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Effectiveness of a Walking Intervention on Impact Loading and Pain

Primary Purpose

Osteoarthritis, Knee, Knee Pain Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Walking with Gait Retraining
Progressive Walking Program
Sponsored by
Northeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with a clinical definition of knee OA using NICE guidelines:

  • Age ≥ 45
  • Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
  • History of knee pain for at least 3 months
  • Morning stiffness in the morning lasting less than 30 minutes

Exclusion Criteria:

  • Walk with an assistive device
  • Current use of oral opiates or centrally acting pain medications
  • History of lower extremity surgery
  • Underwent an intra-articular knee joint injection in the past 3 months
  • Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
  • Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study
  • Currently pregnant
  • Skin allergies to adhesives

Sites / Locations

  • Northeastern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive walking program with gait retraining

Progressive walking program

Arm Description

Participant will receive 8 gait-retraining intervention sessions.

Participant receives 8 sessions of a graded walking program.

Outcomes

Primary Outcome Measures

Recruitment rate
# of participants screened per month
Enrollment rate
# of participants enrolled per month
Retention
% participants that complete all study visits

Secondary Outcome Measures

Withdrawals/Terminated
Proportion of participants who withdraw or terminated by investigators and reasons why
Adverse events (AE)/Unanticipated problems (UP)
Proportion of participants with AE/UP
Vertical average loading rate
Slope of the most linear portion of the vertical ground reaction force curve, during early stance.
Vertical instantaneous loading rate
Maximum slope of the most vertical portion of the vertical ground reaction force curve between successive data points, during early stance.
Knee Pain with Activities
WOMAC questionnaire, pain sub scale 0-20
Knee Pain Severity
Visual analog scale, 0-100
Pressure pain threshold
Assessed using hand held algometer

Full Information

First Posted
October 29, 2019
Last Updated
September 27, 2022
Sponsor
Northeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT04148807
Brief Title
Effectiveness of a Walking Intervention on Impact Loading and Pain
Official Title
Effectiveness of a Walking Intervention on Impact Loading and Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.
Detailed Description
Knee osteoarthritis (OA) is a chronic condition affecting ~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA. At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold. Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Knee Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progressive walking program with gait retraining
Arm Type
Experimental
Arm Description
Participant will receive 8 gait-retraining intervention sessions.
Arm Title
Progressive walking program
Arm Type
Active Comparator
Arm Description
Participant receives 8 sessions of a graded walking program.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Walking with Gait Retraining
Intervention Description
A progressive walking program with gait retraining will be performed on a treadmill at self-selected comfortable walking speed wearing an inertial measurement unit (IMU) on the medial aspect of the distal tibia. The (vertical) peak positive acceleration (PPA) of the tibia is a measure of tibial shock. Subjects will be provided real-time audio feedback to reduce PPA by 20% of their average peak PPA. During retraining sessions, a faded feedback approach will be used. Feedback will be provided continuously during the first four sessions and will be faded over the last 4 sessions. Walking time will increase over the 8 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Walking Program
Intervention Description
A progressive walking program will also be performed on a treadmill where subjects will walk at a self-selected comfortable speed with the same walking times per session as the retraining group without any feedback or retraining cues.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
# of participants screened per month
Time Frame
through study completion, an average of 2 years
Title
Enrollment rate
Description
# of participants enrolled per month
Time Frame
through study completion, an average of 2 years
Title
Retention
Description
% participants that complete all study visits
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Withdrawals/Terminated
Description
Proportion of participants who withdraw or terminated by investigators and reasons why
Time Frame
through study completion, an average of 2 years
Title
Adverse events (AE)/Unanticipated problems (UP)
Description
Proportion of participants with AE/UP
Time Frame
through study completion, an average of 2 years
Title
Vertical average loading rate
Description
Slope of the most linear portion of the vertical ground reaction force curve, during early stance.
Time Frame
Change from baseline to conclusion of intervention, an average of 1-month
Title
Vertical instantaneous loading rate
Description
Maximum slope of the most vertical portion of the vertical ground reaction force curve between successive data points, during early stance.
Time Frame
Change from baseline to conclusion of intervention, an average of 1-month
Title
Knee Pain with Activities
Description
WOMAC questionnaire, pain sub scale 0-20
Time Frame
Change from baseline to conclusion of intervention, an average of 1-month
Title
Knee Pain Severity
Description
Visual analog scale, 0-100
Time Frame
Change from baseline to conclusion of intervention, an average of 1-month
Title
Pressure pain threshold
Description
Assessed using hand held algometer
Time Frame
Change from baseline to conclusion of intervention, an average of 1-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a clinical definition of knee OA using NICE guidelines: Age ≥ 45 Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible History of knee pain for at least 3 months Morning stiffness in the morning lasting less than 30 minutes Exclusion Criteria: Walk with an assistive device Current use of oral opiates or centrally acting pain medications History of lower extremity surgery Underwent an intra-articular knee joint injection in the past 3 months Suffer from inflammatory arthritis or other conditions that affect lower extremity functions Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study Currently pregnant Skin allergies to adhesives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Stefanik, MSPT, PhD
Phone
6173738934
Email
j.stefanik@northeastern.edu
Facility Information:
Facility Name
Northeastern University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Stefanik, MSPT, PhD

12. IPD Sharing Statement

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Effectiveness of a Walking Intervention on Impact Loading and Pain

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