UMIN-CTR Clinical Trial

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	3
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	Terminated
Date of protocol fixation	2019 Year 10 Month 14 Day
Date of IRB	2019 Year 12 Month 04 Day
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	2021 Year 10 Month 19 Day

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