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Hip OsteoarthritisHOOTNCT05138380

Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

A study testing Foot orthoses and Flat shoe insert in people with Hip Osteoarthritis, run by La Trobe University at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Hip Osteoarthritis
What is being tested?
Foot orthoses and Flat shoe insert
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteAustralia
Study dates
1 Feb 2022to 26 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary symptomatic and radiographic hip OA, in accordance with the American College of Rheumatology
  • aged > 45 years;
  • pain in the hip or groin for more than 3 months;
  • 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;
  • radiographic confirmation of hip osteoarthritis with a Kellgren-Lawrence score ≥ 2 within the last 12 months;
  • mild to moderate disability indicated by;
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  • able to reciprocally ascend and descend 10 stairs unaided,
  • able to safely walk one city block, and
  • able to jog five meters if required

Who cannot join

  • other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (Doctor, Physiotherapist, Podiatrist etc) in the last 6 months;
  • have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months;
  • history of hip trauma or surgery on the affected side;
  • corticosteroid use (oral or intra-articular injection) in the past 3 months
  • neurological impairment or condition affecting lower limb function
  • 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);
Show all 9Show fewer
  • Use of foot orthoses in the previous 12 months
  • systemic inflammatory disease (e.g. rheumatoid arthritis);
  • unable to write, read or comprehend English.

Trial locations and contacts

1 site in 1 country.

Adam Semciw, PhD contact

+61394796452

a.semciw@latrobe.edu.au

Matthew King, PhD contact

+61394793531

m.king@latrobe.edu.au

Australia1 site, 1 recruiting

  • La Trobe University

    Bundoora, Victoria, 3086

    Adam I Semciw, PhD

    Recruiting

Other trials in Australia

About this study

Official title: Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial

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.

Read the detailed description

Participants will be randomized to one of two groups - contoured prefabricated foot orthoses or flat shoe inserts (the comparator). Participants will be asked to use the inserts daily for a six week period. Adherence to the intervention will be monitored using a daily diary, as well as adverse events and co-interventions. The primary outcome is feasibility domains (Demand, Implementation, Acceptability, Practicality) with secondary outcomes of change in hip-related pain and quality of life and physical activity levels. The primary time-point will be 6-weeks.

Being tested
Foot orthoses, Flat shoe insert
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foot orthosesDevice

    Also called Foot Science International Ltd; Formthotic

    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)

  • Flat shoe insertDevice

    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)

Study groups in NCT05138380
Study groupRoleWhat they receive
Foot orthosesExperimentalNot described
Receives: Device: Foot orthoses
Flat shoe insertSham comparatorNot described
Receives: Device: Flat shoe insert

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: adherence

    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)

    Measured: 6 weeks

Secondary outcomes (9)

  1. Hip-related pain

    Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes)

    Measured: Baseline and 6 weeks

  2. Hip-related physical function

    Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes)

    Measured: Baseline and 6 weeks

  3. Hip-related quality of life

    hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes)

    Measured: Baseline and 6 weeks

  4. Fear of movement

    Brief Fear of Movement Scale for osteoarthritis (BFOM); 0 to 24, with a higher score indicating lower fear of movement (better score)

    Measured: Baseline and 6 weeks

  5. Depressive symptoms

    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.

    Measured: Baseline and 6 weeks

  6. Physical activity- Self-reported

    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.

    Measured: Baseline and 6 weeks

  7. Physical activity- Walking based physical activity

    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).

    Measured: Baseline and 6 weeks

  8. Global rating of change- Physical activity

    Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse

    Measured: Week 6

  9. Global rating of change- Symptoms

    Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start1 Feb 2022
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion26 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm, participant blinded, parallel group feasibility RCT
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05138380
Sponsor's protocol ID
HOOT
Acronym
HOOT
Status last verified
Mar 2023
First submitted
2 Nov 2021
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • King MG, Hon R, Roughead E, Kemp JL, Pizzari T, Wong J, Menz HB, Taylor NF, Harms A, McClelland JA, Semciw AI. Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: A randomised feasibility trial. Physiother Res Int. 2024 Oct;29(4):e2118. doi: 10.1002/pri.2118.

    PubMed 39132922

  • King MG, Kemp JL, Hon R, Pizzari T, Wong J, Menz H, Taylor NF, Harms A, McClelland JA, Semciw AI. Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: protocol for a randomised feasibility trial. BMJ Open. 2022 Sep 6;12(9):e062954. doi: 10.1136/bmjopen-2022-062954.

    PubMed 36691129

Questions about this trial

What is this clinical trial studying?

A study testing Foot orthoses and Flat shoe insert in people with Hip Osteoarthritis, run by La Trobe University at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adam Semciw, PhD (+61394796452, a.semciw@latrobe.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: adherence (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05138380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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