UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039511 |
|---|---|
| Receipt number | 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 15:46:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
h_tomita@sozo.ac.jp
Sponsor or person
Institute
Toyohashi SOZO University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
