UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038638 |
|---|---|
| Receipt number | R000043973 |
| Scientific Title | Effect of Fascial Manipulation on Reaction Time. |
| Date of disclosure of the study information | 2019/11/25 |
| Last modified on | 2019/11/19 19:13:59 |
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Basic information
Public title
Effect of Fascial Manipulation on Reaction Time.
Acronym
Effect of Fascial Manipulation on Reaction Time.
Scientific Title
Effect of Fascial Manipulation on Reaction Time.
Scientific Title:Acronym
Effect of Fascial Manipulation on Reaction Time.
Region
| Japan |
Condition
Condition
Healthy adult participants.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effects of Fascial Manipulation on muscle force and electrical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle activity and force(before the intervention, immediately after the intervention and one week after the intervention)
Key secondary outcomes
We calculated Reaction Time (RT), Pre-Motor Time (PMT), Motor Time (MT), Time to Peak Force (TPF), and Time to Peak Activity (TPA) from primary outcomes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The fascial manipulation intervention group receives fascial manipulation onece for the right brachial fascia(AN-CU), (210 seconds).
Interventions/Control_2
The static stretching intervention group receives static stretching onece for the right biceps brachii(210 seconds).
Interventions/Control_3
The control group lies supine for 210 seconds.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy adult participants(30 males and 30 females)
Key exclusion criteria
History of traumatic injury or impairment of their upper limbs.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Sawamura |
Organization
Kizawa Memorial Hospital
Division name
Department of General Rehabilitation
Zip code
505-0034
Address
590 Shimokobi, Kobi-cho, Minokamo-City, Gifu
TEL
+81-574-25-2181
sawarm123@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Sawamura |
Organization
Kizawa Memorial Hospital
Division name
Department of General Rehabilitation
Zip code
505-0034
Address
590 Shimokobi, Kobi-cho, Minokamo-City, Gifu
TEL
+81-574-25-2181
Homepage URL
sawarm123@yahoo.co.jp
Sponsor or person
Institute
Kizawa Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Education and Research Support Division, Chubu Gakuin University
Address
2-1 Kirigaoka, Seki-City, Gifu
Tel
+81-575-24-2238
cgrd@chubu-gu.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
| 2019 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
It is not open to the public.
Publication of results
Unpublished
Result
URL related to results and publications
We do not disclose any information other than what is described on this site.
Number of participants that the trial has enrolled
60
Results
The Reaction Time (RT), Motor Time (MT), Time to Peak Force (TPF) and Time to Peak Activity (TPA)of the FM group were significantly shorter immediately after or one week after the intervention compared with those before the intervention. The RT, MT, TPA and TPF of the FM group were significantly shorter than SS group or C group immediately after or one week after the intervention.
Results date posted
| 2019 | Year | 11 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We recruited sixty healthy adult participants (30 males and 30 females, mean age: 26.4 years old). Participants had no history of traumatic injury or impairment of their upper limbs.
Participant flow
We recruited participants for posting posters at Kizawa Memorial Hospital.
Adverse events
None
Outcome measures
muscle activity of right biceps brachii and bending force of the right elbow joint
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043973
