Movement, AbnormalNCT06260306
Hip Activation vs. Hip Activation + Core Stabilization
A study testing Hip activation home exercise program and Hip activation plus core stabilization home exercise program in people with Movement, Abnormal and Lower Extremity Problem, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Movement, Abnormal, Lower Extremity Problem
- What is being tested?
- Hip activation home exercise program and Hip activation plus core stabilization home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2024to 12 Apr 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be current first- or second-year Doctor of Physical Therapy (DPT) students in the School of Allied Health Professions (SAHP) at Louisiana State University Health Shreveport over the age of 21.
Who cannot join
- Current pain or pathology in either LE which currently limits their ability to perform the FSDT or drop landing task, a history of low back pain in the last three months, known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (DRA) which may be exacerbated by participation in the intervention and could be a confounding variable, and current participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
About this study
Official title: Comparison of a Hip Activation Versus a Combined Hip Activation and Core Stabilization Program on Improving Lower Extremity Function: A Single-Blind Randomized Controlled Trial
The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.
Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP.
Read more
Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.
Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.
Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG.
- Conditions
- Movement, Abnormal, Lower Extremity Problem
- Being tested
- Hip activation home exercise program, Hip activation plus core stabilization home exercise program
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip activation home exercise programOther
The hip activation HEP group will receive a combination of hip musculature activation exercises used by previous researchers that show an increase in hip muscle recruitment. Each participant will perform their respective intervention program at home twice weekly for eight weeks.
Hip activation plus core stabilization home exercise programOther
The hip activation plus core stabilization HEP group will receive the same hip exercises, plus core stabilization exercises used by previous researchers. Each participant will perform their respective intervention program at home twice weekly for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hip Activation Group | Active comparator | The hip activation HEP group will receive a combination of hip musculature activation exercises used by previous researchers that show an increase in hip muscle recruitment. Receives: Other: Hip activation home exercise program |
| Combined Hip Activation and Core Stabilization Group | Experimental | The hip activation plus core stabilization HEP group will receive the same hip exercises as the other group, plus core stabilization exercises used by previous researchers. Receives: Other: Hip activation plus core stabilization home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forward Step Down Test (FSDT)
Rating on the FSDT (0-6; 0-1 = good movement quality, 2-3 = moderate movement quality, 4 or more = poor movement quality).
Measured: Pre- and post-eight week intervention
Secondary outcomes (11)
Maximal volitional isometric contraction (MVIC) via sensory electromyography (sEMG) of gluteus maximus (GMax)
MVIC (microvolts) of GMax during performance of the FSDT
Measured: Pre- and post-eight week intervention
Mean activation of GMax via sEMG
Mean activation (% MVIC) of GMax during performance of the FSDT
Measured: Pre- and post-eight week intervention
Peak activation of GMax via sEMG
Peak activation (%MVIC) of GMax during performance of the FSDT
Measured: Pre- and post-eight week intervention
MVIC via sEMG of gluteus medius (GMed)
MVIC (microvolts) of GMed during performance of the FSDT
Measured: Pre- and post-eight week intervention
Mean activation of GMed via sEMG
Mean activation (% MVIC) of GMed during performance of the FSDT
Measured: Pre- and post-eight week intervention
Peak activation of GMed via sEMG
Peak activation (% MVIC) of GMed during performance of the FSDT
Measured: Pre- and post-eight week intervention
MVIC via of transversus abdominis (TA)
MVIC (microvolts) of TA during performance of the FSDT
Measured: Pre- and post-eight week intervention
Mean activation of TA via sEMG
Mean activation (% MVIC) of TA during performance of the FSDT
Measured: Pre- and post-eight week intervention
Peak activation of TA via sEMG
Peak activation (% MVIC) of TA during performance of FSDT
Measured: Pre- and post-eight week intervention
Peak external knee abduction moment during drop landing task
Kinetic assessment of the peak external knee abduction moment (Nm/kg) during the drop landing task
Measured: Pre- and post-eight week intervention
Compliance with Home Exercise Program
Self-reported completion of each HEP session will be recorded by the participant and then returned to the investigators post-completion
Measured: Post-eight week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start24 Jan 2024
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Movement, AbnormalStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel W. Flowers, PT, DPT, PhD, Principal investigator, LSU Health Sciences Center at Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260306
- Sponsor's protocol ID
- STUDY00002568
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark L, Dean A, Mitchell A, & Torgerson DJ. Envelope use and reporting in randomised controlled trials: a guide for researchers. Research Methods in Medicine & Health Sciences. 2021;2(1):2-11. doi:10.1177/2632084320957204
Konrad P. The ABC of EMG: A Practical Introduction to Kinesiological Electromyography. Noraxon U.S.A.; 2006.
