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Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain

Primary Purpose

Patellofemoral Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobilization with Movement
No mobilization with movement and education
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patellofemoral Pain

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • History of active Patellofemoral Pain for at least 6 months
  • No clinic based therapeutic interventions for a 6-month period prior to testing
  • Females aged 18-59 years' old
  • Limited ankle dorsiflexion as noted by <45degs using the weight bearing lunge test

Exclusion Criteria:

  • History of musculoskeletal surgery or fractures on the tested leg or lumbar spine that could affect their biomechanics during the study
  • History of soft tissue or skeletal abnormalities in the tested limb
  • Current knee effusion
  • Resting pain greater than 5/10

Sites / Locations

  • Loma Linda UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primary Intervention Group

Minimal Intervention Group

Arm Description

The experimental group will receive two interventions to increase dorsiflexion range of motion.

The minimal intervention group will read and infographic and complete 5 minutes of treadmill walking.

Outcomes

Primary Outcome Measures

Weight bearing lunge test
This test is used to assess a participant's available dorsiflexion range of motion in a weight bearing position. Furthermore, this places the participants hip, knee, and ankle into a flexed position which correlates with the squat tests we will be using.

Secondary Outcome Measures

Patellofemoral Disability Index
The Index is a self-reported questionnaire that addresses the amount of pain a person may have during tasks such as running, jumping, and stair climbing.

Full Information

First Posted
March 8, 2022
Last Updated
March 28, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05285007
Brief Title
Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain
Official Title
Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain: Interventions and Outcomes in a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this graduate student research study is to investigate the relationship between limited ankle dorsiflexion and the potential effects on a single limb squat task in the Patellofemoral/Knee Pain population.
Detailed Description
Participants will undergo Covid screening prior to filling out consent form and PHI. Randomization will occur to create an experimental group and a minimal intervention group. Participants will complete two self-reported questionnaires on how their diagnosis affects functional activities. Dorsiflexion range of motion in a weight bearing position will be taken. Hip abductor strength on tested limb will be measure on isokinetic device. The Lateral Step Down test will be conducted for 6 trials on each participant, 3 with a heel wedge and 3 without, movement recorded, and graded using two motion capture devices. The experimental group will receive two interventions to increase dorsiflexion range of motion. The minimal intervention group will read and infographic and complete 5 minutes of treadmill walking. Each participant will then have their dorsiflexion measured again prior to completing another 3 trials of the Lateral Step Down test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Intervention Group
Arm Type
Experimental
Arm Description
The experimental group will receive two interventions to increase dorsiflexion range of motion.
Arm Title
Minimal Intervention Group
Arm Type
Active Comparator
Arm Description
The minimal intervention group will read and infographic and complete 5 minutes of treadmill walking.
Intervention Type
Other
Intervention Name(s)
Mobilization with Movement
Intervention Description
Participants will be lunging on a box with posterior ankle glide of 10 seconds times 5 sets. They will have 30 seconds rest between trials. Participant will have their ankle taped and then walk on a treadmill at a self-selected pace for 5 minutes.
Intervention Type
Other
Intervention Name(s)
No mobilization with movement and education
Intervention Description
Participants ankle will not be taped and they will walk on the treadmill for 5 minutes and receive education.
Primary Outcome Measure Information:
Title
Weight bearing lunge test
Description
This test is used to assess a participant's available dorsiflexion range of motion in a weight bearing position. Furthermore, this places the participants hip, knee, and ankle into a flexed position which correlates with the squat tests we will be using.
Time Frame
change between baseline and post intervention on Day 1
Secondary Outcome Measure Information:
Title
Patellofemoral Disability Index
Description
The Index is a self-reported questionnaire that addresses the amount of pain a person may have during tasks such as running, jumping, and stair climbing.
Time Frame
change between baseline and post intervention on Day 1

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History of active Patellofemoral Pain for at least 6 months No clinic based therapeutic interventions for a 6-month period prior to testing Females aged 18-59 years' old Limited ankle dorsiflexion as noted by <45degs using the weight bearing lunge test Exclusion Criteria: History of musculoskeletal surgery or fractures on the tested leg or lumbar spine that could affect their biomechanics during the study History of soft tissue or skeletal abnormalities in the tested limb Current knee effusion Resting pain greater than 5/10
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Everett Lohman, DSc
Phone
909-558-4632
Ext
83171
Email
elohman@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Lohman, Dsc
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Everett Lohman, DSc
Phone
909-558-4632
Ext
83171
Email
elohman@llu.edu

12. IPD Sharing Statement

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Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain

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