Utilizing the Trunk as a Proximal Lever to Strengthen the Hip Musculature and Alter Lower Extremity Function
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triplanar Rotary Resistance
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring knee, hip, exercise, proximal control, PFPS
Eligibility Criteria
Inclusion Criteria:
- 18> year old female; must be able to run on the treadmill for 5-7 min and perform a single leg squat
Exclusion Criteria:
- surgery to the LB or lower extremities Significant injury (seeking medical attention) to the LB or LEs in the last 6mos.
Sites / Locations
- High Point University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Hip
Trunk
Arm Description
This group will perform a known hip strengthening program
This group will use the trunk as a lever to strengthen the hip
Outcomes
Primary Outcome Measures
Change in Hip Strength after a 12 week hip focused intervention
Isometric hand held dynamometer
Secondary Outcome Measures
Biomechanical assessment of single leg squat
Subject squats on single leg and qualitative scoring is administered to determine the subjective amount of contralateral pelvic drop and femoral adduction to be described as dynamic knee valgus. The qualitative values will be binary in nature, whereas DKV is present or not.
Biomechanical Running Assessment
2/3D analysis of running gait following intervention; Utilizing both 3D/2D methods the measure of contralateral pelvic drop and the bisection of the patella will determine the amount of femoral adduction noted during running. The change in the femoral adduction angle after a 6 week intervention is the specific outcome measure to be obtained.
Full Information
NCT ID
NCT03285464
First Posted
September 12, 2017
Last Updated
February 23, 2018
Sponsor
High Point University
1. Study Identification
Unique Protocol Identification Number
NCT03285464
Brief Title
Utilizing the Trunk as a Proximal Lever to Strengthen the Hip Musculature and Alter Lower Extremity Function
Official Title
Investigating the Effects of a Triplanar Rotary Based Hip Focused Therapeutic Exercise Program on Dynamic Lower Extremity Alignment and Functional Performance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
High Point University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Does a rotary based triplanar exercise intervention that utilizes the trunk as a proximal lever, strengthen the hip and alter dynamic LE alignment in running females?
Detailed Description
Current hip-focused programs fail to alter hip adduction angles in females while performing higher speed and more complex maneuvers such as running.
(Willy, et al., 2011) - 10 female runners, underwent 6 wk. hip focused intervention, change in SLS but NO change in hip adduction angle while running.
A different intervention strategy that includes utilizing the trunk as the proximal lever to strengthen the hip, could potentially alter biomechanical outcomes such as hip adduction angles in female runners.
This study will apply a new intervention model and then measure running, single leg squat and hip strength to determine if a newly informed intervention can alter LE kinematics in females while running and make improvements in hip strength following the intervention Inclusion Criteria
18 years old or greater
Female Exclusion Criteria
Injury of the lumbar spine, hips, knees or foot/ankle in the last 6mos that required medical attention
any surgery of the lower back or the pelvis or lower extremities any time in the subjects life
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
knee, hip, exercise, proximal control, PFPS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will do current hip focused intervention published previously second group will receive a new hip intervention and then pre/post testing will take place for static and dynamic kinematics and hip strength
Masking
Participant
Masking Description
Only the subjects will not know which group they are being assigned to
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hip
Arm Type
Active Comparator
Arm Description
This group will perform a known hip strengthening program
Arm Title
Trunk
Arm Type
Experimental
Arm Description
This group will use the trunk as a lever to strengthen the hip
Intervention Type
Other
Intervention Name(s)
Triplanar Rotary Resistance
Other Intervention Name(s)
Convention Hip Focused
Intervention Description
Trunk group will strengthen the hip using the trunk as a lever to access the hip. The hip group will use femur as the lever to strengthen the hip.
Primary Outcome Measure Information:
Title
Change in Hip Strength after a 12 week hip focused intervention
Description
Isometric hand held dynamometer
Time Frame
Baseline measures at initial data collection; repeat post intervention measures at 6wks
Secondary Outcome Measure Information:
Title
Biomechanical assessment of single leg squat
Description
Subject squats on single leg and qualitative scoring is administered to determine the subjective amount of contralateral pelvic drop and femoral adduction to be described as dynamic knee valgus. The qualitative values will be binary in nature, whereas DKV is present or not.
Time Frame
Baseline measures at initial data collection; repeat post intervention measures at 6wks
Title
Biomechanical Running Assessment
Description
2/3D analysis of running gait following intervention; Utilizing both 3D/2D methods the measure of contralateral pelvic drop and the bisection of the patella will determine the amount of femoral adduction noted during running. The change in the femoral adduction angle after a 6 week intervention is the specific outcome measure to be obtained.
Time Frame
Baseline measures at initial data collection; repeat post intervention measures at 6wks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Include only females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18> year old female; must be able to run on the treadmill for 5-7 min and perform a single leg squat
Exclusion Criteria:
surgery to the LB or lower extremities Significant injury (seeking medical attention) to the LB or LEs in the last 6mos.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Wright, DPT
Organizational Affiliation
HPU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Hegedus, DPT
Organizational Affiliation
HPU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kevin Ford, PhD
Organizational Affiliation
HPU
Official's Role
Study Director
Facility Information:
Facility Name
High Point University
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27268
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data collected will only be shared amongst the research team named in this protocol.
Learn more about this trial
Utilizing the Trunk as a Proximal Lever to Strengthen the Hip Musculature and Alter Lower Extremity Function
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