UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050078 |
|---|---|
| Receipt number | R000057049 |
| Scientific Title | Efficacy and Safety of Kinematic Control Exercise Therapy for Locomotive Syndrome |
| Date of disclosure of the study information | 2023/01/19 |
| Last modified on | 2025/01/20 11:42:02 |
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Basic information
Public title
Effectiveness of Kinematic Control Exercises for Locomotive Syndrome
Acronym
Effectiveness of Kinematic Control Exercises for Locomotive Syndrome
Scientific Title
Efficacy and Safety of Kinematic Control Exercise Therapy for Locomotive Syndrome
Scientific Title:Acronym
Effectiveness of Kinematic Control Exercises for Locomotive Syndrome
Region
| Japan |
Condition
Condition
locomotive diseases
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether exercise therapy with a kinematic control approach can be an effective option for preoperative and postoperative rehabilitation for locomotive diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related quality of life (SF-36)
Key secondary outcomes
Flexibility
Manual muscle testing (MMT)
Balance function
Gait speed
Spinal alignment and mobility
Muscle thickness of transversus abdominis, internal and external abdominal oblique muscles
Pain scale (NRS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
The exercise therapy program shall consist of kinematic control exercises [approximately 30 yoga exercises or 5 exercises using special Pilates equipment and 5 mat Pilates exercises, for a total of 10 exercises].
However, the number of exercises may be changed in consideration of the subject's motor functions and characteristics.
Inpatients will receive exercise therapy for 40 minutes each in the morning and afternoon, five days a week during their 2 to 4 weeks hospital stay.
Outpatients will receive intervention once a week for 40 minutes at a time for 5 months. In addition, patients will receive a handout illustrating a 5-disciplines program that can be implemented at home, and will perform kinematic control exercises at home at least twice a week.
Interventions/Control_2
The control group will be general healthy subjects who do not perform kinematic control exercises.
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with locomotive disease who have been deemed appropriate for locomotor therapy by their attending physician.
Key exclusion criteria
Those who have serious diseases other than locomotor diseases, infants, pregnant women, cognitively impaired, etc., who are judged by their attending physicians to be ineligible for exercise therapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junzo |
| Middle name | |
| Last name | Fujitani |
Organization
Tokushima University Graduate School
Division name
Department of Orthopedics, Institute of Biomedical Science
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7240
j.fujitani@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Junzo |
| Middle name | |
| Last name | Fujitani |
Organization
Tokushima University Graduate School
Division name
Department of Orthopedics, Institute of Biomedical Science
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Japan
TEL
088-633-7240
Homepage URL
j.fujitani@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Ethics Review Committee for Life Science and Medical Research, The University of Tokushima Hospital
Address
2-50-1 Kuramoto-cho Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As the application for modification of the research plan was approved by the Ethics Review Committee on September 30, 2024, the registration details were modified at this time based on the contents of the application.
Management information
Registered date
| 2023 | Year | 01 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057049
