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

Not Applicable

Withdrawn

• Conditions: Arthritis Knee
• Interventions: Device: Sole 1 - Neutral; Device: Sole 1 - Offset; Device: Sole 2 - Neutral; Device: Sole 2 - Offset

• Registration Number: NCT03760380
• Lead Sponsor: University of Florida

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2019-04-16
• Status Verified: 2020-11
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-10
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1 Short Term	Sole 1 - Offset	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)
Phase 1 Short Term	Sole 2 - Offset	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)
Phase 1 Short Term	Sole 2 - Neutral	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)
Phase 1 Short Term	Sole 1 - Neutral	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)
Phase 2 Long Term	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.
Phase 2 Long Term	Sole 1 - 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.

Primary Outcome Measures

Name	Time	Method
Change in NRS pain (Pain Numeric Rating Scale) score.	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").

Secondary Outcome Measures

Name	Time	Method
Change in SF-36 disability score.	Baseline (Phase 2), Week 4, Week 8, Week 12	Eight scaled scores, where each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score	Baseline (Phase 2), Week 4, Week 8, Week 12	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 Stair Climb time score.	Baseline (Phase 2), Week 4, Week 8, Week 12	Time it takes participant to walk up on flight of stairs (12 steps).
Change in Timed Up & Go (TUG) Test score.	Baseline (Phase 2), Week 4, Week 8, Week 12	Time it takes for participant to rise from chair, walk 3 meters, turn around, walk back and sit down.