Trial Review

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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 information initially provided
24/08/2021
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] 301911 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip muscle strength 318427 0
Condition category
Condition code
Musculoskeletal 316433 316433 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 (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] 318196 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324585 0
MVIC of gluteus medius muscle during 5-second clamshell exercise measured using non-invasive EMG.
Timepoint [1] 324585 0
Baseline
Secondary outcome [1] 385086 0
MVIC of gluteus maximus muscle during 5-second clamshell exercise measured using non-invasive EMG.
Timepoint [1] 385086 0
Baseline
Secondary outcome [2] 385087 0
MVIC of tensor fascia latae muscle during 5-second clamshell exercise measured using non-invasive EMG.
Timepoint [2] 385087 0
Baseline
Secondary outcome [3] 398923 0
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] 398923 0
Baseline
Secondary outcome [4] 398924 0
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] 398924 0
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
34
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 22800 0
Singapore
State/province [1] 22800 0
Not applicable

Funding & Sponsors
Funding source category [1] 306326 0
University
Name [1] 306326 0
Singapore Institute of Technology
Country [1] 306326 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Dr, Singapore 138683
Country
Singapore
Secondary sponsor category [1] 306822 0
None
Name [1] 306822 0
Address [1] 306822 0
Country [1] 306822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306537 0
Singapore Institute of Technology Institutional Review Board
Ethics committee address [1] 306537 0
10 Dover Dr, Singapore 138683
Ethics committee country [1] 306537 0
Singapore
Date submitted for ethics approval [1] 306537 0
Approval date [1] 306537 0
13/07/2020
Ethics approval number [1] 306537 0

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 104206 0
Mr Boon Chong Kwok
Address 104206 0
150A Mei Chin Road #02-01 S140150
Thye Hua Kwan Moral Charities Ltd
Country 104206 0
Singapore
Phone 104206 0
+65 64714290
Fax 104206 0
Email 104206 0
[email protected]
Contact person for public queries
Name 104207 0
Mr Boon Chong Kwok
Address 104207 0
150A Mei Chin Road #02-01 S140150
Thye Hua Kwan Moral Charities Ltd
Country 104207 0
Singapore
Phone 104207 0
+65 64714290
Fax 104207 0
Email 104207 0
[email protected]
Contact person for scientific queries
Name 104208 0
Mr Boon Chong Kwok
Address 104208 0
150A Mei Chin Road #02-01 S140150
Thye Hua Kwan Moral Charities Ltd
Country 104208 0
Singapore
Phone 104208 0
+65 64714290
Fax 104208 0
Email 104208 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
8636Ethical approval    380287-(Uploaded-29-07-2020-12-35-07)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 25/8/2023, Pre-proof Lim, E. A. Y. Y., Yeo, R. Y.... [More Details]

Documents added automatically
No additional documents have been identified.