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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05138380
Registration number
NCT05138380
Ethics application status
Date submitted
2/11/2021
Date registered
1/12/2021
Date last updated
11/10/2023
Titles & IDs
Public title
Hip Osteoarthritis and Foot Orthoses Trial (HOOT)
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Scientific title
Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial
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Secondary ID [1]
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HOOT
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Universal Trial Number (UTN)
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Trial acronym
HOOT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Foot orthoses
Treatment: Devices - Flat shoe insert
Experimental: Foot orthoses -
Sham comparator: Flat shoe insert -
Treatment: Devices: Foot orthoses
Manufacturer: Foot Science International.
Material: High grade thermoformable closed-cell polyolefin foam (medium density)
Arch support: inbuilt.
Covering: fabric
Provided by: Study Practitioner: Registered physiotherapist \> 2 years musculoskeletal experience will be trained to prescribe the insert according to the prescription algorithm.
Where: Administered via telehealth
When and how much: Week 0 to 1: one telehealth session with study practitioner to fit one pair of pre-fabricated orthoses Week 1 to 2: Follow-up session for questions if required
Tailoring: Orthoses are fit to comfort. Lengths (S, S, M, L, XL, XXL) (dependent on participant's shoe size). Hardness = Medium density. Modifications: can be cut to size to assist in fit using the shoes original sock liner as a guide, by participants using standard scissors. Heat molding: optional.
Adherence: Adherence recorded with diary/ log book (insert wear time)
Treatment: Devices: Flat shoe insert
Manufacturer: Foot Science International.
Material: High grade thermoformable closed-cell polyolefin foam (medium density)
Arch support: no.
Covering: fabric
Provided by: Study Practitioner: Registered physiotherapist \> 2 years musculoskeletal experience will be trained to prescribe the insert according to the prescription algorithm.
Where: Administered via telehealth
When and how much: Week 0 to 1: one telehealth session with study practitioner to fit one pair of pre-fabricated orthoses Week 1 to 2: Follow-up session for questions if required
Tailoring: Fit to comfort. Lengths (S, S, M, L, XL, XXL) (dependent on participant's shoe size). Hardness = Medium density. Modifications: can be cut to size to assist in fit using the shoes original sock liner as a guide, by participants using standard scissors. Heat molding: optional.
Adherence: Adherence recorded with diary/ log book (insert wear time)
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Intervention code [1]
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Treatment: Devices
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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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Feasibility: adherence
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Assessment method [1]
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Recruitment rate (average 1 participant per week); 50% log-book completion rate (daily); drop-out \<20%; 35 hours per week adherence to intervention (log book)
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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Hip-related pain
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Assessment method [1]
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Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes)
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Timepoint [1]
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Baseline and 6 weeks
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Secondary outcome [2]
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Hip-related physical function
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Assessment method [2]
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Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes)
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Timepoint [2]
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Baseline and 6 weeks
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Secondary outcome [3]
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Hip-related quality of life
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Assessment method [3]
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hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes)
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Timepoint [3]
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Baseline and 6 weeks
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Secondary outcome [4]
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Fear of movement
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Assessment method [4]
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Brief Fear of Movement Scale for osteoarthritis (BFOM); 0 to 24, with a higher score indicating lower fear of movement (better score)
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Timepoint [4]
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Baseline and 6 weeks
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Secondary outcome [5]
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Depressive symptoms
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Assessment method [5]
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Patient Health Questionnaire -9: Scored from 0 to 27, participants can be classified as having mild (= 5), moderate (= 10), moderately severe (= 15) and severe (= 20) depressive symptoms.
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Timepoint [5]
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Baseline and 6 weeks
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Secondary outcome [6]
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Physical activity- Self-reported
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Assessment method [6]
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The International Physical Activity Questionnaire: Participants will be asked to recall their physical activity over the last 7 days with regard to vigorous physical activity, moderate physical activity, walking and sitting.
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Timepoint [6]
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Baseline and 6 weeks
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Secondary outcome [7]
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Physical activity- Walking based physical activity
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Assessment method [7]
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Will be measured with a tri-axial accelerometer-based activity monitor that is attached on the thigh (activPAL model 4 micro; PAL Technologies Ltd, Glasgow, UK) and will be expressed as a) daily minutes of moderate and vigorous physical activity using the established 100 steps/minute threshold and b) total daily steps (which captures both inside and outside the home walking activity).
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Timepoint [7]
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Baseline and 6 weeks
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Secondary outcome [8]
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Global rating of change- Physical activity
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Assessment method [8]
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Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse
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Timepoint [8]
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Week 6
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Secondary outcome [9]
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Global rating of change- Symptoms
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Assessment method [9]
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Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse
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Timepoint [9]
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Week 6
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Eligibility
Key inclusion criteria
Primary symptomatic and radiographic hip OA, in accordance with the American College of Rheumatology
(i) aged > 45 years;
(ii) pain in the hip or groin for more than 3 months;
(iii) average pain intensity over the past week of > 3 out of 10 (Numerical Rating Scale) during functional tasks like walking, climbing stairs or climbing in/out of a car;
(iv) radiographic confirmation of hip osteoarthritis with a Kellgren-Lawrence score = 2 within the last 12 months;
(v) mild to moderate disability indicated by;
1. able to reciprocally ascend and descend 10 stairs unaided,
2. able to safely walk one city block, and
3. able to jog five meters if required
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Minimum age
45
Years
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Maximum age
No limit
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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
(i) other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (Doctor, Physiotherapist, Podiatrist etc) in the last 6 months;
(ii) have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months;
(iii) history of hip trauma or surgery on the affected side;
(iv) corticosteroid use (oral or intra-articular injection) in the past 3 months
(v) neurological impairment or condition affecting lower limb function
(vi) conditions or factors affecting ability to take part in the intervention, e.g., unavailable for a 6 week intervention period, routine use of gait aids, uncontrolled hypertension, or morbid obesity (body mass index > 40);
(vii) Use of foot orthoses in the previous 12 months
(viii) systemic inflammatory disease (e.g. rheumatoid arthritis);
(ix) unable to write, read or comprehend English.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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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
1/02/2022
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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
26/10/2025
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Actual
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Sample size
Target
28
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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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La Trobe University - Bundoora
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Recruitment postcode(s) [1]
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3086 - Bundoora
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Funding & Sponsors
Primary sponsor type
Other
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Name
La Trobe University
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This trial is a randomized feasibility trial to determine the feasibility of comparing two different shoe inserts and on pain, quality of life and physical activity associated with hip osteoarthritis.
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Trial website
https://clinicaltrials.gov/study/NCT05138380
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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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Adam Semciw, PhD
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Address
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La Trobe University
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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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Adam Semciw, PhD
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Address
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Country
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Phone
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+61394796452
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT05138380
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