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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039511
Receipt No. R000045058
Scientific Title Anticipatory and compensatory postural muscle activities during voluntary movement in individuals with bilateral spastic cerebral palsy
Date of disclosure of the study information 2020/02/17
Last modified on 2020/02/17

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Basic information
Public title Anticipatory and compensatory postural muscle activities during voluntary movement in individuals with bilateral spastic cerebral palsy
Acronym Anticipatory and compensatory postural muscle activities during voluntary movement in individuals with bilateral spastic cerebral palsy
Scientific Title Anticipatory and compensatory postural muscle activities during voluntary movement in individuals with bilateral spastic cerebral palsy
Scientific Title:Acronym Anticipatory and compensatory postural muscle activities during voluntary movement in individuals with bilateral spastic cerebral palsy
Region
Japan

Condition
Condition Bilateral spastic cerebral palsy
Classification by specialty
Pediatrics Rehabilitation medicine Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine anticipatory and compensatory postural adjustments (APAs and CPAs, respectively) during voluntary movement while standing in individuals with bilateral spastic cerebral palsy.
Basic objectives2 Others
Basic objectives -Others To examine stance balance control in individuals with BSCP.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postural muscle activities and center of pressure.
Key secondary outcomes

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
12 years-old <
Age-upper limit
23 years-old >=
Gender Male and Female
Key inclusion criteria BSCP group: level II or III of the Gross Motor Function Classification System; control group: no history of neurological or orthopedic impairment.
Key exclusion criteria BSCP group: no surgical procedures within 2 years prior to participation; and no history of any genetic or neurological disorder other than BSCP.
Target sample size 21

Research contact person
Name of lead principal investigator
1st name Hidehito
Middle name
Last name Tomita
Organization Toyohashi SOZO University
Division name Graduate School of Health Sciences
Zip code 440-8511
Address 20-1 Matsushita, Ushikawa-cho, Toyohashi, Japan
TEL 050-2017-2277
Email h_tomita@sozo.ac.jp

Public contact
Name of contact person
1st name Hidehito
Middle name
Last name Tomita
Organization Toyohashi SOZO University
Division name Graduate School of Health Sciences
Zip code 440-8511
Address 20-1 Matsushita, Ushikawa-cho, Toyohashi, Japan
TEL 050-2017-2277
Homepage URL
Email h_tomita@sozo.ac.jp

Sponsor
Institute Toyohashi SOZO University
Institute
Department

Funding Source
Organization JSPS KAKENHI [Grant Number JP 21700554]
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Ethics Committee at Toyohashi SOZO University
Address 20-1 Matsushita, Ushikawa-cho, Toyohashi, Japan
Tel 050-2017-2277
Email h_tomita@sozo.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
2020 Year 02 Month 17 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 21
Results Participants with BSCP exhibited weaker APAs and were more dependent on CPAs during load lifting task while standing, although their CPAs were insufficient to adequately reduce the negative effects of their APA deficits, which is likely to result in a larger disturbance of postural equilibrium during voluntary movement while standing.
Results date posted
2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 7 individuals with GMFCS level II BSCP (3 females and 4 males, 12-22 years), 7 individuals with GMFCS level III BSCP (3 females and 4 males, 12-23 years), and 7 individuals without disability (3 females and 4 males, 12-22 years).
Participant flow Participants were recruited at a pediatric rehabilitation center.
Adverse events None
Outcome measures Postural muscle activities in the trunk and lower limbs, and center of pressure.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 28 Day
Date of IRB
2009 Year 07 Month 28 Day
Anticipated trial start date
2009 Year 08 Month 07 Day
Last follow-up date
2011 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Postural muscle activities during load lifting task were compared between individuals with and without bilateral spastic cerebral palsy.

Management information
Registered date
2020 Year 02 Month 17 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/02/17 All results.xlsx


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