NCT05138380

Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: La Trobe University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2022-02-01
• Primary completion: 2024-08-01
• Completion: 2025-10-26
• First posted: 2021-12-01
• Last updated: 2023-10-11

Locations

1 site across 1 country: Australia