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

Arthritis Knee Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03760380
• Other study ID #: OCR17682
• Status: Withdrawn
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: November 10, 2020

Study information

• Verified date: November 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee

Intervention

Device:
• Sole 1 - Neutral
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 - Offset
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 - Neutral
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 - Offset
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Scientific Motion Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	Baseline (Phase 1); Baseline (Phase 2), Week 4, Week 8, Week 12
Secondary	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).	Baseline (Phase 2), Week 4, Week 8, Week 12
Secondary	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.	Baseline (Phase 2), Week 4, Week 8, Week 12
Secondary	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.	Baseline (Phase 2), Week 4, Week 8, Week 12
Secondary	Change in Stair Climb time score.	Time it takes participant to walk up on flight of stairs (12 steps).	Baseline (Phase 2), Week 4, Week 8, Week 12