UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044590
Receipt number 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 16:07:02

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
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