Osteoarthritis, KneeTELEMODNCT04683913
Telerehabilitation Gait Modification
A study testing Foot rotation modification and Waiting Period - Delayed Group in people with Osteoarthritis, Knee, run by University of British Columbia at 1 site in Canada.
Trial summary
Excessive knee joint loads during walking can contribute to knee osteoarthritis progression. Changing the rotation of the foot (in-toeing or out-toeing) while walking can lower knee joint loads and improve pain and function. 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?
- Foot rotation modification and Waiting Period - Delayed Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 20 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 50 years of age or older
- Exhibit signs of tibiofemoral osteoarthritis based on a score of ≥2 on the Kellgren and Lawrence 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
- Comfortable walking intermittently for 30 minutes
- Fit into the available sizes of sensor shoes (between US women's 5 to men's 13)
- Exhibits ≥2% reduction in knee adduction moment impulse at 10 degrees of change in toe-in or toe-out during the 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 Telerehabilitation Intervention in People With Knee Osteoarthritis
Excessive knee joint loads during walking can contribute to knee osteoarthritis progression. Changing the rotation of the foot (in-toeing or out-toeing) while walking can lower knee joint loads and improve pain and function. Telerehabilitation (using video or telephone communication to delivery rehabilitation) has shown promise in delivering exercise therapy for knee osteoarthritis, but it is unknown if walking modifications can be delivered using this method. This study consists of a six-week walking modification program in people with knee osteoarthritis. Performance of the modification will be measured using motion capture and wearable sensors during practice and daily life.
Read the detailed description
Loads on the knee joint during walking are related to worsening of knee osteoarthritis. Changing walking motions to lower these knee joint loads is an emerging management strategy for knee osteoarthritis. Multiple studies have targeted a change in the position of the foot relative to the direction of walking (toe-in or toe-out walking) and have shown this walking modification to lower knee joint loads and improve symptoms (e.g. pain) related to knee osteoarthritis within the context of a walking program. Building off the many studies that have found telerehabilitation to be an effective method of providing exercise and pain-coping physical therapy, the investigators will use this method to provide walking modification treatment. Telerehabilitation (using video or teleconferencing to conduct the physical therapy appointment) provides a convenient and cost-effective method to work with patients and coordinate their treatment plan. To monitor progress with learning the walking modification, the investigators will use a custom sensor shoe that the participants will wear during daily walking activities over the six-week intervention. Overall, this study will investigate the feasibility and effectiveness of a walking modification program delivered using video- or teleconference.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Foot rotation modification, Waiting Period - Delayed Group
- Keywords
- Gait Modification, Wearable Sensors, Real-world Monitoring, Telerehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot rotation modificationBehavioural
Also called gait modification
The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable".
Waiting Period - Delayed GroupOther
Also called control
Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention: Telerehabilitation | Experimental | Immediate entry into the gait modification intervention delivered using teleconferencing methods Receives: Behavioral: Foot rotation modification |
| Delayed Intervention: Telerehabilitation | Experimental | Delayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods Receives: Behavioral: Foot rotation modification; Other: Waiting Period - Delayed Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lab-measured Performance of Gait Modification
Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted.
Measured: Baseline, Week 6
Real-world Performance of Gait Modification
Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change.
Measured: Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)
Intervention Adherence
Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).
Measured: Week 6
Compliance With Gait Modification
Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = "no confidence" and 10 = "complete confidence") at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10.
Measured: Week 6
Difficulty in Performing the Modification
Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10.
Measured: Week 6
Satisfaction With the Treatment Program
Satisfaction with the gait modification program on a 7-point Likert scale where -3 = "extremely unsatisfied" and +3 = "extremely satisfied". Scores of +2 or +3 will be considered "satisfied" and acceptable.
Measured: Week 6
Secondary outcomes (3)
Knee-osteoarthritis Related Symptoms
Change in pain (9 items), stiffness (7 items), physical function (17 items), and quality of life (4 items) will be measured by the Knee Injury and Osteoarthritis Outcome Score at baseline, follow up and retention. Each item is rated on a 5 points Likert scale where 0 = "No problems" and 4 = "Extreme Problems". Higher scores indicate better function. The scores are normalized to 0-100%.
Measured: Baseline, Week 6
Knee Joint Moments
Peaks and impulse of the knee adduction moment and knee flexion moment measured via in-laboratory gait analysis (force platforms and marker-based motion capture) at baseline, and follow up.
