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Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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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Eligibility

Age eligible for study : 45 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-02-01

Primary completion: 2024-08-01

Study completion finish: 2025-10-26

Study type

TREATMENT

Phase

Trial ID

NCT05138380

Intervention or treatment

DEVICE: Foot orthoses

DEVICE: Flat shoe insert

Conditions

• Hip Osteoarthritis

Condition: Hip Osteoarthritis
DEVICE: Foot orthoses and other drugs
Bundoora, Victoria, Australia
Sponsor: La Trobe University

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Find a site

Closest Location:

La Trobe University

Research sites nearby

Select from list below to view details:

La Trobe University
Bundoora, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Foot orthoses Not Specified	DEVICE: 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)
SHAM_COMPARATOR: Flat shoe insert Not Specified	DEVICE: 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)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Foot orthoses

Not Specified

DEVICE: 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)

SHAM_COMPARATOR: Flat shoe insert

Not Specified

DEVICE: 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)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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)	6 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Hip-related pain	Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes)	Baseline and 6 weeks
Hip-related physical function	Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes)	Baseline and 6 weeks
Hip-related quality of life	hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes)	Baseline and 6 weeks
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)	Baseline and 6 weeks
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.	Baseline and 6 weeks
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.	Baseline and 6 weeks
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).	Baseline and 6 weeks
Global rating of change- Physical activity	Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse	Week 6
Global rating of change- Symptoms	Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse	Week 6

Frequently Asked Questions

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References

Clinical Trials Gov: Hip Osteoarthritis and Foot Orthoses Trial (HOOT)