Unique ID issued by UMIN | UMIN000044590 |
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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 |
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
Asia(except Japan) |
Experiment on rehabilitation targeting stroke patients using mixed reality rehabilitation
Neurology | Rehabilitation medicine | Adult |
Others
NO
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.
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
Confirmatory
Explanatory
Phase I
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.
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.
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
No treatment
NO
NO
Institution is considered as adjustment factor in dynamic allocation.
NO
Numbered container method
2
Treatment
Maneuver |
rehabilitation without mixed reality rehabilitation
Healthy individuals who does not require rehabilitation will be going through the same length of process as others
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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.
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.
30
1st name | Ping-Chia |
Middle name | |
Last name | Li |
I-Shou Univeristy
Department of Occupational Therapy
82445
No. 8, Yida Rd., Tanchao Township, Kaohsiung, Taiwan
886761511007513
pingchiali@gmail.com
1st name | Ping-Chia |
Middle name | |
Last name | Li |
I-Shou Univeristy
Department of Occupational Therapy
82445
No. 8, Yida Rd., Tanchao Township, Kaohsiung, Taiwan
886761511007513
pingchiali@gmail.com
Ministry of science and technology, Republic of China
MOST 105-2321-B-214-001
Ministry of science and technology, Republic of China
MOST 105-2321-B-214-001
Local Government
Republic of China, Taiwan
Institutional review board of E-Da hospital
No. 6 Yida road, jiaosu village, yanchao district, kaohsiung city, 82445, Republic of China, Taiwan
886761511005111
ed103800@edah.org.tw
NO
2022 | Year | 05 | Month | 15 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 08 | Month | 01 | Day |
2021 | Year | 05 | Month | 16 | Day |
2021 | Year | 12 | Month | 01 | Day |
2023 | Year | 05 | Month | 15 | Day |
2021 | Year | 06 | Month | 18 | Day |
2021 | Year | 06 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050906
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