UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031611
Receipt number R000036041
Scientific Title Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome
Date of disclosure of the study information 2018/05/09
Last modified on 2018/05/09 23:01:21

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Basic information

Public title

Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome

Acronym

The effects of Sensorimotor training programs in patients with Scapular Downward Rotation Syndrome

Scientific Title

Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome

Scientific Title:Acronym

The effects of Sensorimotor training programs in patients with Scapular Downward Rotation Syndrome

Region

Asia(except Japan)


Condition

Condition

Scapular Downward Rotation Syndrome

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the effects of six weeks sensorimotor training and sensorimotor plus passive interventions program on pain, electrical activity of selected scapular muscles and kinematics in people with scapular downward rotation syndrome (SDRS)

Basic objectives2

Others

Basic objectives -Others

To evaluate the differences between intervention programs

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain, electrical activity of selected scapular muscles and kinematics.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Intervention 1: 6-week sensorimotor training program; 3 sessions per week (1 hour each session

Interventions/Control_2

Intervention 2: 6-week sensorimotor plus Passive Interventions program; 3 sessions per week (1 hour each session)

Interventions/Control_3

Control group; total of 3 hours per week home exercise program 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

20 years-old <=

Age-upper limit

27 years-old >=

Gender

Male

Key inclusion criteria

The inclusion criteria were: (1) the downwardly rotated scapula (the inferior angle moves medially, and the glenoid fossa rotates to face caudally); (2) the acromioclavicular joint lower than the sternoclavicular joint; (3) the vertebral border of the scapula less than 3 inches from the spine with tape measure (measured from the midpoint of the vertebral border of the scapula to the corresponding thoracic spinous process); (4) previous history of neck pain at least for 6 weeks; and (5) VAS score at rest between 3 and 7 (severe pain).

Key exclusion criteria

Subjects with cervical spinal fractures, neck rotation ROM of < 20 degrees, radiating pain to the upper extremity, history of unresolved cancer, neurological disorders and subjects with severe musculoskeletal disorders were excluded. Subjects were also excluded if they missed practice for three consecutive sessions or more due to neck or shoulder pain.

Target sample size

132


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Amir Letafatkar

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code


Address

Faculty of Physical Education, Kharazmi University, South Hesari St., Mirdamad Blvd., Tehran

TEL

00989357365993

Email

amir.letafatkar@khu.ac.ir


Public contact

Name of contact person

1st name
Middle name
Last name Alireza Derakhshani

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code


Address

Faculty of Physical Education, Kharazmi University, South Hesari St., Mirdamad Blvd., Tehran

TEL

00989364331192

Homepage URL


Email

std_alireza.derakhshani@khu.ac.ir


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


Email



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 05 Month 09 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

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 12 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

2018 Year 03 Month 06 Day

Last modified on

2018 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036041


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name