Using Pressure Detecting Insoles to Reduce Knee Loading

NCT02955225 | Completed Results

• 1 other identifier: AF-6477
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether use of a pressure-detecting shoe improve can enhance favorable loading conditions at the knee.

Conditions

Knee Osteoarthritis

Keywords

Knee loads; Knee adduction moment; Biomechanical intervention; Insole; Shoe

Outcome Measures

Primary Outcomes (1)

• Change in Knee Adduction Moment Relative to Baseline

  Surrogate marker of medial knee loading, measured using 3D motion analysis, with initial SI units in Newton\*meters, and normalized to the individual's body weight and height, resulting in measurement units (% bodyweight \* height). To assess changes in loading at the knee between baseline and the three post-baseline measurements (Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training), participants underwent gait analysis in a motion analysis laboratory using force plates and optoelectric cameras to quantify the joint moments in three directions. This study focused on the change in joint moment in the frontal plane. After training with an active insole, we would expect reductions in the frontal plane knee joint moment. Generally speaking, lower moments are better and a negative change is desired.

  Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training

Secondary Outcomes (4)

• Change in Moment Lever-arm for KAM

  Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training

• Change in SPEED

  Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training

• Change in Knee Pain

  after 3 weeks of ongoing training, after 6 weeks of ongoing training

• Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training

  after 3 weeks of ongoing training, after 6 weeks of ongoing training

Study Arms (2)

Flexible shoe with Active Insole

EXPERIMENTAL

Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).

Device: Active Moticon OpenGO insole

Flexible shoe with Passive Insole

ACTIVE COMPARATOR

A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.

Device: Passive shoe insole

Interventions

Active Moticon OpenGO insole DEVICE

A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.

Flexible shoe with Active Insole

Passive shoe insole DEVICE

A deactivated insole measures shoe pressure only.

Flexible shoe with Passive Insole

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give informed consent and comply with the study protocol.
• Symptomatic OA of the knee greater than 3 months, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified as more symptomatic will serve as the index knee.
• Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC).
• Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.
• Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
• Able to walk at least 10 minutes without a break.
• Age of 40 years or older

You may not qualify if:

• Unwillingness to wear study shoes for at least 6 hours/day for 6 days of the week
• Knee flexion contracture of \> 15 degrees or inability to ambulate without assistance.
• Presence of clinical OA of the ankle or hip or ankle/hip pain\>10 mm (WOMAC).
• Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either knee.
• Concurrent systemic inflammatory arthropathy
• Prior knee or hip arthroplasty, or surgical arthroscopy within the previous 3 months.
• Intrinsic foot disease: hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated particular footwear.
• Intra-articular knee injection: steroids within 6 wks, hyaluronan derivatives within 4 mos.
• Body mass index greater than 38.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Arthritis Foundation: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Since the goal of this proof-of-concept study was to evaluate feedback gait modification in individuals with knee OA, the study was primarily powered to determine KAM changes before and after the intervention and underpowered for comparison with another intervention.

Results Point of Contact

• Title: Dr. Markus Wimmer, Director Motion Analysis Laboratory
• Organization: Rush University Medical Center

markus_a_wimmer@rush.edu

(312) 942 2789

Study Officials

• Markus Wimmer, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2016
• First Posted: November 4, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 3, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Dec 31, 2021
• Access Criteria: Sharing access through the Arthritis Foundation

Locations

US (1)