Patellofemoral Pain SyndromeNCT03285464
Utilizing the Trunk as a Proximal Lever to Strengthen the Hip Musculature and Alter Lower Extremity Function
A study testing Triplanar Rotary Resistance in people with Patellofemoral Pain Syndrome, run by High Point University at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Triplanar Rotary Resistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18> year old female; must be able to run on the treadmill for 5-7 min and perform a single leg squat
Who cannot join
- surgery to the LB or lower extremities Significant injury (seeking medical attention) to the LB or LEs in the last 6mos.
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point University
High Point, North Carolina, 27268
About this study
Official title: Investigating the Effects of a Triplanar Rotary Based Hip Focused Therapeutic Exercise Program on Dynamic Lower Extremity Alignment and Functional Performance
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?
Read the 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
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Triplanar Rotary Resistance
- Keywords
- knee, hip, exercise, proximal control, PFPS
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triplanar Rotary ResistanceOther
Also called Convention Hip Focused
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.
| Study group | Role | What they receive |
|---|---|---|
| Hip | Active comparator | This group will perform a known hip strengthening program Receives: Other: Triplanar Rotary Resistance |
| Trunk | Experimental | This group will use the trunk as a lever to strengthen the hip Receives: Other: Triplanar Rotary Resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hip Strength after a 12 week hip focused intervention
Isometric hand held dynamometer
Measured: Baseline measures at initial data collection; repeat post intervention measures at 6wks
Secondary outcomes (2)
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.
Measured: Baseline measures at initial data collection; repeat post intervention measures at 6wks
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.
Measured: Baseline measures at initial data collection; repeat post intervention measures at 6wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start9 Aug 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Wright, DPT, Principal investigator, HPUEric Hegedus, DPT, Study chair, HPUKevin Ford, PhD, Study director, HPU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285464
- Sponsor's protocol ID
- 201508-387
- Status last verified
- Feb 2018
- First submitted
- 12 Sep 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data collected will only be shared amongst the research team named in this protocol.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of a Triplanar Rotary Based Hip Focused Therapeutic Exercise Program on Dynamic Lower Extremity Alignment and Functional Performance
- ClinicalTrials.gov ID
- NCT03285464
- Acronym / sponsor ID
- 201508-387
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- knee, hip, exercise, proximal control, PFPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Hip | Active comparator | Other: Triplanar Rotary ResistanceThis group will perform a known hip strengthening program |
| Trunk | Experimental | Other: Triplanar Rotary ResistanceThis group will use the trunk as a lever to strengthen the hip |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18> year old female; must be able to run on the treadmill for 5-7 min and perform a single leg squat
Key exclusion criteria (1 listed)
- surgery to the LB or lower extremities Significant injury (seeking medical attention) to the LB or LEs in the last 6mos.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triplanar Rotary ResistanceAlso: Convention Hip FocusedTrunk 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. | Other | Hip, Trunk |
Primary outcome
Change in Hip Strength after a 12 week hip focused intervention
Time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks
Isometric hand held dynamometer
2 secondary outcomes
Biomechanical assessment of single leg squat
Time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks
Biomechanical Running Assessment
Time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: Undecided. The data collected will only be shared amongst the research team named in this protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Wright, DPT principal investigator
HPU
Eric Hegedus, DPT study chair
HPU
Kevin Ford, PhD study director
HPU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triplanar Rotary Resistance in people with Patellofemoral Pain Syndrome, run by High Point University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hip Strength after a 12 week hip focused intervention (time frame: Baseline measures at initial data collection; repeat post intervention measures at 6wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.