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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038287
Receipt No. R000043306
Scientific Title Development of the system using mixed reality aimed at improving voluntary motor function in the paralyzed upper limb in stroke patients and relieving phantom pain in upper-limb amputees
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/14

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Basic information
Public title Development of the system using mixed reality aimed at improving voluntary motor function in the paralyzed upper limb in stroke patients and relieving phantom pain in upper-limb amputees
Acronym Development of the system using mixed reality aimed at improving voluntary motor function in the paralyzed upper limb in stroke patients and relieving phantom pain in upper-limb amputees
Scientific Title Development of the system using mixed reality aimed at improving voluntary motor function in the paralyzed upper limb in stroke patients and relieving phantom pain in upper-limb amputees
Scientific Title:Acronym Development of the system using mixed reality aimed at improving voluntary motor function in the paralyzed upper limb in stroke patients and relieving phantom pain in upper-limb amputees
Region
Japan

Condition
Condition Hemiparesis after stroke; phantom limb pain after amputation.
Classification by specialty
Neurology Orthopedics Neurosurgery
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the efficacy and to identify problems towards practical use of "Mixed reality rehabilitation system for patients with upper-extremity impairment", which Kitasato University and Shanti Inc. are developing. We will examine also contents for patients after lower extremity amputation, under development according to the contents for patients after upper extremity amputation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motor function of paralysed upper extremity in patients after stroke
Sense of voluntary movement of phantom limb in patients after amputation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention group receives usual rehabilitation and performs movement observation as the intervention of this study below.
Patients after stroke or upper extremity amputation perform flexion/extension of fingers, ulnar adduction/radial abduction of carpometacarpal joint of the thumb, opposing thumb to finger, radial/ulnar flexion and palmar/dorsal flexion of the wrist, pronation/supination of the forearm, in healthy upper extremity, 20 times, and observe movements in virtual upper extremity, which reflects the previous movements, considering as though the affected upper extremity moved actively.
Patients after lower extremity amputation perform flexion/extension of toes, adduction/abduction, inversion/eversion and plantar/dorsal flexion of the ankle, flexion/extension of the knee, in healthy lower extremity, 20 times, and observe movements in virtual lower extremity, which reflects the previous movements, considering as though the affected lower extremity moved actively.
Interventions/Control_2 Control group receives usual rehabilitation and no intervention of this study.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke patients at Brunnstrom recovery stage 5 or less for the upper limb or hand, or patients after unilateral amputation of upper or lower limb, who has hospitalised in Fujigaoka Rehabilitation Hospital from 1st October 2019 to 31st March 2021.
Key exclusion criteria Patients who have been diagnosed as dementia; who cannot perform movements as the intervention after receiving the explanation (regardless of the cause such as decreased motor function in healthy limb, decreased sitting balance, decreased cognitive function); who have a history of fracture in paralysed upper limb or present peripheral nerve dysfunction.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Naonobu
Middle name
Last name Takahira
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code 252-0373
Address 15-1, Kitasato 1, Minami-ku, Sagamihara-shi, Kanagawa-ken
TEL 0427788111
Email takahira@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Naonobu
Middle name
Last name Takahira
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code 252-0373
Address 15-1, Kitasato 1, Minami-ku, Sagamihara-shi, Kanagawa-ken
TEL 0427788111
Homepage URL
Email takahira@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Industrial Labor Bureau, Kanagawa-ken
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kitasato University Medical Ethics Organization
Address 15-1, Kitasato 1, Minami-ku, Sagamihara-shi, Kanagawa-ken
Tel 0427788273
Email rinrib@med.kitasato-u.ac.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 昭和大学藤が丘リハビリテーション病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 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
2019 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2021 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
2019 Year 10 Month 14 Day
Last modified on
2019 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043306

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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