Gait Modification and Knee Joint Load

NCT04946136 | Suspended DMC

• 1 other identifier: STU00212048
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• External knee adduction moment during walking

  The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.

  Baseline-to-6-week change

• WOMAC (Western Ontario and McMaster Universities) score

  WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.

  Baseline-to-6-week change

Secondary Outcomes (2)

• External knee flexion moment during walking

  Baseline-to-6-week change

• KOOS (Knee Injury and Osteoarthritis Outcome Score)

  Baseline-to-6-week change

Study Arms (1)

Gait modification

EXPERIMENTAL

In this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill.

Other: Gait modification

Interventions

Gait modification OTHER

Individualized gait modifications guided by real-time visual feedback of knee load

Gait modification

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
• reporting average knee pain on walking \> 3 on an 11-point scale (0-10) in at least one knee
• pain or tenderness predominantly located on the medial knee.

You may not qualify if:

• medial TF joint space width greater than lateral
• Kellgren/Lawrence (K/L) grade 4
• knee surgery or intra-articular corticosteroid injection in the past 6 months
• uncomfortable walking on treadmill for 20 minutes
• unable to walk without a walking aide
• inflammatory arthritis
• other musculoskeletal or neurological disorders that affect gait patterns
• currently receiving physical therapy

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Alison H Chang

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a pilot single-arm study examining the effect of an intervention on biomechanical and symptomatic outcomes. There is no control group, therefore no masking employed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: January 11, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

US (1)