Control of Frontal Plane BiomechanicsNCT06298903

Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test

A study testing Hip Activation and Hip activation + Single leg balance in people with Control of Frontal Plane Biomechanics and Patellofemoral Pain Syndrome, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Control of Frontal Plane Biomechanics, Patellofemoral Pain Syndrome
What is being tested?: Hip Activation and Hip activation + Single leg balance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 12 Jan 2024to 1 Aug 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 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

first or second year students at the institutions's School of Allied Health Professions
healthy
female

Who cannot join

participating in another research study
current knee pain or pathology on the dominant leg
known diagnosis of vestibular impairment
known pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

LSUHSC-Shreveport
Shreveport, Louisiana, 71103

Other trials in United States

About this study

Official title: The Effect of a Hip Activation Home Exercise Program (HEP) Compared to a Hip Activation + Single Leg Balance HEP on the Forward Step-Down Test in Healthy Females

The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements.

Conditions: Control of Frontal Plane Biomechanics, Patellofemoral Pain Syndrome
Being tested: Hip Activation, Hip activation + Single leg balance
Medical subject headings: Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hip ActivationOther
Sidelying hip abduction, side plank with hip abduction, clamshell (hip abduction + external rotation), side plan with clamshell, and quadruped fire hydrant exercises will be performed for 1 minute isometric holds, 2 times per week for 8 weeks.
Hip activation + Single leg balanceOther
Hip activation HEP: Sidelying hip abduction, side plank with hip abduction, clamshell (hip abduction + external rotation), side plan with clamshell, and quadruped fire hydrant exercises will be performed for 1 minute isometric holds, 2 times per week for 8 weeks.
Single leg balance: variety of single leg balance exercises with different upper extremity and lower extremity positions to provide different balance stimuli. Weeks are alternated performing these exercises with eyes open and eyes closed.

Study groups in NCT06298903
Study group	Role	What they receive
Hip activation	Active comparator	Participants will perform a hip muscle activation program 2 days per week for 8 weeks. The HEP consists of 5 exercises that target the gluteal muscles. Receives: Other: Hip Activation
Hip activation + Single leg balance	Experimental	Participants will perform a hip muscle activation program as in the active comparator group, plus a single leg balance training HEP 2 days per week for 8 weeks. The hip HEP consists of 5 exercises that target the gluteal muscles. The single leg balance HEP consists of a variety of eyes open and eyes closed single leg balance exercises. Receives: Other: Hip activation + Single leg balance

What is being measured

The primary outcome is the main question the study is designed to answer.

Forward-Step-Down Test
a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.
Measured: pre-intervention (baseline), post-intervention (8 weeks)

Secondary outcomes (4)

surface electromyography (sEMG) peak
The peak sEMG will be collected from the dominant side's gluteus maximum and gluteus medius muscles. The sEMG will be collected during both the FSDT and unipedal stance test
Measured: pre-intervention (baseline), post-intervention (8 weeks)
surface electromyography (sEMG) mean
The mean sEMG will be collected from the dominant side's gluteus maximum and gluteus medius muscles. The sEMG will be collected during both the FSDT and unipedal stance test
Measured: pre-intervention (baseline), post-intervention (8 weeks)
Unipedal Stance Test (UPST)
The time a participant can stand on one leg will be collected for eyes open and eyes closed conditions.
Measured: pre-intervention (baseline), post-intervention (8 weeks)
Dose-Response
The dose-response for outcome 1, 2, and 3 will be calculated, using participant's self-reported exercise compliance as the dose.
Measured: post-intervention (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 20241 Aug 2024

