UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050906