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Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions

Primary Purpose

Arthritis Knee

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sole 1 - Neutral
Sole 1 - Offset
Sole 2 - Neutral
Sole 2 - Offset
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Arthritis Knee focused on measuring osteoarthritis (OA), gait modifying shoe

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Phase 1 Short Term

    Phase 2 Long Term

    Arm Description

    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)

    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.

    Outcomes

    Primary Outcome Measures

    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").

    Secondary Outcome Measures

    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).
    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.
    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.
    Change in Stair Climb time score.
    Time it takes participant to walk up on flight of stairs (12 steps).

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    November 10, 2020
    Sponsor
    University of Florida
    Collaborators
    Scientific Motion Technologies, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03760380
    Brief Title
    Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    sponsor funding shortage
    Study Start Date
    April 16, 2019 (Anticipated)
    Primary Completion Date
    November 10, 2020 (Actual)
    Study Completion Date
    November 10, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    Scientific Motion Technologies, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis Knee
    Keywords
    osteoarthritis (OA), gait modifying shoe

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 1 Short Term
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Phase 2 Long Term
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sole 1 - Neutral
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sole 1 - Offset
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sole 2 - Neutral
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sole 2 - Offset
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in NRS pain (Pain Numeric Rating Scale) score.
    Description
    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").
    Time Frame
    Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
    Secondary Outcome Measure Information:
    Title
    Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score
    Description
    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).
    Time Frame
    Baseline (Phase 2), Week 4, Week 8, Week 12
    Title
    Change in SF-36 disability score.
    Description
    Eight scaled scores, where each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
    Time Frame
    Baseline (Phase 2), Week 4, Week 8, Week 12
    Title
    Change in Timed Up & Go (TUG) Test score.
    Description
    Time it takes for participant to rise from chair, walk 3 meters, turn around, walk back and sit down.
    Time Frame
    Baseline (Phase 2), Week 4, Week 8, Week 12
    Title
    Change in Stair Climb time score.
    Description
    Time it takes participant to walk up on flight of stairs (12 steps).
    Time Frame
    Baseline (Phase 2), Week 4, Week 8, Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hari K Parvataneni
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions

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