Osteoarthritis, KneeNCT04148807
Effectiveness of a Walking Intervention on Impact Loading and Pain
A study testing Progressive Walking with Gait Retraining and Progressive Walking Program in people with Osteoarthritis, Knee and Knee Pain Chronic, run by Northeastern University at 1 site in United States.
Trial summary
This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Knee Pain Chronic
- What is being tested?
- Progressive Walking with Gait Retraining and Progressive Walking Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 30 Mar 2023
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a clinical definition of knee OA using NICE guidelines:
- Age ≥ 45
- Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
- History of knee pain for at least 3 months
- Morning stiffness in the morning lasting less than 30 minutes
Who cannot join
- Walk with an assistive device
- Current use of oral opiates or centrally acting pain medications
- History of lower extremity surgery
- Underwent an intra-articular knee joint injection in the past 3 months
- Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
- Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study
- Currently pregnant
- Skin allergies to adhesives
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northeastern University
Boston, Massachusetts, 02115
Joshua Stefanik, MSPT, PhD
About this study
This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.
Read the detailed description
Knee osteoarthritis (OA) is a chronic condition affecting ~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA.
At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold.
Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic
- Being tested
- Progressive Walking with Gait Retraining, Progressive Walking Program
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Walking with Gait RetrainingBehavioural
A progressive walking program with gait retraining will be performed on a treadmill at self-selected comfortable walking speed wearing an inertial measurement unit (IMU) on the medial aspect of the distal tibia. The (vertical) peak positive acceleration (PPA) of the tibia is a measure of tibial shock. Subjects will be provided real-time audio feedback to reduce PPA by 20% of their average peak PPA. During retraining sessions, a faded feedback approach will be used. Feedback will be provided continuously during the first four sessions and will be faded over the last 4 sessions. Walking time will increase over the 8 sessions.
Progressive Walking ProgramBehavioural
A progressive walking program will also be performed on a treadmill where subjects will walk at a self-selected comfortable speed with the same walking times per session as the retraining group without any feedback or retraining cues.
| Study group | Role | What they receive |
|---|---|---|
| Progressive walking program with gait retraining | Experimental | Participant will receive 8 gait-retraining intervention sessions. Receives: Behavioral: Progressive Walking with Gait Retraining |
| Progressive walking program | Active comparator | Participant receives 8 sessions of a graded walking program. Receives: Behavioral: Progressive Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
# of participants screened per month
Measured: through study completion, an average of 2 years
Enrollment rate
# of participants enrolled per month
Measured: through study completion, an average of 2 years
Retention
% participants that complete all study visits
Measured: through study completion, an average of 2 years
Secondary outcomes (7)
Withdrawals/Terminated
Proportion of participants who withdraw or terminated by investigators and reasons why
Measured: through study completion, an average of 2 years
Adverse events (AE)/Unanticipated problems (UP)
Proportion of participants with AE/UP
Measured: through study completion, an average of 2 years
Vertical average loading rate
Slope of the most linear portion of the vertical ground reaction force curve, during early stance.
Measured: Change from baseline to conclusion of intervention, an average of 1-month
Vertical instantaneous loading rate
Maximum slope of the most vertical portion of the vertical ground reaction force curve between successive data points, during early stance.
Measured: Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain with Activities
WOMAC questionnaire, pain sub scale 0-20
Measured: Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain Severity
Visual analog scale, 0-100
Measured: Change from baseline to conclusion of intervention, an average of 1-month
Pressure pain threshold
Assessed using hand held algometer
Measured: Change from baseline to conclusion of intervention, an average of 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start5 Nov 2019
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148807
- Sponsor's protocol ID
- 18-11-15
- Status last verified
- Sep 2022
- First submitted
- 29 Oct 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Corrigan P, Davis IS, James KA, Crossley KM, Stefanik JJ. Reducing knee pain and loading with a gait retraining program for individuals with knee osteoarthritis: Protocol for a randomized feasibility trial. Osteoarthr Cartil Open. 2020 Sep 3;2(4):100097. doi: 10.1016/j.ocarto.2020.100097. eCollection 2020 Dec.
PubMed 36474880
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Walking Intervention on Impact Loading and Pain
- ClinicalTrials.gov ID
- NCT04148807
- Acronym / sponsor ID
- 18-11-15
- Conditions
- Osteoarthritis, Knee, Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 4 Nov 2019 (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 study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.
Detailed description
Knee osteoarthritis (OA) is a chronic condition affecting ~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA.
At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold.
Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive walking program with gait retraining | Experimental | Behavioral: Progressive Walking with Gait RetrainingParticipant will receive 8 gait-retraining intervention sessions. |
| Progressive walking program | Active comparator | Behavioral: Progressive Walking ProgramParticipant receives 8 sessions of a graded walking program. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 45
- Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
- History of knee pain for at least 3 months
- Morning stiffness in the morning lasting less than 30 minutes
Key exclusion criteria (8 listed)
- Walk with an assistive device
- Current use of oral opiates or centrally acting pain medications
- History of lower extremity surgery
- Underwent an intra-articular knee joint injection in the past 3 months
- Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
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 |
|---|---|---|
| Progressive Walking with Gait RetrainingA progressive walking program with gait retraining will be performed on a treadmill at self-selected comfortable walking speed wearing an inertial measurement unit (IMU) on the medial aspect of the distal tibia. The (vertical) peak positive acceleration (PPA) of the tibia is a measure of tibial shock. Subjects will be provided real-time audio feedback to reduce PPA by 20% of their average peak PPA. During retraining sessions, a faded feedback approach will be used. Feedback will be provided continuously during the first four sessions and will be faded over the last 4 sessions. Walking time will increase over the 8 sessions. | Behavioural | Progressive walking program with gait retraining |
| Progressive Walking ProgramA progressive walking program will also be performed on a treadmill where subjects will walk at a self-selected comfortable speed with the same walking times per session as the retraining group without any feedback or retraining cues. | Behavioural | Progressive walking program |
Primary outcome
Recruitment rate
Time frame: through study completion, an average of 2 years
# of participants screened per month
Enrollment rate
Time frame: through study completion, an average of 2 years
# of participants enrolled per month
Retention
Time frame: through study completion, an average of 2 years
% participants that complete all study visits
7 secondary outcomes
Withdrawals/Terminated
Time frame: through study completion, an average of 2 years
Adverse events (AE)/Unanticipated problems (UP)
Time frame: through study completion, an average of 2 years
Vertical average loading rate
Time frame: Change from baseline to conclusion of intervention, an average of 1-month
Vertical instantaneous loading rate
Time frame: Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain with Activities
Time frame: Change from baseline to conclusion of intervention, an average of 1-month
Knee Pain Severity
Time frame: Change from baseline to conclusion of intervention, an average of 1-month
Pressure pain threshold
Time frame: Change from baseline to conclusion of intervention, an average of 1-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 36474880Corrigan P, Davis IS, James KA, Crossley KM, Stefanik JJ. Reducing knee pain and loading with a gait retraining program for individuals with knee osteoarthritis: Protocol for a randomized feasibility trial. Osteoarthr Cartil Open. 2020 Sep 3;2(4):100097. doi: 10.1016/j.ocarto.2020.100097. eCollection 2020 Dec.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Walking with Gait Retraining and Progressive Walking Program in people with Osteoarthritis, Knee and Knee Pain Chronic, run by Northeastern University at 1 site in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 29 Sep 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Stefanik, MSPT, PhD (6173738934, j.stefanik@northeastern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148807, which also lists 1 linked publication.
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 29 Sep 2022.