UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054443 |
|---|---|
| Receipt number | R000062191 |
| Scientific Title | Effective exercise therapy using force control exercises for force steadiness and force accuracy during shoulder isometric contraction. |
| Date of disclosure of the study information | 2024/08/03 |
| Last modified on | 2025/07/30 14:37:57 |
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Basic information
Public title
Effective exercise therapy to improve the ability to force control at the shoulder joint.
Acronym
Effective exercise therapy to improve the ability to force control at the shoulder joint.
Scientific Title
Effective exercise therapy using force control exercises for force steadiness and force accuracy during shoulder isometric contraction.
Scientific Title:Acronym
Effective exercise therapy using force control exercises for FS and FA during shoulder isometric contraction.
Region
| Japan |
Condition
Condition
Diseases presenting with pain, instability and limited range of motion in the shoulder joint.
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to identify exercise therapies using force control tasks that are effective in improving force stability and force accuracy during shoulder isometric contractions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Force steadiness and forece accuracy before and after the intervention are the primary outcomes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform 10 sets of force control tasks for 15-60 seconds.
Exercise intensity (10-20% or 10-50% or 10-100% of maximal muscle strength)
Intensity change (constant intensity or multiple intensity or multi-stage change)
Frequency of intervention (once or 2 days a week for 1 week or 2 days a week for 2 weeks)
Interventions/Control_2
A control group without intervention will be established. The control group will rest for the 20 minutes it takes the intervention group to perform the exercise therapy and the primary outcome will be measured before and after the rest.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria include those who are familiar with the purpose and necessity of the study and who have voluntarily given their consent to co-operate in the study.
Key exclusion criteria
Exclusion criteria are minors and those aged 40 years or older, those with a history of cervicothoracic spine and upper limb or surgery, and those with pain or obvious functional impairment of the shoulder complex (sternoclavicular joint, acromioclavicular joint, scapulothoracic joint and glenohumeral joint).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Toda |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Science
Zip code
060-8556
Address
Minami 1-jo Nishi 2-chome Chuo-ku, Sapporo
TEL
0116112111
toda.h@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Toda |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Science
Zip code
060-8556
Address
Minami 1-jo Nishi 17-chome Chuo-ku, Sapporo
TEL
011-611-2111(ext.29210)
Homepage URL
toda.h@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical 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
Sapporo Medical University Ethics Committee
Address
Minami 1-jo Nishi 17-chome Chuo-ku, Sapporo
Tel
011-611-2111
rinri@sapmed.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
| 2024 | Year | 08 | Month | 03 | 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
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062191
