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CompletedNCT02019108Updated Jul 5, 2019Results posted

Gait Modification Treatment for Knee Osteoarthritis

An interventional study of Progressive walking program with toe-out gait modification and Progressive walking program in Knee Osteoarthritis, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian adults. Excessive and unbalanced loads passing through the knee joint have been implicated in the progression of OA. Typical conservative treatment of OA has focused on increasing daily activity, without consideration for the underlying joint loading. This study aims to compare a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during walking - a measure shown to reduce joint loading and OA disease progression - while increasing walking time/distance, with a standard walking program that aims to increase walking time/distance. It is predicted that the walking program focusing on increasing toe-out will provide greater reductions in self-reported knee pain and a greater reduction in unfavorable knee joint loading.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • osteoarthritis
  • knee
  • walking
  • toeout
  • gait modification
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 79 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged 50 years and older
  • radiographically confirmed medial compartment tibia-femoral knee osteoarthritis
  • available for weekly training sessions in the Vancouver British Columbia Canada region
  • able to safely perform treadmill walking under therapist supervision

Exclusion criteria

Exclusion Criteria:

  • articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
  • inflammatory arthritic condition
  • history of knee replacement or arthroscopic knee surgery
  • recent use of corticosteroids (oral or via injection)
  • inability to ambulate without a gait aid
  • non-English speaking
  • planning to commence a new treatment approach within the next 4 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    Gait Modification Group

    Participants will complete 4 months of a home-based progressive walking program with toe-out gait modification aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with a study therapist and will be instructed to perform a toe-out gait, with the aid of a mirror during walking. Focus will also be on increasing the time and distance of walking. These goals will be emphasized for the home-based portion of the intervention as well.

    Other: Progressive walking program with toe-out gait modification

  • Active comparator
    Walking Only Group

    Participants will complete 4 months of a home-based progressive walking program aimed at improving physical activity level. This group will perform continuous treadmill walking during regular sessions with the study therapist with focus on increasing the time and distance of walking. This goal will be emphasized for the home-based portion of the intervention as well.

    Other: Progressive walking program

Interventions

  • OtherProgressive walking program with toe-out gait modification

    Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group.

  • OtherProgressive walking program

    At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity.

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale

    Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline.

    Time frame: Weeks 0, 17, 21

  2. Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.

    Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome.

    Time frame: Weeks 0, 17, 21

  3. Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment

    Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

    Time frame: Weeks 0, 17, 21

  4. Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment

    Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

    Time frame: Weeks 0, 17, 21

  5. Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse

    Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

    Time frame: Weeks 0, 17, 21

  6. Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)

    FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out.

    Time frame: Weeks 0, 17, 21

Secondary outcomes

  1. Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.

    Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome.

    Time frame: Weeks 0, 17, 21

  2. Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.

    Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded.

    Time frame: Weeks 0, 17, 21

  3. Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment

    Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

    Time frame: Weeks 0, 17, 21

07

Results

Posted Jul 5, 2019

Participant flow

Participant flow — Overall Study
MilestoneGait Modification GroupWalking Only Group
Started4039
Baseline (week 0)4039
Follow-up (week 17)3836
Retention (week 21)3532
Completed3532
Not completed57
Withdrew: Lost to follow-up57

Outcome measures

PrimaryChange From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale

Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · units on a scale
Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale
units on a scaleGait Modification GroupWalking Only Group
Change from Baseline to Week 17-2.1 (-2.7 to -1.5)-1.8 (-2.4 to -1.2)
Change from Baseline to Week 21-2.2 (-2.8 to -1.7)-1.5 (-2.1 to -0.9)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.495 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.3 · 95% CI -1.1 to 0.5Controlling for baseline values.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.079 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.8 · 95% CI -1.6 to 0.1Controlling for baseline values.
PrimaryChange From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.

Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · units on a scale
Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.
units on a scaleGait Modification GroupWalking Only Group
Change from Baseline to Week 17-2.7 (-3.6 to -1.7)-1.5 (-2.5 to -0.5)
Change from Baseline to Week 21-2.5 (-3.5 to -1.6)-1.5 (-2.5 to -0.5)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.117 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -1.1 · 95% CI -2.6 to 0.3Controlling for baseline values.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.133 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -1.1 · 95% CI -2.5 to 0.3Controlling for baseline values.
PrimaryChange From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment

Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · %Body Weight*Height
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment
%Body Weight*HeightGait Modification GroupWalking Only Group
Change from Baseline to Week 17-0.01 (-0.13 to 0.11)0.13 (0.00 to 0.26)
Change from Baseline to Week 21-0.06 (-0.20 to 0.08)0.11 (-0.04 to 0.26)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.125 (a priori threshold for statistical significance \<0.05) · Median difference (final values): -0.14 · 95% CI -0.31 to 0.04Controlling for baseline values and walking speed.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.103 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.17 · 95% CI -0.37 to 0.03Controlling for baseline values and walking speed.
PrimaryChange From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment

Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · %Body Weight*Height
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment
%Body Weight*HeightGait Modification GroupWalking Only Group
Change from Baseline to Week 17-0.24 (-0.33 to -0.15)0.02 (-0.08 to 0.11)
Change from Baseline to Week 21-0.19 (-0.33 to -0.04)0.01 (-0.14 to 0.16)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = <0.001 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.26 · 95% CI -0.39 to -0.12Controlling for baseline values and walking speed.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.056 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.20 · 95% CI -0.40 to 0.01Controlling for baseline values and walking speed.
PrimaryChange From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse

Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · %Body Weight*Height*seconds
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse
%Body Weight*Height*secondsGait Modification GroupWalking Only Group
Change from Baseline to Week 17-0.04 (-0.08 to -0.01)0.01 (-0.02 to 0.05)
Change from Baseline to Week 21-0.06 (-0.10 to -0.02)0.00 (-0.04 to 0.05)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.031 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.06 · 95% CI -0.11 to -0.01Controlling for baseline values and walking speed.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.058 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.06 · 95% CI -0.12 to 0.00Controlling for baseline values and walking speed.
PrimaryChange From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)

FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · degrees
Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)
degreesGait Modification GroupWalking Only Group
Change from Baseline to Week 17-8.87 (-10.36 to -7.39)0.17 (-1.41 to 1.74)
Change from Baseline to Week 21-6.96 (-8.35 to -5.58)-0.18 (-1.66 to 1.29)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = <0.001 (a priori threshold for statistical significance \<0.05.) · Mean difference (final values): -9.04 · 95% CI -11.22 to -6.86Controlling for baseline values and walking speed.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = <0.001 (a priori threshold for statistical significance \<0.05.) · Mean difference (final values): -6.78 · 95% CI -8.82 to -4.75Controlling for baseline values and walking speed.
SecondaryChange From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.

Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · units on a scale
Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.
units on a scaleGait Modification GroupWalking Only Group
Change from Baseline to Week 17-11.4 (-14.6 to -8.3)-7.7 (-10.9 to -4.5)
Change from Baseline to Week 21-9.4 (-12.4 to -6.3)-6.6 (-9.8 to -3.4)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.111 (a priori threshold for statistical significance \<0.05.) · Mean difference (final values): -3.7 · 95% CI -8.3 to 0.9Controlling for baseline values.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.232 (a priori threshold for statistical significance \<0.05.) · Mean difference (final values): -2.7 · 95% CI -7.3 to 1.8Controlling for baseline values.
SecondaryChange From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.

