UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058750 |
|---|---|
| Receipt number | R000067174 |
| Scientific Title | Examining optimal load during wheelchair propulsion movement with a focus on muscle coordination and its application to wheelchair athletes |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/09 14:55:52 |
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Basic information
Public title
Examining optimal load during wheelchair propulsion movement with a focus on muscle coordination and its application to wheelchair athletes
Acronym
Wheelchair Propulsion Load Trial
Scientific Title
Examining optimal load during wheelchair propulsion movement with a focus on muscle coordination and its application to wheelchair athletes
Scientific Title:Acronym
Optimal Load for Wheelchair Propulsion Study
Region
| Japan |
Condition
Condition
Healthy, lower limb amputation, spinal cord injury, congenital limb deficiency, cerebral palsy, polio, spina bifida
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To determine the optimal load for competitive wheelchairs that can maintain muscle synergy during propulsion motion.
2. To expand the scope of verification to include wheelchair basketball players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity
Key secondary outcomes
Joint angle, 20 m running time
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
No load
Interventions/Control_2
10% of body weight load
Interventions/Control_3
20% of body weight load
Interventions/Control_4
30% of body weight load
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1. males aged between 18 and 50 y.o. at the time of consent
2. who do not have a history of orthopaedic disease of the upper limb within the last two months, based on the time of measurement.
3. who can give written consent to participate in this study.
Key exclusion criteria
Persons with orthopaedic disorders of the upper limbs at the time of consent (except for disorders that are the basis for participation in competitions)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
makoto-komiya@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Komiya |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
TEL
0252574723
Homepage URL
makoto-komiya@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
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
Ethics committee of Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, Japan
Tel
025-257-4455
rinri@nuhw.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
| 2025 | Year | 09 | 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
| 2025 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067174
