ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621001142820

Ethics application status

Approved

Date submitted

29/07/2020

Date registered

24/08/2021

Date last updated

19/09/2023

Date data sharing statement initially provided

24/08/2021

Date results provided

19/09/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of clinical strength testing and perception of participant with regards to their strength in performing Clamshell exercise in various hip bend positions among healthy adults.

Scientific title

Accuracy and Reliability of Manual Muscle Testing and Subjective Feedback to Identify Optimal Hip Flexion Angle for Clamshell Exercise in Healthy Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hip muscle strength

Condition category

Condition code

Musculoskeletal

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 (EMG) data of gluteus maximus, gluteus medius and tensor fascia latae (TFL) muscles will be collected from both of the participants’ legs. Alcohol swabs are used to clean the skin over the gluteal and hip region before placement of the Delsys’s surface EMG electrodes according to recommended protocols by Rainoldi and colleagues in 2004. The surface EMG electrodes used in this study are wireless and will only have the 3 electrodes placed per side. To measure gluteus medius muscle activity, the electrode will be placed one-third of the distance between the greater trochanter and the iliac crest, the electrode measuring gluteus maximus muscle activity will be placed one-third of the distance between second sacral vertebra and greater trochanter and the electrode measuring TFL will be placed 75mm from the anterior superior iliac spine, along a line-oriented 30° anterior to the line joining the anterior superior iliac spine and the greater trochanter.
Participants' maximal voluntary isometric contraction (MVIC) of the muscles will be tested. MVIC of gluteus maximus muscle will be tested in prone lying with knees flexed to 90° while participants perform resisted hip extension while MVIC of gluteus medius muscle will be tested in side-lying with hips and knees extended at 0° while participants perform resisted hip abduction to 30°, while MVIC testing for TFL is similar but with addition of 45° hip flexion.
Next, participants will be instructed to lie on their side on a plinth with their legs together, hips and knees flexed and a pillow supporting their head and neck with their arms by the side. They will be instructed to keep the medial borders of their feet together as they try to abduct and externally rotate their hips. They will be required to practice the exercise at each angle until their technique and execution are deemed as satisfactory with no compensatory actions eg. trunk rotation. Participants will be monitored to ensure their pelvis is maintained in the neutral position as it aids in optimising gluteal muscle recruitment during the clamshell exercise. Once the practice trials are completed, participants would be given 5 minutes to rest before the commencement of the study.
Participants will be required to perform four variants of the clamshell exercise at hip angle 0° followed by 30°, 60° and 90°. They will first be shown a demonstration of the clamshell exercise at the four angles tested: 0°, 30°, 60° and 90°. Before each test, hip flexion angle of participants will be adjusted with the use of a goniometer. Next, knee flexion angle is maintained at 90°. A researcher will perform manual muscle testing (MMT) of the hip muscles in the clamshell exercise at each of the hip angles before MVIC testing. MMT will be done in accordance with Medical Research Council Manual Muscle Testing and the researcher will grade the strength accordingly. Next, participants will need to perform three consecutive 5 seconds MVIC at each hip angle with 3 minutes rest in between each test angle. A luggage belt will be strapped around the plinth and the lateral condyle of participants’ femur to ensure standardization. At the end of the tests, participants will be asked to rank the angles in which they felt was the strongest to weakest in performing the clamshell exercise.
The approximate total duration of the testing session is 60 minutes. Participant will attend the session once. A registered physiotherapist will monitor and recommend adjustment to the positioning of the participant.

Intervention code [1]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

MVIC of gluteus medius muscle during 5-second clamshell exercise measured using non-invasive EMG.

Timepoint [1]

Baseline

Secondary outcome [1]

MVIC of gluteus maximus muscle during 5-second clamshell exercise measured using non-invasive EMG.

Timepoint [1]

Baseline

Secondary outcome [2]

MVIC of tensor fascia latae muscle during 5-second clamshell exercise measured using non-invasive EMG.

