UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053560 |
|---|---|
| Receipt number | R000061118 |
| Scientific Title | Determining the impact and sustainability of the dynamic neuromuscular stabilization exercise program on physical fitness factors related to the health of mentally disabled adults |
| Date of disclosure of the study information | 2024/03/24 |
| Last modified on | 2024/02/07 04:01:06 |
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Basic information
Public title
Determining the impact and sustainability of the dynamic neuromuscular stabilization exercise program on physical fitness factors related to the health of mentally disabled adults
Acronym
Determining the impact and sustainability of the dynamic neuromuscular stabilization exercise program on physical fitness factors related to the health of mentally disabled adults
Scientific Title
Determining the impact and sustainability of the dynamic neuromuscular stabilization exercise program on physical fitness factors related to the health of mentally disabled adults
Scientific Title:Acronym
Determining the impact and sustainability of the dynamic neuromuscular stabilization exercise program on physical fitness factors related to the health of mentally disabled adults
Region
| Asia(except Japan) |
Condition
Condition
pretesr-posttest
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determining the impact and sustainability of the dynamic neuromuscular stabilization exercise program on physical fitness factors related to the health of mentally disabled adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Static and dynamic balance, coordination
Key secondary outcomes
Cardiorespiratory endurance, muscular strength and endurance, flexibility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Dynamic neuromuscular stabilization exercise
Interventions/Control_2
Control
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
| 30 | years-old | < |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
Placement in the learnable group with an IQ of 50 to 70
No use of nerve drugs or drugs affecting balance
Having no history of musculoskeletal disorders and lower limb injury and surgery during the past year
Not having any disease in the vestibular system and not having a cochlear implant
No visual impairment
having normal vision without wearing glasses and the desire and ability to participate in the test, as well as the satisfaction of the family and the person himself.
Key exclusion criteria
Absence in two consecutive sessions or three non-consecutive sessions during the study is unwillingness to continue the research or observing disability to the extent that the person is unable to perform exercises.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hamed |
| Middle name | |
| Last name | Babgoltabar Samakoush |
Organization
Mazandaran University
Division name
Sport
Zip code
00989114581408
Address
Mazandaran-Babolsar-Pasdaran Street-postal code 57447-47419
TEL
00989114581408
Hb.sama@yahoo.com
Public contact
Name of contact person
| 1st name | Hamed |
| Middle name | |
| Last name | Babgoltabar Samakoush |
Organization
Mazandaran University
Division name
Sport
Zip code
00989114581408
Address
Mazandaran-Babolsar-Pasdaran Street-postal code 57447-47419
TEL
00989114581408
Homepage URL
Hb.sama@yahoo.com
Sponsor or person
Institute
Self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Shahrood University of Technology
Address
Shahrood - Haft Tir Square - Shahrood University of Technology
Tel
00989114581408
Hb.sama@yahoo.com
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 | 03 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 16 | 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 | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061118