Participants were instructed to ascend 12 stairs "as quickly as possible", and the fastest time from two attempts was recorded.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · seconds
Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.
secondsGait Modification GroupWalking Only Group
Change from Baseline to Week 17-0.16 (-0.55 to 0.24)-0.37 (-0.78 to 0.05)
Change from Baseline to Week 21-0.44 (-0.89 to 0.01)-0.33 (-0.80 to 0.14)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.462 (a priori threshold for significance \<0.05.) · Mean difference (final values): 0.21 · 95% CI -0.36 to 0.78Controlling for baseline values.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.737 (a priori threshold for statistical significance \<0.05.) · Mean difference (final values): -0.11 · 95% CI -0.76 to 0.54Controlling for baseline values.
SecondaryChange From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment

Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 "acceptable" (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed.

Time frame:
Weeks 0, 17, 21
Reported as:
Least squares mean · %Body Weight*Height
Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment
%Body Weight*HeightGait Modification GroupWalking Only Group
Change from Baseline to Week 170.06 (-0.26 to 0.38)0.09 (-0.24 to 0.43)
Change from Baseline to Week 210.31 (-0.01 to 0.62)0.28 (-0.06 to 0.61)
Statistical analysis
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.876 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): -0.03 · 95% CI -0.50 to 0.43Controlling for baseline values and walking speed.
  • Gait Modification Group vs Walking Only Group · ANCOVA · p = 0.897 (a priori threshold for statistical significance \<0.05) · Mean difference (final values): 0.03 · 95% CI -0.43 to 0.49Controlling for baseline values and walking speed.

Adverse events

Collected over Adverse event data were collected during weeks 1 - 16 by diary entry and at each visit (Weeks 1, 2, 4, 6, 8, 10, 12 and 15) with the study trainer.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gait Modification Group0/40 (0%)0/40 (0%)8/40 (20%)
Walking Only Group0/39 (0%)0/39 (0%)4/39 (10.3%)
Most frequent other events
Most frequent other events
EventGait Modification GroupWalking Only Group
Hip PainMusculoskeletal and connective tissue disorders5/402/39
Foot PainMusculoskeletal and connective tissue disorders0/401/39
Lower Back PainMusculoskeletal and connective tissue disorders1/401/39
Big Toe PainMusculoskeletal and connective tissue disorders1/400/39
Posterior Thigh PainMusculoskeletal and connective tissue disorders1/400/39

Baseline characteristics

Age, Continuous
Age, Continuous(years)Gait Modification GroupWalking Only GroupTotal
Mean64.6 ± 7.665.4 ± 9.665.0 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Gait Modification GroupWalking Only GroupTotal
Female272855
Male131124
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Gait Modification GroupWalking Only GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Gait Modification GroupWalking Only GroupTotal
Canada403979
Body Mass Index
Body Mass Index(kg/m^2)Gait Modification GroupWalking Only GroupTotal
Mean27.3 ± 3.527.4 ± 3.527.4 ± 3.5
Radiographic Severity
Radiographic Severity(Participants)Gait Modification GroupWalking Only GroupTotal
Mild (KL2)191837
Moderate (KL3)171431
Severe (KL4)4711
08

Study locations

1 site
  • Motion Analysis and Biofeedback Laboratory, The University of British Columbia
    Vancouver, British Columbia V6T 1Z3, Canada
09

References and documents

Publications

  • Hunt MA, Charlton JM, Krowchuk NM, Tse CTF, Hatfield GL. Clinical and biomechanical changes following a 4-month toe-out gait modification program for people with medial knee osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2018 Jul;26(7):903-911. doi: 10.1016/j.joca.2018.04.010. Epub 2018 Apr 27. PubMed 29709498 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 25, 2013

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02019108
Lead sponsor
University of British Columbia
Collaborators
University of Melbourne, Arthritis Research Centre of Canada
Responsible party
Michael Hunt (Associate Professor, University of British Columbia) — Principal investigator
First posted
Dec 24, 2013
Start date
May 2014
Primary completion
Oct 2017
Completion
Oct 2017
Results posted
Jul 5, 2019
Last update
Jul 5, 2019

Study contacts

Michael A Hunt, PT, PhD
principal investigator · The University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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