Gage BE, McIlvain NM, Collins CL, Fields SK, Comstock RD. Epidemiology of 6.6 million knee injuries presenting to United States emergency departments from 1999 through 2008. Acad Emerg Med. 2012 Apr;19(4):378-85. doi: 10.1111/j.1553-2712.2012.01315.x.
PubMed 22506941Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.
PubMed 22147711Bolgla LA, Boling MC, Mace KL, DiStefano MJ, Fithian DC, Powers CM. National Athletic Trainers' Association Position Statement: Management of Individuals With Patellofemoral Pain. J Athl Train. 2018 Sep;53(9):820-836. doi: 10.4085/1062-6050-231-15.
PubMed 30372640Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
PubMed 20118526Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647.
PubMed 14669960Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.
PubMed 15179160Huxel Bliven KC, Anderson BE. Core stability training for injury prevention. Sports Health. 2013 Nov;5(6):514-22. doi: 10.1177/1941738113481200.
PubMed 24427426Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.
PubMed 32669487Flowers DW, Brewer W, Mitchell K, Ellison J, Frilot C. The Effect of Core Stabilization Training on Improving Gait and Self-Perceived Function in Patients with Knee Osteoarthritis: A Single-Arm Clinical Trial. Pathophysiology. 2022 Sep 1;29(3):495-506. doi: 10.3390/pathophysiology29030040.
PubMed 36136067McCallister E, Flowers D. Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. Internet Journal of Allied Health Sciences and Practice. Published online 2020. doi:https://doi.org/10.46743/1540-580x/2020.1931
Flowers DW, Brewer W, Ellison J, Mitchell K, Frilot C. Transversus abdominis activation does not alter gait impairments in patients with and without knee osteoarthritis. Clin Biomech (Bristol). 2021 Feb;82:105270. doi: 10.1016/j.clinbiomech.2020.105270. Epub 2021 Jan 1.
PubMed 33421757Cannon J, Weithman BA, Powers CM. Activation training facilitates gluteus maximus recruitment during weight-bearing strengthening exercises. J Electromyogr Kinesiol. 2022 Apr;63:102643. doi: 10.1016/j.jelekin.2022.102643. Epub 2022 Feb 9.
PubMed 35189569Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater Reliability of Functional Performance Tests for Subjects With Patellofemoral Pain Syndrome. J Athl Train. 2002 Sep;37(3):256-261.
PubMed 12937582
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Hip Activation Versus a Combined Hip Activation and Core Stabilization Program on Improving Lower Extremity Function: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06260306
- Acronym / sponsor ID
- STUDY00002568
- Conditions
- Movement, Abnormal, Lower Extremity Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 15 Feb 2024 (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.
The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.
Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP.
Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.
Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.
Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Activation Group | Active comparator | Other: Hip activation home exercise programThe hip activation HEP group will receive a combination of hip musculature activation exercises used by previous researchers that show an increase in hip muscle recruitment. |
| Combined Hip Activation and Core Stabilization Group | Experimental | Other: Hip activation plus core stabilization home exercise programThe hip activation plus core stabilization HEP group will receive the same hip exercises as the other group, plus core stabilization exercises used by previous researchers. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be current first- or second-year Doctor of Physical Therapy (DPT) students in the School of Allied Health Professions (SAHP) at Louisiana State University Health Shreveport over the age of 21.
Key exclusion criteria (1 listed)
- Current pain or pathology in either LE which currently limits their ability to perform the FSDT or drop landing task, a history of low back pain in the last three months, known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (DRA) which may be exacerbated by participation in the intervention and could be a confounding variable, and current participation in other clinical trials.
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 |
|---|---|---|
| Hip activation home exercise programThe hip activation HEP group will receive a combination of hip musculature activation exercises used by previous researchers that show an increase in hip muscle recruitment. Each participant will perform their respective intervention program at home twice weekly for eight weeks. | Other | Hip Activation Group |
| Hip activation plus core stabilization home exercise programThe hip activation plus core stabilization HEP group will receive the same hip exercises, plus core stabilization exercises used by previous researchers. Each participant will perform their respective intervention program at home twice weekly for eight weeks. | Other | Combined Hip Activation and Core Stabilization Group |
Primary outcome
Forward Step Down Test (FSDT)
Time frame: Pre- and post-eight week intervention
Rating on the FSDT (0-6; 0-1 = good movement quality, 2-3 = moderate movement quality, 4 or more = poor movement quality).
