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Trial registered on ANZCTR
Registration number
ACTRN12624000481572
Ethics application status
Approved
Date submitted
25/01/2024
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Activities of back and leg muscles during one-legged standing balance
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Scientific title
Comparative electromyographic analysis of lumbopelvic and leg muscles during single-leg stance among individuals with chronic ankle instability, recovered from ankle instability and healthy adults
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Secondary ID [1]
311418
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic ankle instability
332700
0
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Ankle rehabilitation
333215
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Condition category
Condition code
Musculoskeletal
329413
329413
0
0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
329902
329902
0
0
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Other physical medicine / rehabilitation
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Injuries and Accidents
329903
329903
0
0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Participants with chronic ankle instability will be observed for bilateral muscle activities. The total duration of the study is estimated to take 1 hour. The study investigators will put electrodes on some muscle groups in the lower limb and back to measure muscle activity. You may be required to shave the area under the electrodes if it interferes with the EMG signals or if it prevents adherence of the EMG electrodes to the skin.
Participants will perform muscle strength tests for the lower back and lower limbs to determine maximal muscle activity. Participants will perform 3 trials of 5 seconds holds against manual resistance for each muscle group on both sides during the muscle strength testing with a minimum of 2 minutes rest between trials to prevent fatigue.
Following that, participants will practice 4 single-leg stand (SLS) trials. These trials entail standing on each leg for a duration of 10 seconds, first on a stable surface and then on a foam surface. A rest period of 60 seconds will be provided between each practice trial.
After the 60 seconds break, participants will perform the SLS tests on a stable surface. Participants will perform 3 tests of 10s on each leg, starting with dominant leg. Rests of 60 seconds will be provided between each test.
Subsequently, the SLS test procedures are repeated on an unstable surface (foam platform). Rests of 60 seconds will be provided between each test.
Assessments by study investigators:
1. Maximal Voluntary Isometric Contraction (MVIC) also known as muscle strength testing
2. SLS trial/test
Surface Electromyography (sEMG) placement by study investigators:
- Surface EMG markers will be placed at specific parts of the lower back and legs to measure muscle activity of longissimus dorsi, gluteus medius and maximus, vastus lateralis, tibialis anterior, peroneus longus and gastronemius medialis muscle groups;
- Skin may be lightly shaved and wiped with alcohol to reduce interelectrode resistance prior to electrode placement.
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Intervention code [1]
327857
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Not applicable
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Comparator / control treatment
Participants with no ankle injury (healthy) and participants who recovered from ankle instability serve as control groups in this study. The total duration of the study is estimated to take 1 hour. The study investigators will put electrodes on some muscle groups in the lower limb and back to measure muscle activity. You may be required to shave the area under the electrodes if it interferes with the EMG signals or if it prevents adherence of the EMG electrodes to the skin.
Participants will perform muscle strength tests for the lower back and lower limbs to determine maximal muscle activity. Participants will perform 3 trials of 5 seconds holds against manual resistance for each muscle group on both sides during the muscle strength testing with a minimum of 2 minutes rest between trials to prevent fatigue.
Following that, participants will practice 4 SLS trials. These trials entail standing on each leg for a duration of 10 seconds, first on a stable surface and then on a foam surface. A rest period of 60 seconds will be provided between each practice trial.
After the 60 seconds break, participants will perform the SLS tests on a stable surface. Participants will perform 3 tests of 10s on each leg, starting with dominant leg. Rests of 60 seconds will be provided between each test.
Subsequently, the SLS test procedures are repeated on an unstable surface (foam platform). Rests of 60 seconds will be provided between each test.
Assessments by study investigators:
1. Maximal Voluntary Isometric Contraction (MVIC) also known as muscle strength testing
2. SLS trial/test
Surface Electromyography (sEMG) placement by study investigators:
- Surface EMG markers will be placed at specific parts of the lower back and legs to measure muscle activity of longissimus dorsi, gluteus medius and maximus, vastus lateralis, tibialis anterior, peroneus longus and gastronemius medialis muscle groups;
- Skin may be lightly shaved and wiped with alcohol to reduce interelectrode resistance prior to electrode placement.
