Gait Modification and Knee Joint Load

NCT ID: NCT04946136

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2024-06-30

Brief Summary

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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).

Detailed Description

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This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Gait modification

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.

Group Type EXPERIMENTAL

Gait modification

Intervention Type OTHER

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

Interventions

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Gait modification

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Alison Chang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison H Chang

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00212048

Identifier Type: -

Identifier Source: org_study_id

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