Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
Scientific title
Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial
Secondary ID [1] 0 0
HOOT
Universal Trial Number (UTN)
Trial acronym
HOOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility: adherence
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Hip-related pain
Timepoint [1] 0 0
Baseline and 6 weeks
Secondary outcome [2] 0 0
Hip-related physical function
Timepoint [2] 0 0
Baseline and 6 weeks
Secondary outcome [3] 0 0
Hip-related quality of life
Timepoint [3] 0 0
Baseline and 6 weeks
Secondary outcome [4] 0 0
Fear of movement
Timepoint [4] 0 0
Baseline and 6 weeks
Secondary outcome [5] 0 0
Depressive symptoms
Timepoint [5] 0 0
Baseline and 6 weeks
Secondary outcome [6] 0 0
Physical activity- Self-reported
Timepoint [6] 0 0
Baseline and 6 weeks
Secondary outcome [7] 0 0
Physical activity- Walking based physical activity
Timepoint [7] 0 0
Baseline and 6 weeks
Secondary outcome [8] 0 0
Global rating of change- Physical activity
Timepoint [8] 0 0
Week 6
Secondary outcome [9] 0 0
Global rating of change- Symptoms
Timepoint [9] 0 0
Week 6

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
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/10/2025
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
La Trobe University - Bundoora
Recruitment postcode(s) [1] 0 0
3086 - Bundoora

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05138380
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adam Semciw, PhD
Address 0 0
La Trobe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Adam Semciw, PhD
Address 0 0
Country 0 0
Phone 0 0
+61394796452
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05138380