UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038638
Receipt No. 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 (Ver. 1)

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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
Email 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
Email sawarm123@yahoo.co.jp

Sponsor
Institute Kizawa Memorial Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043973