Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

NCT05138380 | Unknown

• 1 other identifier: HOOT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (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)

  6 weeks

Secondary Outcomes (9)

• Hip-related pain

  Baseline and 6 weeks

• Hip-related physical function

  Baseline and 6 weeks

• Hip-related quality of life

  Baseline and 6 weeks

• Fear of movement

  Baseline and 6 weeks

• Depressive symptoms

  Baseline and 6 weeks

Study Arms (2)

Foot orthoses

EXPERIMENTAL

Device: Foot orthoses

Flat shoe insert

SHAM COMPARATOR

Device: Flat shoe insert

Interventions

Foot orthoses DEVICE

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)

Also known as: Foot Science International Ltd; Formthotic

Foot orthoses

Flat shoe insert DEVICE

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)

Flat shoe insert

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• able to reciprocally ascend and descend 10 stairs unaided,
• able to safely walk one city block, and
• able to jog five meters if required

You may not qualify if:

• (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.

Sponsors & Collaborators

• La Trobe University: lead

Study Sites (1)

La Trobe University

Bundoora, Victoria, 3086, Australia

RECRUITING

Related Publications (2)

• 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.

  PMID: 39132922 DERIVED

• 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.

  PMID: 36691129 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Adam Semciw, PhD

  La Trobe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Semciw, PhD

CONTACT

+61394796452; a.semciw@latrobe.edu.au

Matthew King, PhD

CONTACT

+61394793531; m.king@latrobe.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessor blinding: Participants complete their own outcome measures (questionnaires) online and are thus not blind. Accelerometry data will be assessor blinded. All outcome measures will be analysed by an investigator blind to participant group allocation. Participants will be instructed not to divulge any aspect of their intervention to the research assistant conducting follow-up assessments. Participant blinding: Participants will be advised that they have an equal chance of being allocated to the either shoe insert, and thus are blind to allocation. Participants will also be blind to the study hypothesis, so they are unaware which of the interventions is 'active'. Physiotherapist blinding: It is not possible to blind the trial physiotherapist to group allocation. Trial Physiotherapists will however not be involved in assessment of outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, participant blinded, parallel group feasibility RCT

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 1, 2021
• Study Start: February 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: October 26, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-03

Locations

AU (1)