Measured: Baseline, Week 6
Knee Joint Moment Impulse
Impulse of the knee adduction and flexion moments.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- Two-arm delayed control design
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683913
- Sponsor's protocol ID
- H20-03086
- Acronym
- TELEMOD
- Status last verified
- Oct 2024
- First submitted
- 15 Dec 2020
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Progression Angle Modification: an Exploratory Six-week Telerehabilitation Intervention in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04683913
- Acronym / sponsor ID
- TELEMOD / H20-03086
- Conditions
- Osteoarthritis, Knee
- Keywords
- Gait Modification, Wearable Sensors, Real-world Monitoring, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excessive knee joint loads during walking can contribute to knee osteoarthritis progression. Changing the rotation of the foot (in-toeing or out-toeing) while walking can lower knee joint loads and improve pain and function. Telerehabilitation (using video or telephone communication to delivery rehabilitation) has shown promise in delivering exercise therapy for knee osteoarthritis, but it is unknown if walking modifications can be delivered using this method. This study consists of a six-week walking modification program in people with knee osteoarthritis. Performance of the modification will be measured using motion capture and wearable sensors during practice and daily life.
Detailed description
Loads on the knee joint during walking are related to worsening of knee osteoarthritis. Changing walking motions to lower these knee joint loads is an emerging management strategy for knee osteoarthritis. Multiple studies have targeted a change in the position of the foot relative to the direction of walking (toe-in or toe-out walking) and have shown this walking modification to lower knee joint loads and improve symptoms (e.g. pain) related to knee osteoarthritis within the context of a walking program. Building off the many studies that have found telerehabilitation to be an effective method of providing exercise and pain-coping physical therapy, the investigators will use this method to provide walking modification treatment. Telerehabilitation (using video or teleconferencing to conduct the physical therapy appointment) provides a convenient and cost-effective method to work with patients and coordinate their treatment plan. To monitor progress with learning the walking modification, the investigators will use a custom sensor shoe that the participants will wear during daily walking activities over the six-week intervention. Overall, this study will investigate the feasibility and effectiveness of a walking modification program delivered using video- or teleconference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm delayed control design
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention: Telerehabilitation | Experimental | Behavioral: Foot rotation modificationImmediate entry into the gait modification intervention delivered using teleconferencing methods |
| Delayed Intervention: Telerehabilitation | Experimental | Behavioral: Foot rotation modification, Other: Waiting Period - Delayed GroupDelayed (6 weeks) entry into the gait modification intervention delivered using teleconferencing methods |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 years of age or older
- Exhibit signs of tibiofemoral osteoarthritis based on a score of ≥2 on the Kellgren and Lawrence 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
- Comfortable walking intermittently for 30 minutes
- Fit into the available sizes of sensor shoes (between 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 |
|---|---|---|
| Foot rotation modificationAlso: gait modificationThe instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by "as much as is comfortable". | Behavioural | Delayed Intervention: Telerehabilitation, Immediate Intervention: Telerehabilitation |
| Waiting Period - Delayed GroupAlso: controlParticipants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention. | Other | Delayed Intervention: Telerehabilitation |
Primary outcome
Lab-measured Performance of Gait Modification
Time frame: Baseline, Week 6
Change in foot rotation angle between baseline and week 6 (follow-up) appointments measured using marker-based motion capture. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted.
Real-world Performance of Gait Modification
Time frame: Baseline, Week 1&2, Week 3&4, Week 5&6, Follow up (Week 6/12), Retention (Week 10/16)
Change in absolute median foot rotation from baseline to each real-world walking bout (represented as a single data file on the sensor module), follow-up, and retention measured via the sensor shoe. Foot rotation is defined as the angle between the long axis of the foot and the walking direction. Measures of central tendency and variability will be extracted, in addition to the proportion of steps with a greater than or equal to 7 degree change.
Intervention Adherence
Time frame: Week 6
Adherence will be measured by the ratio of telerehabilitation sessions the participant attends relative to the total sessions (5 total).
Compliance With Gait Modification
Time frame: Week 6
Compliance will be estimated by self-reported confidence in performing the gait modification (where 0 = "no confidence" and 10 = "complete confidence") at follow up. Acceptable confidence ratings by week 6 are greater than or equal to 7/10.
Difficulty in Performing the Modification
Time frame: Week 6
Difficulty of performing the modification at week 6. Difficulty measured on an NRS scale (0 = no difficulty and 10 = most difficulty possible). Acceptable difficulty by week 6 is less than or equal to 4/10.
Satisfaction With the Treatment Program
Time frame: Week 6
Satisfaction with the gait modification program on a 7-point Likert scale where -3 = "extremely unsatisfied" and +3 = "extremely satisfied". Scores of +2 or +3 will be considered "satisfied" and acceptable.
3 secondary outcomes
Knee-osteoarthritis Related Symptoms
Time frame: Baseline, Week 6
Knee Joint Moments
Time frame: Baseline, Week 6
Knee Joint Moment Impulse
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot rotation modification and Waiting Period - Delayed Group 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: finished, as of the sponsor's last update on 4 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lab-measured Performance of Gait Modification (time frame: Baseline, Week 6). The study lists 6 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 4 Dec 2024.