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

NCT03760380 | Withdrawn FDA Device

• 1 other identifier: OCR17682
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthritis Knee

Keywords

osteoarthritis (OA); gait modifying shoe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) score

  Baseline (Phase 2), Week 4, Week 8, Week 12

• Change in SF-36 disability score.

  Baseline (Phase 2), Week 4, Week 8, Week 12

• Change in Timed Up & Go (TUG) Test score.

  Baseline (Phase 2), Week 4, Week 8, Week 12

• Change in Stair Climb time score.

  Baseline (Phase 2), Week 4, Week 8, Week 12

Study Arms (2)

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)

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.

Device: Sole 1 - Offset; Device: Sole 2 - Offset

Interventions

Sole 1 - Neutral DEVICE

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.

Phase 1 Short Term

Sole 1 - Offset DEVICE

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.

Phase 1 Short Term; Phase 2 Long Term

Sole 2 - Neutral DEVICE

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.

Phase 1 Short Term

Sole 2 - Offset DEVICE

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.

Phase 1 Short Term; Phase 2 Long Term

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Scientific Motion Technologies, Inc.: collaborator

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hari K Parvataneni

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: April 16, 2019
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share