UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052963 |
|---|---|
| Receipt number | R000060423 |
| Scientific Title | Clinical Evaluation of Gait Assistive System and Metaverse Environment in Stroke Neurorehabilitation |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/12/01 01:04:45 |
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Basic information
Public title
Clinical Evaluation of Gait Assistive System and Metaverse Environment in Stroke Neurorehabilitation
Acronym
Clinical Evaluation of Gait Assistive System and Metaverse Environment in Stroke Neurorehabilitation
Scientific Title
Clinical Evaluation of Gait Assistive System and Metaverse Environment in Stroke Neurorehabilitation
Scientific Title:Acronym
Clinical Evaluation of Gait Assistive System and Metaverse Environment in Stroke Neurorehabilitation
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying and evaluating the effects on gait, voluntariness, and brain activity using the developed gait assistive system and metaverse environment in rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coordinates and force of the lower limbs , gait data, surface electromyography, electroencephalogram, video recording during the experiment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Purpose: Verify the intervention effects of instant support and delayed support using gait assistive system
Subject:
Intervention group A (immediate assistance): Approximately 10 patients with stroke hemiplegia (Brunstrom stage III to VI)
Intervention group B (delayed assistance): Approximately 10 patients with stroke hemiplegia (Brunstrom stage III to VI)
Intervention group C (delayed assistance, delay adjusted each time): Approximately 10 patients with stroke hemiplegia (Brunstrom stage III to VI), Approximately 10 healthy subjects
Time: About 30 minutes in total
Measurement items: Physical quantities such as coordinates, angle, and force of the lower limbs, gait data, and surface electromyography
Interventions/Control_2
Purpose: To verify the mid-term effects of support using a walking support system
Subject:
Intervention group: Approximately 10 patients with stroke hemiplegia (Brunstrom stage III to VI)
Control group: Approximately 10 stroke hemiplegia patients (Brunstrom stage III to VI)
Time: 2 weeks, about 3 times a week (about 6 times in total), about 20 minutes each time, about 10 minutes for data measurement
Measurement items: Physical quantities such as coordinates, angle, and force of the lower limbs, gait data, and surface electromyography
Interventions/Control_3
Purpose: To verify the influence of MR screen presentation on gait and brain activity during gait training
Subject:
Approximately 10 patients with hemiplegia due to stroke (Brunstrom stage III to VI)
Approximately 10 healthy people (possible to take the same exam as I)
Time: About 40 minutes in total
Measurement items: Physical quantities such as coordinates, angle, and force of the lower limbs, gait data, and brain waves
Interventions/Control_4
Purpose: To verify the effects on gait, surface electromyography, and brain activity by intervening with the system that integrates delayed support with high dorsiflexion assistance and MR environment.
Subject:
Approximately 10 stroke hemiplegia patients (Brunstrom stage III to VI)
Approximately 10 healthy people (possible to take multiple exams for I and II)
Time: About 40 minutes in total
Measurement items: Physical quantities such as coordinates, angle, and force of the lower limbs, gait data, surface electromyography, and electroencephalogram
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
Patients with hemiplegia who wish to participate in training using a motor support device or MR system and who meet the following criteria:
1. Lower extremity Brunstrom stage III to VI
2.No higher brain dysfunction
3.The attending physician and medical therapist of the affiliated hospital can determine that there is no problem in conducting the test
Key exclusion criteria
1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis or pericarditis
4. Unstable angina
5. Acute systemic or pulmonary embolism
6. Acute infection
7. Thrombophlebitis
8. Ventricular tachycardia or refractory ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
10. Uncontrolled arterial or pulmonary hypertension
11. A target of another intervention study at the same time (confirm verbally with your physical therapist)
* Exclusion criteria will be determined by the physician who helps with the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
162-0042
Address
Room 603, Green Computing Systems Research Organization, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
162-0042
Address
Room 603, GCS, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Ethics Review Committee
Address
2F Building No. 9, 1-104 Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.jp
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
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060423
