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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05687955
Other study ID # SwinburneUT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date March 30, 2024

Study information

Verified date May 2023
Source Swinburne University of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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) 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.

Study Design


Intervention

Other:
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.

Locations

Country Name City State
Australia Swinburne University of Technology Hawthorn Victoria

Sponsors (2)

Lead Sponsor Collaborator
Swinburne University of Technology National Institute of Circus Arts

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Copenhagen Hip and Groin Outcome Score (HAGOS) 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. Baseline
Primary The Copenhagen Hip and Groin Outcome Score (HAGOS) 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. 3-months
Primary The Copenhagen Hip and Groin Outcome Score (HAGOS) 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. 6-months
Primary The Copenhagen Hip and Groin Outcome Score (HAGOS) 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. 9-months
Primary International Hip Outcome Tool (iHOT-12) 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 Baseline
Primary International Hip Outcome Tool (iHOT-12) 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 3-months
Primary International Hip Outcome Tool (iHOT-12) 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 6-months
Primary International Hip Outcome Tool (iHOT-12) 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 9-months
Primary European Quality of life questionnaire (EQ-5D-5L) Patient Reported Outcome Measure Baseline
Primary European Quality of life questionnaire (EQ-5D-5L) Patient Reported Outcome Measure 3-months
Primary European Quality of life questionnaire (EQ-5D-5L) Patient Reported Outcome Measure 6-months
Primary European Quality of life questionnaire (EQ-5D-5L) Patient Reported Outcome Measure 9-months
Primary Tampa Scale of Kinesiophobia (TSK) Patient Reported Outcome Measure Baseline
Primary Tampa Scale of Kinesiophobia (TSK) Patient Reported Outcome Measure 3-months
Primary Tampa Scale of Kinesiophobia (TSK) Patient Reported Outcome Measure 6-months
Primary Tampa Scale of Kinesiophobia (TSK) Patient Reported Outcome Measure 9-months
Primary Hip Strength assessment 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. Baseline
Primary Hip Strength assessment 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. 9-months
Primary Hip Range of Motion Hip flexion, Hip internal rotation and external rotation will be measured using an inclinometer Baseline
Primary Hip Range of Motion Hip flexion, Hip internal rotation and external rotation will be measured using an inclinometer 9-months
Secondary Functional movement screen Y-balance test 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. Baseline
Secondary Functional movement screen Y-balance test 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. 9-months
Secondary Single leg Hop for distance 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. Baseline
Secondary Single leg Hop for distance 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. 9-months
Secondary Trunk Muscle Endurance Test The duration of a side-plank will be recorded in seconds/minutes. The test will be ceased after 3 minutes. Baseline
Secondary Trunk Muscle Endurance Test The duration of a side-plank will be recorded in seconds/minutes. The test will be ceased after 3 minutes. 9-months
Secondary One leg rise test 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. Baseline
Secondary One leg rise test 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. 9-months
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