First posted7 Mar 2024
Study start12 Jan 2024
Primary completion25 Mar 2024
Study completion1 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Control of Frontal Plane BiomechanicsStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06298903
Sponsor's protocol ID: STUDY00002565
Status last verified: Dec 2024
First submitted: 19 Jan 2024
Last updated: 13 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cannon 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 35189569
Rinaldi VG, Prill R, Jahnke S, Zaffagnini S, Becker R. The influence of gluteal muscle strength deficits on dynamic knee valgus: a scoping review. J Exp Orthop. 2022 Aug 17;9(1):81. doi: 10.1186/s40634-022-00513-8.
PubMed 35976534
Wilczynski B, Zorena K, Slezak D. Dynamic Knee Valgus in Single-Leg Movement Tasks. Potentially Modifiable Factors and Exercise Training Options. A Literature Review. Int J Environ Res Public Health. 2020 Nov 6;17(21):8208. doi: 10.3390/ijerph17218208.
PubMed 33172101
Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
PubMed 22027216
Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014 May;95(5):900-7. doi: 10.1016/j.apmr.2013.12.022. Epub 2014 Jan 16.
PubMed 24440362
Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.
PubMed 25879452
Hewett TE, Myer GD, Ford KR. Decrease in neuromuscular control about the knee with maturation in female athletes. J Bone Joint Surg Am. 2004 Aug;86(8):1601-8. doi: 10.2106/00004623-200408000-00001.
PubMed 15292405
Lee SP, Powers CM. Individuals with diminished hip abductor muscle strength exhibit altered ankle biomechanics and neuromuscular activation during unipedal balance tasks. Gait Posture. 2014 Mar;39(3):933-8. doi: 10.1016/j.gaitpost.2013.12.004. Epub 2013 Dec 12.
PubMed 24373699
Hatton AL, Kemp JL, Brauer SG, Clark RA, Crossley KM. Impairment of dynamic single-leg balance performance in individuals with hip chondropathy. Arthritis Care Res (Hoboken). 2014 May;66(5):709-16. doi: 10.1002/acr.22193.
PubMed 24115764
Alfuth M, Gomoll M. Electromyographic analysis of balance exercises in single-leg stance using different instability modalities of the forefoot and rearfoot. Phys Ther Sport. 2018 May;31:75-82. doi: 10.1016/j.ptsp.2018.01.002. Epub 2018 Mar 21.
PubMed 29573984
Anguish B, Sandrey MA. Two 4-Week Balance-Training Programs for Chronic Ankle Instability. J Athl Train. 2018 Jul;53(7):662-671. doi: 10.4085/1062-6050-555-16.
PubMed 30192681
Rothermel S, Hale S, Hertel J, Denegar C. Effect of active foot positioning on the outcome of a balance training program. Physical Therapy in Sport. 2004. 5:2 (98-103). https://doi.org/10.1016/j.ptsp.2004.02.002.
McCallister E, Flowers DW. Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. The Internet Journal of Allied Health Sciences and Practice. 2020 Jan 01;18(4), Article 7. doi: 10.46743/1540-580X/2020.1931
Hopper AJ, Haff EE, Joyce C, Lloyd RS, Haff GG. Neuromuscular Training Improves Lower Extremity Biomechanics Associated with Knee Injury during Landing in 11-13 Year Old Female Netball Athletes: A Randomized Control Study. Front Physiol. 2017 Nov 7;8:883. doi: 10.3389/fphys.2017.00883. eCollection 2017.
PubMed 29163219
McGovern RP, Martin RL, Christoforetti JJ, Kivlan BR. EVIDENCE-BASED PROCEDURES FOR PERFORMING THE SINGLE LEG SQUAT AND STEP-DOWN TESTS IN EVALUATION OF NON-ARTHRITIC HIP PAIN: A LITERATURE REVIEW. Int J Sports Phys Ther. 2018 Jun;13(3):526-536.
PubMed 30038839

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of a Hip Activation Home Exercise Program (HEP) Compared to a Hip Activation + Single Leg Balance HEP on the Forward Step-Down Test in Healthy Females
ClinicalTrials.gov ID: NCT06298903
Acronym / sponsor ID: STUDY00002565
Conditions: Control of Frontal Plane Biomechanics, Patellofemoral Pain Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
Study start: 12 Jan 2024 (actual)
Primary completion: 25 Mar 2024 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 7 Mar 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Hip activation	Active comparator	Other: Hip ActivationParticipants will perform a hip muscle activation program 2 days per week for 8 weeks. The HEP consists of 5 exercises that target the gluteal muscles.
Hip activation + Single leg balance	Experimental	Other: Hip activation + Single leg balanceParticipants will perform a hip muscle activation program as in the active comparator group, plus a single leg balance training HEP 2 days per week for 8 weeks. The hip HEP consists of 5 exercises that target the gluteal muscles. The single leg balance HEP consists of a variety of eyes open and eyes closed single leg balance exercises.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

first or second year students at the institutions's School of Allied Health Professions
healthy
female

Key exclusion criteria (4 listed)

participating in another research study
current knee pain or pathology on the dominant leg
known diagnosis of vestibular impairment
known pregnancy

