UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030141 |
|---|---|
| Receipt number | R000034426 |
| Scientific Title | The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2018/03/08 05:05:24 |
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Basic information
Public title
The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study
Acronym
Effects of Manual Therapy and Exercises on Forward Head and Rounded Shoulder Posture
Scientific Title
The Effect of Manual Therapy and Stabilizing Exercises on Forward Head and Rounded Shoulder Postures: a six-week intervention with a one-month follow-up study
Scientific Title:Acronym
Effects of Manual Therapy and Exercises on Forward Head and Rounded Shoulder Posture
Region
| Asia(except Japan) |
Condition
Condition
Forward Head and Rounded Shoulder Posture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a six-week neck manual therapy plus stabilizing exercise, and one-month following, on forward head and round shoulder posture
Basic objectives2
Others
Basic objectives -Others
Differences between experimental groups and the control group
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posture; Pain; Function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Stabilizing Exercise; three sessions per week for six weeks
Interventions/Control_2
Manual interventions; three sessions per week for six weeks
Interventions/Control_3
Control; 3-time home exercise program weekly described postural correction on daily activities
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
| 32 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
Cervical (CA > 46 degrees) and shoulder (SA > 52 degrees) angle measured with photogrammetry. The neck pain should be between three and eight based on visual analog scale and at least within the last three months.
Key exclusion criteria
Exclusion criteria were a history of cervical spine injury or surgery, neck pain secondary to other conditions (including neoplasm, neurological diseases or vascular diseases), a neurological deficit, infection, or inflammatory arthritis in the cervical spine, receiving physiotherapy within the last 6 months, and poor general health status that would interfere with the exercises over the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maliheh Haddadnezhad |
Organization
Kharazmi University
Division name
Faculty of Physical Education and Sport Sciences
Zip code
Address
Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj
TEL
00989123469464
m.hadadnezhad@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiana Fatholahnezhad |
Organization
Kharazmi University
Division name
Faculty of Physical Education and Sport Sciences
Zip code
Address
Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj
TEL
00989132950114
Homepage URL
fkianaz@gmail.com
Sponsor or person
Institute
Kharazmi University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
| 2018 | Year | 03 | Month | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034426
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
