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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044590
Receipt No. R000050906
Scientific Title Efficacy and evaluation of the application of mixed reality rehabilitation training coupled with artificial intelligence analysis software for upper limb rehabilitation in stroke patients
Date of disclosure of the study information 2022/05/15
Last modified on 2021/06/18

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Basic information
Public title Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Acronym Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Scientific Title Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Scientific Title:Acronym Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Region
Asia(except Japan)

Condition
Condition Experiment on rehabilitation targeting stroke patients using mixed reality rehabilitation
Classification by specialty
Neurology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 combine mixed reality rehabilitation to deliver a standardized intervention,
subject will follow the virtual coach with same movement, and every action will be recorded and scored by software. Our primary goal
is to evaluate training dose and intensity in stroke patient by using
Fugl-Meyer Assessment-lower extremity (FMA-LE), Maximum walking speed
(MWS), Berg Balance Scale (BBS), Stroke Impact Scale (SIS), Modified
Rankin Scale (MRS), Barthel Index (BI). Secondary, we measured safety
and acceptance by record the adverse effect with occurrence frequency,
and satisfaction rated by subjects.
Basic objectives2 Others
Basic objectives -Others Additionally, we analysis the serum level of oxidative stress by
superoxide and 8-OHdG; inflammation cytokine IL-6, TNF-alpha;
neuroplasticity biomarker BDNF, and the putative signal transduction pathway will be discussed further
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Results shown that upper limb function (FMA-UE), biomarkers correlated to oxidative stress (HO-1 and 8-OHdG), and BDNF have significant improvement after mixed reality rehabilitation trainings.
Key secondary outcomes Although the change of serum molecular in mixed reality rehabilitation group did not reached significance compared to the control group. It is also suggests that the motor recovery was associated with the increase of HO-1 and decrease of 8-OHdG.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 rehabilitation without mixed reality rehabilitation
Interventions/Control_2 Healthy individuals who does not require rehabilitation will be going through the same length of process as others
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria patient age between 20 to 75 years, first onset of stroke over 3 months. Brunnstrom stage higher than 3, having a diagnosis with stroke and confirmed with Computed tomography or Magnetic Resonance Imaging scans, being able to understand instructions, Mini-Mental State Examination score higher than 18 and, no other neurological disorders as comorbid.
Key exclusion criteria participated in other rehabilitation related or clinical trials within 3 months of the experiment, having sensory apraxia, having severe impairments in vision or visual perception such as hemi-neglect, receiving warfarin or VitK antagonist treatment, having high risk of epilepsy, failure to cooperate with the researcher to execute mixed reality rehabilitation activities and refusing to take the blood test.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ping-Chia
Middle name
Last name Li
Organization I-Shou Univeristy
Division name Department of Occupational Therapy
Zip code 82445
Address No. 8, Yida Rd., Tanchao Township, Kaohsiung, Taiwan
TEL 886761511007513
Email pingchiali@gmail.com

Public contact
Name of contact person
1st name Ping-Chia
Middle name
Last name Li
Organization I-Shou Univeristy
Division name Department of Occupational Therapy
Zip code 82445
Address No. 8, Yida Rd., Tanchao Township, Kaohsiung, Taiwan
TEL 886761511007513
Homepage URL
Email pingchiali@gmail.com

Sponsor
Institute Ministry of science and technology, Republic of China
MOST 105-2321-B-214-001
Institute
Department

Funding Source
Organization Ministry of science and technology, Republic of China
MOST 105-2321-B-214-001
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Republic of China, Taiwan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional review board of E-Da hospital
Address No. 6 Yida road, jiaosu village, yanchao district, kaohsiung city, 82445, Republic of China, Taiwan
Tel 886761511005111
Email ed103800@edah.org.tw

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 08 Month 01 Day
Date of IRB
2021 Year 05 Month 16 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2023 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 18 Day
Last modified on
2021 Year 06 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050906

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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