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Hip Osteoarthritis and Foot Orthoses Trial (HOOT) (HOOT)

Primary Purpose

Hip Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Foot orthoses
Flat shoe insert
Sponsored by
La Trobe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • La Trobe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Foot orthoses

Flat shoe insert

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2021
Last Updated
October 9, 2023
Sponsor
La Trobe University
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1. Study Identification

Unique Protocol Identification Number
NCT05138380
Brief Title
Hip Osteoarthritis and Foot Orthoses Trial (HOOT)
Acronym
HOOT
Official Title
Hip Osteoarthritis and Foot Orthoses Trial (HOOT): A Randomized Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
October 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
La Trobe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm, participant blinded, parallel group feasibility RCT
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foot orthoses
Arm Type
Experimental
Arm Title
Flat shoe insert
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Foot orthoses
Other Intervention Name(s)
Foot Science International Ltd; Formthotic
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Flat shoe insert
Intervention Description
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)
Primary Outcome Measure Information:
Title
Feasibility: adherence
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Hip-related pain
Description
Hip osteoarthritis outcome score: pain sub-scale (HOOS-12). Scores range for 0 (better outcomes) - 100 (worse outcomes)
Time Frame
Baseline and 6 weeks
Title
Hip-related physical function
Description
Hip osteoarthritis outcome score: function and daily living subscale. Scores range for 0 (better outcomes) - 100 (worse outcomes)
Time Frame
Baseline and 6 weeks
Title
Hip-related quality of life
Description
hip osteoarthritis outcome score: quality of life subscale: Scores range for 0 (better outcomes) - 100 (worse outcomes)
Time Frame
Baseline and 6 weeks
Title
Fear of movement
Description
Brief Fear of Movement Scale for osteoarthritis (BFOM); 0 to 24, with a higher score indicating lower fear of movement (better score)
Time Frame
Baseline and 6 weeks
Title
Depressive symptoms
Description
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.
Time Frame
Baseline and 6 weeks
Title
Physical activity- Self-reported
Description
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.
Time Frame
Baseline and 6 weeks
Title
Physical activity- Walking based physical activity
Description
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).
Time Frame
Baseline and 6 weeks
Title
Global rating of change- Physical activity
Description
Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse
Time Frame
Week 6
Title
Global rating of change- Symptoms
Description
Seven point rating scale. Much better, better, a little better, no change, a little worse, worse, much worse
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; able to reciprocally ascend and descend 10 stairs unaided, able to safely walk one city block, and 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Semciw, PhD
Phone
+61394796452
Email
a.semciw@latrobe.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew King, PhD
Phone
+61394793531
Email
m.king@latrobe.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Semciw, PhD
Organizational Affiliation
La Trobe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Trobe University
City
Bundoora
State/Province
Victoria
ZIP/Postal Code
3086
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam I Semciw, PhD

12. IPD Sharing Statement

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Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

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