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
About this trial
This is an interventional other trial for Patellofemoral Pain
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
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
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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