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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
15/09/2024
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
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
Secondary ID [1] 311418 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic ankle instability 332700 0
Ankle rehabilitation 333215 0
Condition category
Condition code
Musculoskeletal 329413 329413 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 329902 329902 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 329903 329903 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 327857 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 337228 0
Gluteus medius muscle activity
Timepoint [1] 337228 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
Primary outcome [2] 337229 0
Longissimus dorsi muscle activity
Timepoint [2] 337229 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
Secondary outcome [1] 431125 0
Gluteus maximus muscle activity
Timepoint [1] 431125 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
Secondary outcome [2] 431126 0
Tibialis anterior muscle activity
Timepoint [2] 431126 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
Secondary outcome [3] 431127 0
Peroneus longus muscle activity
Timepoint [3] 431127 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
Secondary outcome [4] 431128 0
Vastus lateralis muscle activity
Timepoint [4] 431128 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance
Secondary outcome [5] 431129 0
Medial gastrocnemius muscle activity
Timepoint [5] 431129 0
Baseline - assessed continuously for 10 secs during stable and unstable single leg stance

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.
Minimum age
21 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2024
Actual
22/04/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
7/08/2024
Date of last data collection
Anticipated
31/12/2024
Actual
7/08/2024
Sample size
Target
48
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 26117 0
Singapore
State/province [1] 26117 0

Funding & Sponsors
Funding source category [1] 315680 0
University
Name [1] 315680 0
Singapore Institute of Technology
Country [1] 315680 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
Country
Singapore
Secondary sponsor category [1] 317786 0
Commercial sector/Industry
Name [1] 317786 0
Clinical Pilates Family Physiotherapy
Address [1] 317786 0
Country [1] 317786 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314558 0
Singapore Institute of Technology - Institutional Review Board
Ethics committee address [1] 314558 0
Ethics committee country [1] 314558 0
Singapore
Date submitted for ethics approval [1] 314558 0
24/01/2024
Approval date [1] 314558 0
21/03/2024
Ethics approval number [1] 314558 0
RECAS-0267

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132006 0
Mr Kwok Boon Chong
Address 132006 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
Country 132006 0
Singapore
Phone 132006 0
+65 65922901
Fax 132006 0
Email 132006 0
[email protected]
Contact person for public queries
Name 132007 0
Kwok Boon Chong
Address 132007 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
Country 132007 0
Singapore
Phone 132007 0
+65 65922901
Fax 132007 0
Email 132007 0
[email protected]
Contact person for scientific queries
Name 132008 0
Kwok Boon Chong
Address 132008 0
10 Dover Dr, Singapore Institute of Technology, Singapore 138683
Country 132008 0
Singapore
Phone 132008 0
+65 65922901
Fax 132008 0
Email 132008 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
Local personal data protection act restriction.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21868Study protocol    387237-(Uploaded-13-03-2024-17-03-23)-Study-related document.pdf
22226Ethical 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.