UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017878 |
|---|---|
| Receipt number | R000020715 |
| Scientific Title | The case report on energy efficiency at anterior and posterior support type walker use in the 12 years of age or older with cerebral palsy patients |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2016/03/03 17:55:39 |
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Basic information
Public title
The case report on energy efficiency at anterior and posterior support type walker use in the 12 years of age or older with cerebral palsy patients
Acronym
Comparison of energy efficiency due to the difference in the cerebral palsy's walker
Scientific Title
The case report on energy efficiency at anterior and posterior support type walker use in the 12 years of age or older with cerebral palsy patients
Scientific Title:Acronym
Comparison of energy efficiency due to the difference in the cerebral palsy's walker
Region
| Japan |
Condition
Condition
Cerebral Palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing the energy efficiency when using anterior and posterior support type walker in 12 years of age or older with cerebral palsy patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
breath gas analysis data: oxygen uptake (VO2), carbon dioxide emissions (VCO2), ventilation once (VT), minute ventilation (VE), heart rate (HR), heart rate oxygen coefficient, work rate (WR), respiratory rate (RR), forced vital capacity (FVC)
gait evaluation: joint angle of trunk and hip and knee joint and ankle joint
in the initial contact, mid stance, pre-swing, mid swing.
Key secondary outcomes
General information: gender, age, medical history, weight, BMI · living conditions (walker of age, such as frequency of use)
gross motor function classification system (GMFCS)
gross motor ability measure (GMFM)
children with cerebral palsy hand finger operation capability system (MACS)
grip strength
joint range of motion: the shoulder,elbow,hip,knee and ankle joint
6 minutes walking test (walking distance)
10m comfortable walking (walking time, the number of steps)
Borg scale (subjective exercise intensity)
physiological cost index(PCI)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects perform sufficient practice in the anterior and posterior support type walker before walking evaluation, they get accustomed to both types of walker. Subjects it with the breath gas analyzer (K4b2), perform the 6 minutes walking test of one times for a total of two times in each walker to random. Subject is measured various breath gas indicator in a resting state of the 6 minutes walking test, and before and after 4 min. In addition, 6 minutes walking test is performed in two days. If the subject is using a brace from everyday, they are wearing a brace, and get walking in self pace. Gait assessment of the subject is analyzed taking the gait while walking 6 minutes walking test from the sagittal plane.
Interventions/Control_2
Subjects perform sufficient practice in the anterior and posterior support type walker before walking evaluation, they get accustomed to both types of walker. Subjects it with the breath gas analyzer (K4b2), perform the 6 minutes walking test of one times for a total of two times in each walker to random. Subject is measured various breath gas indicator in a resting state of the 6 minutes walking test, and before and after 4 min. In addition, 6 minutes walking test is performed in two days. If the subject is using a brace from everyday, they are wearing a brace, and get walking in self pace. Gait assessment of the subject is analyzed taking the gait while walking 6 minutes walking test from the sagittal plane.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
person who have been diagnosed with 12 years of age or older with cerebral palsy
Person can walker walking (that is gross motor function classification system is 3 or more
Key exclusion criteria
Those verbal communication, such as intellectual disability is difficult
Those with severe respiratory failure and cardiovascular-digestive
Other, If the doctor has determined is not the adaptation is the intervention
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daiki Nishiguchi |
Organization
Medical Corporation Association main subject Association
Oyamada Memorial Spa Hospital
Division name
Rehabilitation center
Zip code
Address
Yokkaichi, Mie Prefecture Yamada 5538-1
TEL
059-328-1260
reha-oya@syutaikai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiki Nishiguchi |
Organization
Medical Corporation Association main subject Association
Division name
Rehabilitation center
Zip code
Address
Mie Prefecture Yamada 5538-1
TEL
059-328-1260
Homepage URL
reha-oya@syutaikai.jp
Sponsor or person
Institute
Medical Corporation Association main subject Association
Oyamada Memorial Spa Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Association main subject Association
Oyamada Memorial Spa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | 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
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
| 2015 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020715
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