Detailed Description | Participants will be randomized allocated to two groups: Augmented Reality and Functional Electrical Stimulation group , and traditional physiotherapy group. All participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training. Functional Magnetic Resonance Imaging (fMRI) with Diffusion Tensor Imaging (DTI), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), 10 meter walking test will be assessed before and after intervention in all participants. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
20 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | March 15, 2021 | ||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Taiwan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04003571 | ||||
| Other Study ID Numbers ICMJE | N201904041 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Lai chien hung, Taipei Medical University Hospital | ||||
| Study Sponsor ICMJE | Taipei Medical University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Taipei Medical University Hospital | ||||
| Verification Date | December 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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