11 secondary outcomes
Maximal volitional isometric contraction (MVIC) via sensory electromyography (sEMG) of gluteus maximus (GMax)
Time frame: Pre- and post-eight week intervention
Mean activation of GMax via sEMG
Time frame: Pre- and post-eight week intervention
Peak activation of GMax via sEMG
Time frame: Pre- and post-eight week intervention
MVIC via sEMG of gluteus medius (GMed)
Time frame: Pre- and post-eight week intervention
Mean activation of GMed via sEMG
Time frame: Pre- and post-eight week intervention
Peak activation of GMed via sEMG
Time frame: Pre- and post-eight week intervention
MVIC via of transversus abdominis (TA)
Time frame: Pre- and post-eight week intervention
Mean activation of TA via sEMG
Time frame: Pre- and post-eight week intervention
Peak activation of TA via sEMG
Time frame: Pre- and post-eight week intervention
Peak external knee abduction moment during drop landing task
Time frame: Pre- and post-eight week intervention
Compliance with Home Exercise Program
Time frame: Post-eight week intervention
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 Apr 2024.
- BackgroundClark L, Dean A, Mitchell A, & Torgerson DJ. Envelope use and reporting in randomised controlled trials: a guide for researchers. Research Methods in Medicine & Health Sciences. 2021;2(1):2-11. doi:10.1177/2632084320957204
- BackgroundKonrad P. The ABC of EMG: A Practical Introduction to Kinesiological Electromyography. Noraxon U.S.A.; 2006.
- Results publication: PubMed 22506941Gage BE, McIlvain NM, Collins CL, Fields SK, Comstock RD. Epidemiology of 6.6 million knee injuries presenting to United States emergency departments from 1999 through 2008. Acad Emerg Med. 2012 Apr;19(4):378-85. doi: 10.1111/j.1553-2712.2012.01315.x.
- Results publication: PubMed 22147711Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.
- Results publication: PubMed 30372640Bolgla LA, Boling MC, Mace KL, DiStefano MJ, Fithian DC, Powers CM. National Athletic Trainers' Association Position Statement: Management of Individuals With Patellofemoral Pain. J Athl Train. 2018 Sep;53(9):820-836. doi: 10.4085/1062-6050-231-15.
- Results publication: PubMed 20118526Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
- Results publication: PubMed 14669960Mascal CL, Landel R, Powers C. Management of patellofemoral pain targeting hip, pelvis, and trunk muscle function: 2 case reports. J Orthop Sports Phys Ther. 2003 Nov;33(11):647-60. doi: 10.2519/jospt.2003.33.11.647.
- Results publication: PubMed 15179160Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.
- Results publication: PubMed 24427426Huxel Bliven KC, Anderson BE. Core stability training for injury prevention. Sports Health. 2013 Nov;5(6):514-22. doi: 10.1177/1941738113481200.
- Results publication: PubMed 32669487Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.
- Results publication: PubMed 36136067Flowers DW, Brewer W, Mitchell K, Ellison J, Frilot C. The Effect of Core Stabilization Training on Improving Gait and Self-Perceived Function in Patients with Knee Osteoarthritis: A Single-Arm Clinical Trial. Pathophysiology. 2022 Sep 1;29(3):495-506. doi: 10.3390/pathophysiology29030040.
- Results publicationMcCallister E, Flowers D. Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. Internet Journal of Allied Health Sciences and Practice. Published online 2020. doi:https://doi.org/10.46743/1540-580x/2020.1931
- Individual participant dataSharing planned: No
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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.
Daniel W. Flowers, PT, DPT, PhD principal investigator
LSU Health Sciences Center at Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip activation home exercise program and Hip activation plus core stabilization home exercise program in people with Movement, Abnormal and Lower Extremity Problem, run by Louisiana State University Health Sciences Center Shreveport 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 Apr 2024. 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?
Forward Step Down Test (FSDT) (time frame: Pre- and post-eight week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06260306, which also lists 25 linked publications.
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 Apr 2024.