UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049464 |
|---|---|
| Receipt number | R000056295 |
| Scientific Title | Relationship between the course of outpatient rehabilitation and trunk muscle strength and physical function in patients with lumbar spondylolysis |
| Date of disclosure of the study information | 2022/11/08 |
| Last modified on | 2024/02/06 19:57:20 |
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Basic information
Public title
Relationship between the course of outpatient rehabilitation and trunk muscle strength and physical function in patients with lumbar spondylolysis
Acronym
Relationship between the course of outpatient rehabilitation and trunk muscle strength and physical function in patients with lumbar spondylolysis
Scientific Title
Relationship between the course of outpatient rehabilitation and trunk muscle strength and physical function in patients with lumbar spondylolysis
Scientific Title:Acronym
Relationship between the course of outpatient rehabilitation and trunk muscle strength and physical function in patients with lumbar spondylolysis
Region
| Japan |
Condition
Condition
lumbar spondylolysis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between the course of outpatient rehabilitation and trunk muscle strength and physical function in patients with lumbar spondylolysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First and second to fifth isokinetic trunk muscle strength
Key secondary outcomes
Date of return to competition, pain, ROM, muscle strength
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
| 6 | years-old | < |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A case of rehabilitation for a diagnosis of lumbar spondylolysis.
Key exclusion criteria
Cases in which isokinetic trunk muscle strength was not performed.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
School of Physical Therapy
Zip code
350-0496
Address
981 Kawakado, Moroyama, Iruma District, Saitama
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Hamada |
Organization
Saitama Medical University Graduate school
Division name
rehabilitation medicine
Zip code
350-0496
Address
981 Kawakado. Moroyama. Iruma. Saitama
TEL
049-295-1001
Homepage URL
y.hamada@ymail.ne.jp
Sponsor or person
Institute
Saitama Medical University Graduate school
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Graduate school
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
Saitama medical center ethics committee
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550
Tel
049-228-3902
smcrinri@saitama-med.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 | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Not applicable.
Publication of results
Published
Result
URL related to results and publications
Not applicable.
Number of participants that the trial has enrolled
28
Results
Flexion and extension and maximum torque/body weight ratio were significantly lower First compared to 1M at all angular velocities (p < 0.05). Maximum torque generation time was significantly lower for First at 120/s and 180/s than at 1M ( p < 0.05). Correlations with the number of days to return to sports competition were detected at 60/s for maximum torque generation time (p < 0.05, r = 0.65).
Results date posted
| 2024 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study is a case-control study following the Checklist for Observational Studies in Epidemiology. The present study included patients diagnosed with lumbar spondylolysis from October 2015 to October 2022 who underwent isokinetic trunk muscle strength testing at the direction of their primary care physician.
Participant flow
Subjects with applicable fresh fracture cases were included in the study. The attending physician placed all subjects in a corset and exercise was discontinued.
Adverse events
Not applicable.
Outcome measures
An isokinetic testing machine (Biodex System 3, Biodex Corp., Shirley, NY, USA) was used to measure isokinetic trunk flexion/extension muscle strength. The Biodex Dual Position Back Ex/Flex Attachment was connected to the dynamometer. All subjects performed approximately three minutes of cycling or simple sit-ups as a warm-up before measurements were taken. The starting position was set according to the method suggested by Grabiner et al. and adjustable pads were placed behind the head, upper trunk and pelvis to secure the participant to the back attachment. The upper trunk, pelvis, and thighs were stabilized with straps. The measured range of motion (ROM) of the spine was 65 to 135 and angular velocities of 60/s, 120/s and 180/s were measured. The subject was instructed to perform three trunk exercises at set ROM and three speeds. Before the measurement was taken, it was fully explained to each patient and practiced at each angular velocity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2022 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056295
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