UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047752 |
|---|---|
| Receipt number | R000053656 |
| Scientific Title | The effects of a robot on gait for patients with Down syndrome |
| Date of disclosure of the study information | 2022/06/11 |
| Last modified on | 2022/11/11 15:42:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of a robot on gait for patients with Down syndrome
Acronym
The effects of a robot on gait for patients with Down syndrome
Scientific Title
The effects of a robot on gait for patients with Down syndrome
Scientific Title:Acronym
The effects of a robot on gait for patients with Down syndrome
Region
| Japan |
Condition
Condition
Down syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effects of Honda Walking Assist on gait performance and kinematic pattern of patients with Down syndrome over 18 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
range of motion of hip, knee and ankle during gait
Key secondary outcomes
peak value of hip, knee and ankle during gait, lower limb segment position coordinates, gait speed, step length, stride length, step width, cadence, Beighton Hypermobility Score, muscle strength of knee extensor, Gross Motor Function Measure, Ratio of medial longitudinal arch height to foot length
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 46 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)18 years old or older
2)able to walk independently
3)height140cm-180cm or hip width 64cm-105cm
4)able to express themselves when they need a break
5)have sufficient cognitive ability to carry out the research
Key exclusion criteria
1)the presence of orthopedic problems that interfere with daily life
2)the presence of respiratory, circulatory, urological, or digestive disorders that limit movement
3)not able to wear the robot due to other reasons
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
606-8507
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3918
ohata.koji.7n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ohata |
Organization
Graduate school of Medicine, Kyoto University
Division name
Department of Human Health Sciences
Zip code
606-8507
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3918
Homepage URL
ohata.koji.7n@kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate school of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 11 | 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
11
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
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will examine the effects on gait when a gait training robot is used for persons with Down syndrome. This will lead to the development of gait practice methods for persons with Down syndrome.
Management information
Registered date
| 2022 | Year | 05 | Month | 13 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053656
