- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05285007
Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain
April 8, 2024 updated by: Loma Linda University
Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain: Interventions and Outcomes in a Randomized Clinical Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Everett Lohman, DSc
- Phone Number: 83171 909-558-4632
- Email: elohman@llu.edu
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Recruiting
- Loma Linda University
-
Contact:
- Everett Lohman, DSc
- Phone Number: 83171 909-558-4632
- Email: elohman@llu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primary Intervention Group
The experimental group will receive two interventions to increase dorsiflexion range of motion.
|
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.
|
Active Comparator: Minimal Intervention Group
The minimal intervention group will read and infographic and complete 5 minutes of treadmill walking.
|
Participants ankle will not be taped and they will walk on the treadmill for 5 minutes and receive education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight bearing lunge test
Time Frame: change between baseline and post intervention on Day 1
|
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.
|
change between baseline and post intervention on Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patellofemoral Disability Index
Time Frame: change between baseline and post intervention on Day 1
|
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.
|
change between baseline and post intervention on Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Everett Lohman, Dsc, Loma Linda University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2022
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
March 8, 2022
First Submitted That Met QC Criteria
March 15, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5220026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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