Arthritis KneeNCT03760380
Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions
A study testing Sole 1 - Neutral, Sole 1 - Offset and Sole 2 - Neutral in people with Arthritis Knee, run by University of Florida.
Trial summary
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Sole 1 - Neutral, Sole 1 - Offset and Sole 2 - Neutral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2019to 10 Nov 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic, OA-related knee pain
- Diagnosis of medial compartment knee OA (unilateral or bilateral)
- Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity
- Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray within the last 2 years prior to enrollment
- Able to walk unassisted for at least 10 minutes at a time
- Wear a Women's shoe size of 6.5 to 13 or a Men's shoe size of 5 to 12.
Who cannot join
- Patients suffering from acute septic or inflammatory arthritis
- Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that would preclude exercise in moderate duration, moderate workload trials
- Received a corticosteroid injection or invasive procedures within prior 6 months of the study
- History of avascular necrosis in the knee
- History of knee buckling
- Joint replacement in any lower extremity joint that has not optimally recovered (e.g. still causes significant pain or affects mobility) as determined by the PI.
Show all 16Show fewer
- Experienced more than 3 falls within the last year
- Currently using any knee brace on a regular basis for the knee pain, with the exception of basic knee sleeves
- Pathological osteoporotic fracture
- Severe symptomatic degenerative arthritis in lower limb joints other than the knees
- Severe back pain, prior spinal fusion or spinal deformity that would affect gait
- Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer
- Knee flexion contracture greater than 15°
- Knee flexion of less than 90°
- Any major injury to either knee within the prior 12 months
- Currently enrolled in a supervised physical therapy program
About this study
Official title: Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.
Read the detailed description
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis.
The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.
- Conditions
- Arthritis Knee
- Being tested
- Sole 1 - Neutral, Sole 1 - Offset, Sole 2 - Neutral, Sole 2 - Offset
- Keywords
- osteoarthritis (OA), gait modifying shoe
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sole 1 - NeutralDevice
Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability.
Sole 1 - OffsetDevice
Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
Sole 2 - NeutralDevice
Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability.
Sole 2 - OffsetDevice
Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Short Term | Experimental | Participants will serve as their own control. Questionnaires and gait measures will be collected during an initial visit using the experimental shoe device. All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset) Receives: Device: Sole 1 - Neutral; Device: Sole 1 - Offset; Device: Sole 2 - Neutral; Device: Sole 2 - Offset |
| Phase 2 Long Term | Experimental | Participants will serve as their own control. Questionnaires, balance, functional and gait measures will be collected during four different visits over a twelve week period (once at baseline visit, 4, 8, and 12 week visits) using the experimental shoe device. Patients will also complete a home walking program using the shoe device over the twelve week period. Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use. Receives: Device: Sole 1 - Offset; Device: Sole 2 - Offset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS pain (Pain Numeric Rating Scale) score.
Participants selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as one can imagine" or "worst pain imaginable").
Measured: Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
Secondary outcomes (4)
Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
Self-administered questionnaire consisting of 24 items divided into 3 subscales [total score 0-96; subscales from 0-20 (pain)/0-8(stiffness)/0-68(physical function)]. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: Baseline (Phase 2), Week 4, Week 8, Week 12
Change in SF-36 disability score.
Eight scaled scores, where each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
Measured: Baseline (Phase 2), Week 4, Week 8, Week 12
Change in Timed Up & Go (TUG) Test score.
Time it takes for participant to rise from chair, walk 3 meters, turn around, walk back and sit down.
Measured: Baseline (Phase 2), Week 4, Week 8, Week 12
Change in Stair Climb time score.
Time it takes participant to walk up on flight of stairs (12 steps).
Measured: Baseline (Phase 2), Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start16 Apr 2019 (estimated)
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Why it stopped: sponsor funding shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1 All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset) Phase 2 Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Motion Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Hari K Parvataneni, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760380
- Sponsor's protocol ID
- OCR17682
- Status last verified
- Nov 2020
- First submitted
- 29 Nov 2018
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions on Knee Osteoarthritis Acutely and Over a 12 Week Period
- ClinicalTrials.gov ID
- NCT03760380
- Acronym / sponsor ID
- OCR17682
- Conditions
- Arthritis Knee
- Keywords
- osteoarthritis (OA), gait modifying shoe
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor funding shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Scientific Motion Technologies, Inc.
- Study start
- 16 Apr 2019 (estimated)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 30 Nov 2018 (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 involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.
Detailed description
This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis.
The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset) Phase 2 Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Short Term | Experimental | Device: Sole 1 - Neutral, Device: Sole 1 - Offset, Device: Sole 2 - Neutral, Device: Sole 2 - OffsetParticipants will serve as their own control. Questionnaires and gait measures will be collected during an initial visit using the experimental shoe device. All subjects will perform the same procedures with all the experimental interventions (Sole 1 - Neutral, Sole 1--Offset, Sole 2 - Neutral, Sole 2 - Offset) |
| Phase 2 Long Term | Experimental | Device: Sole 1 - Offset, Device: Sole 2 - OffsetParticipants will serve as their own control. Questionnaires, balance, functional and gait measures will be collected during four different visits over a twelve week period (once at baseline visit, 4, 8, and 12 week visits) using the experimental shoe device. Patients will also complete a home walking program using the shoe device over the twelve week period. Subjects will be assigned one of two shoes/soles (either Sole 1-Offset or Sole 2- Offset) for home use. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic, OA-related knee pain
- Diagnosis of medial compartment knee OA (unilateral or bilateral)
- Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity
- Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray within the last 2 years prior to enrollment
- Able to walk unassisted for at least 10 minutes at a time
Key exclusion criteria (16 listed)
- Patients suffering from acute septic or inflammatory arthritis
- Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that would preclude exercise in moderate duration, moderate workload trials
- Received a corticosteroid injection or invasive procedures within prior 6 months of the study
- History of avascular necrosis in the knee
- History of knee buckling
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 |
|---|---|---|
| Sole 1 - NeutralAppropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability. | Device | Phase 1 Short Term |
| Sole 1 - OffsetAppropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position. | Device | Phase 1 Short Term, Phase 2 Long Term |
| Sole 2 - NeutralAppropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability. | Device | Phase 1 Short Term |
| Sole 2 - OffsetAppropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position. | Device | Phase 1 Short Term, Phase 2 Long Term |
Primary outcome
Change in NRS pain (Pain Numeric Rating Scale) score.
Time frame: Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
Participants selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as one can imagine" or "worst pain imaginable").
4 secondary outcomes
Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
Time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
Change in SF-36 disability score.
Time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
Change in Timed Up & Go (TUG) Test score.
Time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
Change in Stair Climb time score.
Time frame: Baseline (Phase 2), Week 4, Week 8, Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 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.
Hari K Parvataneni principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Sole 1 - Neutral, Sole 1 - Offset and Sole 2 - Neutral in people with Arthritis Knee, run by University of Florida.
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 16 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: withdrawn, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 NRS pain (Pain Numeric Rating Scale) score. (time frame: Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12). 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 12 Nov 2020.