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Control group
Active
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Outcomes
Primary outcome [1]
337228
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Gluteus medius muscle activity
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Assessment method [1]
337228
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Surface electromyography
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Timepoint [1]
337228
0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Primary outcome [2]
337229
0
Longissimus dorsi muscle activity
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Assessment method [2]
337229
0
Surface electromyography
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Timepoint [2]
337229
0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Secondary outcome [1]
431125
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Gluteus maximus muscle activity
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Assessment method [1]
431125
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Surface electromyography
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Timepoint [1]
431125
0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Secondary outcome [2]
431126
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Tibialis anterior muscle activity
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Assessment method [2]
431126
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Surface electromyography
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Timepoint [2]
431126
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Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Secondary outcome [3]
431127
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Peroneus longus muscle activity
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Assessment method [3]
431127
0
Surface electromyography
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Timepoint [3]
431127
0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Secondary outcome [4]
431128
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Vastus lateralis muscle activity
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Assessment method [4]
431128
0
Surface electromyography
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Timepoint [4]
431128
0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Secondary outcome [5]
431129
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Medial gastrocnemius muscle activity
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Assessment method [5]
431129
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Surface electromyography
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Timepoint [5]
431129
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Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
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Eligibility
Key inclusion criteria
All participants: Proficient in spoken and written English language and able to perform single-leg stand without support.
Healthy participant study arm: No previous lower limb surgery and/or fracture in their lifetime, and no history of ankle sprain.
Recovered participant study arm: A history of at least one acute unilateral ankle sprain and no difficulty reported in the Foot and Ankle Ability Measure activities of daily living questionnaire (FAAM)
Chronic ankle instability study arm:
- A history of at least two acute unilateral ankle sprains but no previous lower limb surgery and/or fracture in their lifetime;
- A history of at least two giving way episodes within the past 6 months; AND
- Any slight difficulty in the Foot and Ankle Ability Measure (FAAM) activities of daily living (ADL) questionnaire.
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Minimum age
21
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Long-term use of medications that may cause dizziness, vertigo symptoms;
- Any skin allergy;
- History of neurological deficits; OR
- History of fracture and/or surgery in the lower limb.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
48
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26117
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Singapore
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State/province [1]
26117
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Funding & Sponsors
Funding source category [1]
315680
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University
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Name [1]
315680
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Singapore Institute of Technology
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Address [1]
315680
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Country [1]
315680
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Singapore
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Primary sponsor type
University
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Name
Singapore Institute of Technology
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Address
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Country
Singapore
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Secondary sponsor category [1]
317786
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Commercial sector/Industry
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Name [1]
317786
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Clinical Pilates Family Physiotherapy
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Address [1]
317786
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Country [1]
317786
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Singapore
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314558
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Singapore Institute of Technology - Institutional Review Board
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Ethics committee address [1]
314558
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10 Dover Dr, Singapore 138683, Singapore
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Ethics committee country [1]
314558
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Singapore
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Date submitted for ethics approval [1]
314558
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24/01/2024
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Approval date [1]
314558
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21/03/2024
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Ethics approval number [1]
314558
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RECAS-0267
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Summary
Brief summary
Primarily, our study aims to investigate the difference between bilateral gluteus medius and longissimus dorsi muscle activity during single-leg stance (SLS) on stable and unstable surfaces. We hypothesize that the non-stance side will have a higher muscle activation than the stance side on both surfaces.
Secondly, this study aims to compare the muscle activation in both lower limbs and back when performing SLS on an unstable surface on the dominant and non-dominant leg between healthy adults, adults who recovered from ankle instability and adults with existing chronic ankle instability. There is insufficient evidence to conclude the effect of leg dominance on postural balance during SLS and balance performance relies largely on environmental and individual context such as methods of the data collection and physiological difference between individuals. We hypothesise that healthy adults and those who recovered from ankle instability will not show significant difference in muscle activation on both sides when standing on the dominant or non-dominant leg. We also hypothesise that CI will have higher muscle activation on both sides when standing on the injured leg compared to the uninjured leg when maintaining SLS.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
132006
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Mr Kwok Boon Chong
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Address
132006
0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
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Country
132006
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Singapore
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Phone
132006
0
+65 65922901
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Fax
132006
0
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Email
132006
0
[email protected]
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Contact person for public queries
Name
132007
0
Kwok Boon Chong
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Address
132007
0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
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Country
132007
0
Singapore
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Phone
132007
0
+65 65922901
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Fax
132007
0
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Email
132007
0
[email protected]
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Contact person for scientific queries
Name
132008
0
Kwok Boon Chong
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Address
132008
0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
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Country
132008
0
Singapore
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Phone
132008
0
+65 65922901
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Fax
132008
0
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Email
132008
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Local personal data protection act restriction.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21868
Study protocol
387237-(Uploaded-13-03-2024-17-03-23)-Study-related document.pdf
22226
Ethical approval
387237-(Uploaded-18-04-2024-11-36-24)-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.
Download to PDF