Timepoint [2]

Baseline

Secondary outcome [3]

Participant's perceived strongest hip abduction force out of the 4 hip flexion angle to perform the clamshell exercise, ie. 0, 30, 60 or 90 degrees hip flexion using ranking of 1 (strongest) to 4 (weakest).

Timepoint [3]

Baseline

Secondary outcome [4]

Assessor's perceived strongest force produced by the participant out of the 4 hip flexion angle during the clamshell exercise using MMT technique.

Timepoint [4]

Baseline

Eligibility

Key inclusion criteria

Healthy English speaking participants with no skin allergies above the age of 21 currently without low back pain, hip or knee injuries or pathologies.

Minimum age

21 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Presence of lower extremity co-morbidities, Body Mass Index (BMI) > 25.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Random sample

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

20/07/2020

Date of last participant enrolment

Anticipated

Actual

30/12/2020

Date of last data collection

Anticipated

Actual

30/12/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Singapore

State/province [1]

Not applicable

Funding & Sponsors

Funding source category [1]

University

Name [1]

Singapore Institute of Technology

Address [1]

10 Dover Dr, Singapore 138683

Country [1]

Singapore

Primary sponsor type

University

Name

Singapore Institute of Technology

Address

10 Dover Dr, Singapore 138683

Country

Singapore

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Singapore Institute of Technology Institutional Review Board

Ethics committee address [1]

10 Dover Dr, Singapore 138683

Ethics committee country [1]

Singapore

Date submitted for ethics approval [1]

Approval date [1]

13/07/2020

Ethics approval number [1]

Summary

Brief summary

Weakness of hip musculature, especially the hip abductors, has been associated with increased risk of low back pain and lower extremity injuries, both of which are increasingly prevalent with significant impacts. Ensuring adequate hip muscle strength can aid in reducing the likelihood of developing the aforementioned injuries. The clamshell exercise, although commonly prescribed to strengthen the hip abductors and performed in 45° to 60° hip flexion, the angles may not be specific for optimal muscle activation between individuals. Existing literature has shown that finding the right position is not only important to enable greater improvements in function but also to prevent the detrimental effects that may result from executing the exercises in positions not suited for the individual. Therefore, this study investigates the ideal position that elicits the optimal activation of gluteal muscle activation during the clamshell exercise. We will aim to determine the accuracy/reliability of using Manual Muscle Testing and an individual’s subjective feedback in identifying the position in which participants have greatest activation of their gluteal muscles. 
Subjective feedback, Manual Muscle Testing scores, Electromyography readings, and Maximal Voluntary Isometric Contractions will be used to aid in determining the ideal clamshell position to elicit optimal gluteal muscle activation. The clamshell exercise in 0° hip flexion places the back in extension, enabling the assessment of the influence of an extension preference. Conversely, 30°, 60° or 90° hip flexion places the back in different amounts of flexion and would enable the assessment of flexion preference on gluteal muscle activation.
We hypothesise that the ideal clamshell position which elicits optimal activation of the gluteal muscles varies for each individual and that the methods tested to identify the ideal position are reliable and accurate. These findings would guide in the prescription of clamshell exercises specific to an individual and in community-based exercise programmes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Boon Chong Kwok

Address

150A Mei Chin Road #02-01 S140150
Thye Hua Kwan Moral Charities Ltd

Country

Singapore

Phone

+65 64714290

Fax

kwokboonchong@thkmc.org.sg

Contact person for public queries

Name

Boon Chong Kwok

Address

150A Mei Chin Road #02-01 S140150
Thye Hua Kwan Moral Charities Ltd

Country

Singapore

Phone

+65 64714290

Fax

kwokboonchong@thkmc.org.sg

Contact person for scientific queries

Name

Boon Chong Kwok

Address

150A Mei Chin Road #02-01 S140150
Thye Hua Kwan Moral Charities Ltd

Country

Singapore

Phone

+65 64714290

Fax

kwokboonchong@thkmc.org.sg

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

PDPA guidelines of local authorities restrict individual participant data disclosure.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8636	Ethical approval					380287-(Uploaded-29-07-2020-12-35-07)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically