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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05687955
Registration number
NCT05687955
Ethics application status
Date submitted
4/01/2023
Date registered
18/01/2023
Titles & IDs
Public title
Exercise Rehabilitation for Hip-related Pain and Dysfunction in Student Circus Arts Performers
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Scientific title
Exercise Rehabilitation for Hip-related Pain and Dysfunction in Full Time Student Circus Arts Performers: a Pilot Trial
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Secondary ID [1]
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SwinburneUT
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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:
Hip Dysplasia
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Femoro Acetabular Impingement
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Hip Exercise Program
Experimental: Hip Exercise Program - A 12-week strength exercise protocol has been specifically designed to focus on hip rehabilitation appropriate for circus performance.
Other interventions: Hip Exercise Program
The exercise intervention is being implemented 3 times per week. Two sessions can be completed at home by the participant, and one session per week will be attended by a physiotherapist that will monitor exercise technique and progress the exercise program for each participant. The exercise protocol has been specifically designed to focus on hip rehabilitation appropriate for circus performance. The exercise program will involve hip strength exercises in the sagittal, coronal and transverse planes using weights and elastic bands (Theraband). It will also include trunk strength and postural correction exercises to address swayback posture which is a common clinical presentation in those with hip dysplasia.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Copenhagen Hip and Groin Outcome Score (HAGOS)
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Assessment method [1]
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Patient Reported Outcome Measure, score on 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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The Copenhagen Hip and Groin Outcome Score (HAGOS)
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Assessment method [2]
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Patient Reported Outcome Measure, score on 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems.
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Timepoint [2]
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3-months
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Primary outcome [3]
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The Copenhagen Hip and Groin Outcome Score (HAGOS)
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Assessment method [3]
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Patient Reported Outcome Measure, score on 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems.
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Timepoint [3]
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6-months
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Primary outcome [4]
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The Copenhagen Hip and Groin Outcome Score (HAGOS)
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Assessment method [4]
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Patient Reported Outcome Measure, score on 0-100 scale, with zero representing extreme hip and/or groin problems and 100 representing no hip and/or groin problems.
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Timepoint [4]
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9-months
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Primary outcome [5]
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International Hip Outcome Tool (iHOT-12)
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Assessment method [5]
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Patient Reported Outcome Measure, scored using a visual analog scale from 0 to 100, with a score of 100 being the best function and least amount of symptoms
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Timepoint [5]
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Baseline
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Primary outcome [6]
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International Hip Outcome Tool (iHOT-12)
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Assessment method [6]
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Patient Reported Outcome Measure scored using a visual analog scale from 0 to 100, with a score of 100 being the best function and least amount of symptoms
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Timepoint [6]
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3-months
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Primary outcome [7]
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International Hip Outcome Tool (iHOT-12)
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Assessment method [7]
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Patient Reported Outcome Measure scored using a visual analog scale from 0 to 100, with a score of 100 being the best function and least amount of symptoms
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Timepoint [7]
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6-months
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Primary outcome [8]
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International Hip Outcome Tool (iHOT-12)
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Assessment method [8]
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Patient Reported Outcome Measure scored using a visual analog scale from 0 to 100, with a score of 100 being the best function and least amount of symptoms
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Timepoint [8]
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9-months
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Primary outcome [9]
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European Quality of life questionnaire (EQ-5D-5L)
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Assessment method [9]
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Patient Reported Outcome Measure
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Timepoint [9]
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Baseline
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Primary outcome [10]
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European Quality of life questionnaire (EQ-5D-5L)
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Assessment method [10]
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Patient Reported Outcome Measure
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Timepoint [10]
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3-months
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Primary outcome [11]
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0
European Quality of life questionnaire (EQ-5D-5L)
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Assessment method [11]
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0
Patient Reported Outcome Measure
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Timepoint [11]
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6-months
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Primary outcome [12]
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0
European Quality of life questionnaire (EQ-5D-5L)
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Assessment method [12]
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0
Patient Reported Outcome Measure
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Timepoint [12]
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9-months
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Primary outcome [13]
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Tampa Scale of Kinesiophobia (TSK)
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Assessment method [13]
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Patient Reported Outcome Measure
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Timepoint [13]
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Baseline
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Primary outcome [14]
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Tampa Scale of Kinesiophobia (TSK)
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Assessment method [14]
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Patient Reported Outcome Measure
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Timepoint [14]
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3-months
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Primary outcome [15]
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Tampa Scale of Kinesiophobia (TSK)
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Assessment method [15]
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Patient Reported Outcome Measure
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Timepoint [15]
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6-months
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Primary outcome [16]
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Tampa Scale of Kinesiophobia (TSK)
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Assessment method [16]
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Patient Reported Outcome Measure
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Timepoint [16]
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9-months
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Primary outcome [17]
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Hip Strength assessment
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Assessment method [17]
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Strength of hip abduction, adduction, sitting hip flexion at 90deg, prone extension with knee extended, prone external and internal rotation will be measured using a hand-held dynamometer.
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Timepoint [17]
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Baseline
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Primary outcome [18]
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Hip Strength assessment
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Assessment method [18]
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Strength of hip abduction, adduction, sitting hip flexion at 90deg, prone extension with knee extended, prone external and internal rotation will be measured using a hand-held dynamometer.
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Timepoint [18]
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9-months
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Primary outcome [19]
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Hip Range of Motion
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Assessment method [19]
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Hip flexion, Hip internal rotation and external rotation will be measured using an inclinometer
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Timepoint [19]
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Baseline
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Primary outcome [20]
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Hip Range of Motion
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Assessment method [20]
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Hip flexion, Hip internal rotation and external rotation will be measured using an inclinometer
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Timepoint [20]
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9-months
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Secondary outcome [1]
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Functional movement screen Y-balance test
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Assessment method [1]
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This will measure a circus performers capacity to stand on one leg and reach their opposite leg as far as possible forwards, backwards and sideways. This provides a measure of both strength and flexibility, has been used in prior hip research, and shown to have excellent intra and inter-rater reliability.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Functional movement screen Y-balance test
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Assessment method [2]
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This will measure a circus performers capacity to stand on one leg and reach their opposite leg as far as possible forwards, backwards and sideways. This provides a measure of both strength and flexibility, has been used in prior hip research, and shown to have excellent intra and inter-rater reliability.
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Timepoint [2]
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9-months
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Secondary outcome [3]
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Single leg Hop for distance
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Assessment method [3]
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The distance of a participant hop will be measured, taking off and landing on the same foot, maintaining their balance for about 2-3 seconds on landing. The best of three hops will be recorded.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Single leg Hop for distance
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Assessment method [4]
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The distance of a participant hop will be measured, taking off and landing on the same foot, maintaining their balance for about 2-3 seconds on landing. The best of three hops will be recorded.
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Timepoint [4]
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9-months
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Secondary outcome [5]
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Trunk Muscle Endurance Test
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Assessment method [5]
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The duration of a side-plank will be recorded in seconds/minutes. The test will be ceased after 3 minutes.
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Trunk Muscle Endurance Test
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Assessment method [6]
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The duration of a side-plank will be recorded in seconds/minutes. The test will be ceased after 3 minutes.
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Timepoint [6]
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9-months
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Secondary outcome [7]
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One leg rise test
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Assessment method [7]
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The number of sit to stand movements on a single leg performed from a starting position where the knee is at 90deg will be recorded. The test will be ceased if the participant reaches 50 one leg rises.
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Timepoint [7]
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Baseline
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Secondary outcome [8]
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One leg rise test
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Assessment method [8]
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The number of sit to stand movements on a single leg performed from a starting position where the knee is at 90deg will be recorded. The test will be ceased if the participant reaches 50 one leg rises.
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Timepoint [8]
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9-months
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Eligibility
Key inclusion criteria
* 3-month history hip/groin pain +/- symptoms including clicking, giving way, locking, or catching, one or more of a positive
* positive FADIR pain provocation test
* positive HEER test (hip extension and external rotation)
* positive prone instability test
* imaging to support a pathological hip (e.g., CAM morphology, hip dysplasia)
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* OA degree >1 on classification of Tönnis
* Centre Edge-angle <10 degrees
* Legg-Calvé-Perthes or epiphysiolysis
* history of hip joint surgery or significant hip trauma (fracture +/- dislocation)
* neurologic motor deficit (lower limb power, strength or reflex deficit)
* hip pain from a lumbar origin (positive passive straight leg raise, combined lumbar extension and rotation)
* connective tissue disorder (e.g., Ehlers-danlos or Marfan syndrome)
* pregnancy or breastfeeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/03/2024
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Swinburne University of Technology - Hawthorn
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Recruitment postcode(s) [1]
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3122 - Hawthorn
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Funding & Sponsors
Primary sponsor type
Other
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Name
Swinburne University of Technology
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Institute of Circus Arts
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Hip injuries are reported to account for 71% and 29% of all injuries reported in female and male performers, respectively, at the National Institute of Circus Arts. There are no reports on hip pathology in circus performers, nor are there any reported exercise interventions for hip pain in circus performers. This study aims to: To assess the effect of an exercise rehabilitation program on patient-reported outcome measures, hip strength and range of movement, and functional assessments in circus arts students with clinically and radiologically diagnosed hip pain-related disorders. Participants will undertake a 12-week strength exercise protocol that has been specifically designed to focus on hip rehabilitation appropriate for circus performance. Expected outcome: Improvements in patient reported outcome measure (PROM) scores and an increase in function, strength and hip range of movement in people with hip pain
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Trial website
https://clinicaltrials.gov/study/NCT05687955
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
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
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05687955