Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000253404
Ethics application status
Approved
Date submitted
18/02/2016
Date registered
24/02/2016
Date last updated
27/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring shoulder muscle activity levels during low-intensity exercise in asymptomatic individuals
Scientific title
Shoulder muscle activity during the modified dynamic relocation test and side-lying shoulder external rotation: a cross-sectional study on asymptomatic individuals
Secondary ID [1] 288575 0
None
Universal Trial Number (UTN)
U1111-1179-8565
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder disorders 297707 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297895 297895 0 0
Physiotherapy
Musculoskeletal 297915 297915 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Electromyography
Wireless surface electromyography (EMG) electrodes will be placed on three rotator cuff muscles (supraspinatus, infraspinatus), deltoid (anterior, middle and posterior heads), pectoralis major, and latissimus dorsi muscles according to the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) guidelines.. Prior to electrode placement, the skin area will be shaved and cleaned with an alcohol swab. EMG data will be sampled at 1000 Hz. Prior to performing the shoulder exercises, the maximal voluntary contraction will be tested for each of the analysed muscles, following the SENIAM guidelines.
Procedures
Data collection will last for 45 min. Shoulder muscle activity levels were monitored with the EMG while participants performed the exercises.
Firstly, participants will be screened for shoulder disorders. Then, participants’ age, height and weight will be recorded. Next, participants will be asked to perform 10 repetitions for each the two shoulder exercises: (1) the relocation shoulder exercise; (2) shoulder external rotation.
The relocation exercise
The researcher gently pulls the arm longitudinally, while the patient is requested to counter-act this by pulling the arm back. The patient sustains an isometric contraction for 3 seconds.
Shoulder external rotation
This exercise consists of rotating the shoulder laterally, while side-lying with a flexed elbow with the arm close to the trunk. This exercise has been shown to encourage recruitment of shoulder external rotator muscles, including Infraspinatus and Supraspinatus.
Intervention code [1] 293967 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297411 0
The mean muscle activity and its 95% confidence interval will be calculated for each muscle, and will be expressed as % of the MVIC.
Timepoint [1] 297411 0
We monitored muscle activity levels during shoulder exercises, over the ten repetitions of each exercise..
Secondary outcome [1] 320978 0
Nil.
Timepoint [1] 320978 0
N/A

Eligibility
Key inclusion criteria
Participants will be included if they present no current neck and shoulder injuries.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they present any positive response to the cervical and shoulder screening tests.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/01/2014
Date of last participant enrolment
Anticipated
Actual
24/02/2015
Date of last data collection
Anticipated
Actual
24/02/2015
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7604 0
New Zealand
State/province [1] 7604 0
Dunedin

Funding & Sponsors
Funding source category [1] 292923 0
Charities/Societies/Foundations
Name [1] 292923 0
Jack Thomson Grant - Otago Medical Research Foundation
Country [1] 292923 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street, 9054
Postcode: PO Box 56
Dunedin
Country
New Zealand
Secondary sponsor category [1] 291679 0
None
Name [1] 291679 0
Address [1] 291679 0
Country [1] 291679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294428 0
University of Otago Ethics Committee
Ethics committee address [1] 294428 0
University of Otago Council
PO Box 56
Dunedin 9054
New Zealand
Ethics committee country [1] 294428 0
New Zealand
Date submitted for ethics approval [1] 294428 0
01/10/2013
Approval date [1] 294428 0
01/11/2013
Ethics approval number [1] 294428 0
13/253

Summary
Brief summary
Shoulder disorders is a debilitating condition impacting daily living activities. Shoulder exercises are currently recommended at early stages of rehabilitation. Recent studies, however, suggest little evidence for shoulder exercise as an effective intervention for improving function and reducing pain. Before designing and testing new interventions for shoulder disorders, it is important to identify whether these exercises optimize shoulder muscle activity. This study aims to quantify shoulder muscle activity during selected shoulder exercises.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63674 0
Dr Daniel Cury Ribeiro
Address 63674 0
School of Physiotherapy - University of Otago
325 Great King Street, 9054
Postcode: PO Box 56,
Dunedin
Country 63674 0
New Zealand
Phone 63674 0
+64 3 479 7455
Fax 63674 0
Email 63674 0
[email protected]
Contact person for public queries
Name 63675 0
Daniel Cury Ribeiro
Address 63675 0
School of Physiotherapy - University of Otago
325 Great King Street, 9054
Postcode: PO Box 56,
Dunedin
Country 63675 0
New Zealand
Phone 63675 0
+6434797455
Fax 63675 0
Email 63675 0
[email protected]
Contact person for scientific queries
Name 63676 0
Daniel Cury Ribeiro
Address 63676 0
School of Physiotherapy - University of Otago
325 Great King Street, 9054
Postcode: PO Box 56,
Dunedin
Country 63676 0
New Zealand
Phone 63676 0
+6434797455
Fax 63676 0
Email 63676 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIShoulder muscle activity during the modified dynamic relocation test and side-lying shoulder external rotation: a cross-sectional study on asymptomatic individuals2016https://doi.org/10.1080/10669817.2016.1157945
N.B. These documents automatically identified may not have been verified by the study sponsor.