Osteoarthritis, KneeSENSMODNCT04323969
Gait Modification for Knee Osteoarthritis
A study testing Specific Modification Target and Self-directed Modification in people with Osteoarthritis, Knee, run by University of British Columbia at 1 site in Canada.
Trial summary
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Specific Modification Target and Self-directed Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2020to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 50 years of age or greater
- Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
- Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
- Are comfortable walking intermittently for 30 minutes
- Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
- Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.
Who cannot join
- Any knee surgery or intraarticular injections within the past 6 months
- A history of joint replacement surgery or high tibial osteotomy
- Current or recent (within 6 weeks) corticosteroid injections
- Use of a gait aid
- Currently on a wait list for joint replacement surgery or high tibial osteotomy
- Any inflammatory arthritic condition
- Any other conditions that may affect normal gait or participation in an aerobic exercise program
- Cannot attend all required appointments.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Motion Analysis and Biofeedback Laboratory
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.
Read the detailed description
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Specific Modification Target, Self-directed Modification
- Keywords
- Gait Modification, Wearable Sensors
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Modification TargetBehavioural
Participants will be instructed to increase their baseline foot progression angle by 15 degrees. Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror). Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.
Self-directed ModificationBehavioural
Participants will be instructed to modify their foot progression angle as much as is comfortable. A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Specific Modification Target | Experimental | A 15 degree relative increase to foot progression angle Receives: Behavioral: Specific Modification Target |
| Self-directed Modification | Experimental | A self-directed increase to foot progression angle that is "as much as is comfortable". Receives: Behavioral: Self-directed Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline to week 7 foot rotation angle error during stance - in lab walking
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
Measured: Baseline, Week 7
Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.
Measured: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
Secondary outcomes (4)
Change in baseline to week 7 knee joint moment impulse
Knee flexion and adduction moment impulses will be calculated. Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks. Moments will be calculated using an inverse dynamics approach.
Measured: Baseline, Week 7
Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline, Week 7
Change in baseline to week 7 knee pain on a numerical rating scale
Knee pain rated on a 0 to 10 scale. 0 = "no pain at all" and 10 = "worst pain imaginable".
Measured: Baseline, Week 7
Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".
Measured: Week 1, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start20 Feb 2020
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: COVID-related laboratory shutdown.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hunt, University of British Columbia
- Investigators
- Michael Hunt, PT, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323969
- Sponsor's protocol ID
- H19-02621
- Acronym
- SENSMOD
- Status last verified
- Oct 2020
- First submitted
- 3 Feb 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04323969
- Acronym / sponsor ID
- SENSMOD / H19-02621
- Conditions
- Osteoarthritis, Knee
- Keywords
- Gait Modification, Wearable Sensors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-related laboratory shutdown.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.
Detailed description
Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Modification Target | Experimental | Behavioral: Specific Modification TargetA 15 degree relative increase to foot progression angle |
| Self-directed Modification | Experimental | Behavioral: Self-directed ModificationA self-directed increase to foot progression angle that is "as much as is comfortable". |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 50 years of age or greater
- Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
- Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
- Are comfortable walking intermittently for 30 minutes
- Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
Key exclusion criteria (8 listed)
- Any knee surgery or intraarticular injections within the past 6 months
- A history of joint replacement surgery or high tibial osteotomy
- Current or recent (within 6 weeks) corticosteroid injections
- Use of a gait aid
- Currently on a wait list for joint replacement surgery or high tibial osteotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Modification TargetParticipants will be instructed to increase their baseline foot progression angle by 15 degrees. Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror). Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible. | Behavioural | Specific Modification Target |
| Self-directed ModificationParticipants will be instructed to modify their foot progression angle as much as is comfortable. A mirror will be used during practice for visual feedback, but no specific target or guide will be provided. | Behavioural | Self-directed Modification |
Primary outcome
Change in baseline to week 7 foot rotation angle error during stance - in lab walking
Time frame: Baseline, Week 7
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.
4 secondary outcomes
Change in baseline to week 7 knee joint moment impulse
Time frame: Baseline, Week 7
Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, Week 7
Change in baseline to week 7 knee pain on a numerical rating scale
Time frame: Baseline, Week 7
Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
Time frame: Week 1, 7
Results and safety
The study was stopped early (reason given: COVID-related laboratory shutdown.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hunt, PT, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Modification Target and Self-directed Modification in people with Osteoarthritis, Knee, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-related laboratory shutdown.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline to week 7 foot rotation angle error during stance - in lab walking (time frame: Baseline, Week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.