UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038287 |
|---|---|
| Receipt number | 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 | 2021/10/19 08:44:16 |
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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
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
takahira@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043306