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 ActivationSidelying hip abduction, side plank with hip abduction, clamshell (hip abduction + external rotation), side plan with clamshell, and quadruped fire hydrant exercises will be performed for 1 minute isometric holds, 2 times per week for 8 weeks.	Other	Hip activation
Hip activation + Single leg balanceHip activation HEP: Sidelying hip abduction, side plank with hip abduction, clamshell (hip abduction + external rotation), side plan with clamshell, and quadruped fire hydrant exercises will be performed for 1 minute isometric holds, 2 times per week for 8 weeks. Single leg balance: variety of single leg balance exercises with different upper extremity and lower extremity positions to provide different balance stimuli. Weeks are alternated performing these exercises with eyes open and eyes closed.	Other	Hip activation + Single leg balance

Primary outcome

Forward-Step-Down Test
Time frame: pre-intervention (baseline), post-intervention (8 weeks)
a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.

4 secondary outcomes

surface electromyography (sEMG) peak
Time frame: pre-intervention (baseline), post-intervention (8 weeks)
surface electromyography (sEMG) mean
Time frame: pre-intervention (baseline), post-intervention (8 weeks)
Unipedal Stance Test (UPST)
Time frame: pre-intervention (baseline), post-intervention (8 weeks)
Dose-Response
Time frame: post-intervention (8 weeks)

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 13 Dec 2024.
Background: PubMed 35189569Cannon 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.
Background: PubMed 35976534Rinaldi VG, Prill R, Jahnke S, Zaffagnini S, Becker R. The influence of gluteal muscle strength deficits on dynamic knee valgus: a scoping review. J Exp Orthop. 2022 Aug 17;9(1):81. doi: 10.1186/s40634-022-00513-8.
Background: PubMed 33172101Wilczynski B, Zorena K, Slezak D. Dynamic Knee Valgus in Single-Leg Movement Tasks. Potentially Modifiable Factors and Exercise Training Options. A Literature Review. Int J Environ Res Public Health. 2020 Nov 6;17(21):8208. doi: 10.3390/ijerph17218208.
Background: PubMed 22027216Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
Background: PubMed 24440362Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014 May;95(5):900-7. doi: 10.1016/j.apmr.2013.12.022. Epub 2014 Jan 16.
Background: PubMed 25879452Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.
Background: PubMed 15292405Hewett TE, Myer GD, Ford KR. Decrease in neuromuscular control about the knee with maturation in female athletes. J Bone Joint Surg Am. 2004 Aug;86(8):1601-8. doi: 10.2106/00004623-200408000-00001.
Background: PubMed 24373699Lee SP, Powers CM. Individuals with diminished hip abductor muscle strength exhibit altered ankle biomechanics and neuromuscular activation during unipedal balance tasks. Gait Posture. 2014 Mar;39(3):933-8. doi: 10.1016/j.gaitpost.2013.12.004. Epub 2013 Dec 12.
Background: PubMed 24115764Hatton AL, Kemp JL, Brauer SG, Clark RA, Crossley KM. Impairment of dynamic single-leg balance performance in individuals with hip chondropathy. Arthritis Care Res (Hoboken). 2014 May;66(5):709-16. doi: 10.1002/acr.22193.
Background: PubMed 29573984Alfuth M, Gomoll M. Electromyographic analysis of balance exercises in single-leg stance using different instability modalities of the forefoot and rearfoot. Phys Ther Sport. 2018 May;31:75-82. doi: 10.1016/j.ptsp.2018.01.002. Epub 2018 Mar 21.
Background: PubMed 30192681Anguish B, Sandrey MA. Two 4-Week Balance-Training Programs for Chronic Ankle Instability. J Athl Train. 2018 Jul;53(7):662-671. doi: 10.4085/1062-6050-555-16.
BackgroundRothermel S, Hale S, Hertel J, Denegar C. Effect of active foot positioning on the outcome of a balance training program. Physical Therapy in Sport. 2004. 5:2 (98-103). https://doi.org/10.1016/j.ptsp.2004.02.002.
Individual participant dataSharing planned: No

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.

Erin McCallister, DPT principal investigator

LSUHSC-Shreveport

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 13 Dec 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 (time frame: pre-intervention (baseline), post-intervention (8 weeks)). 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 NCT06298903, which also lists 29 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 13 Dec 2024.