Movement, AbnormalNCT05642065
Hip Activation and FSDT
A study testing Hip muscle activation 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 study is to determine if activation training of the hip musculature affects muscle activation and frontal plane mechanics in healthy individuals. Specific Aim 1: Determine whether performance on the forward step-down test (FSDT) changes after an eight-week home exercise program (HEP) focused on hip… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Movement, Abnormal, Lower Extremity Problem
- What is being tested?
- Hip muscle activation home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 28 Apr 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be current first or second year Doctor of Physical Therapy students in the School of Allied Health Professions at LSU Health Shreveport.
Who cannot join
- Current knee pain or pathology in the dominant leg, and women with known pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130
About this study
Official title: Does a Hip Muscle Activation Home Exercise Program Change Patient Performance on the Forward Step-Down Test? A Single-Arm Clinical Trail
The purpose of this study is to determine if activation training of the hip musculature affects muscle activation and frontal plane mechanics in healthy individuals.
Specific Aim 1: Determine whether performance on the forward step-down test (FSDT) changes after an eight-week home exercise program (HEP) focused on hip musculature activation in healthy individuals.
Read more
Specific Aim 2: Determine whether surface electromyography (sEMG) hip musculature changes following an eight-week HEP focused on hip musculature activation in healthy individuals.
Specific Aim 3: Determine whether a dose-response relationship exists between compliance on the HEP and changes in FSDT scores in healthy individuals.
Specific Aim 4: Determine whether a dose-response relationship exists between compliance on the HEP and sEMG changes in hip musculature activation in healthy individuals.
- Conditions
- Movement, Abnormal, Lower Extremity Problem
- Being tested
- Hip muscle activation 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 muscle activation home exercise programOther
Participants will perform a home exercise program consisting of five hip muscle activation exercises with the use of a resistance band. The program will be eight weeks in duration, and participants will perform the exercises twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will undergo lower extremity movement assessment on the Forward Step Down Test before and after a home exercise program (HEP) consisting of five hip activation exercises. These exercises will be performed 2x/week for 8 weeks. Surface EMG of the gluteus maximus and medius, in addition to tracking of participant compliance on the HEP program will also be assessed pre- and post-intervention. Receives: Other: Hip muscle activation home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the Forward Step Down Test
Participants will perform the Forward Step Down Test pre- and post-intervention, while being score by two investigators simultaneously.
Measured: Pre- and Post- Intervention Program (8 weeks)
Secondary outcomes (3)
Surface electromyography (sEMG) - Gluteus Maximus
sEMG data for the gluteus maximus, including both mean EMG activation and peak EMG activation will be recorded during performance of the Forward Step Down Test.
Measured: Pre- and Post- Intervention Program (8 weeks)
Surface electromyography (sEMG) - Gluteus Medius
sEMG data for the gluteus medius, including both mean EMG activation and peak EMG activation will be recorded during performance of the Forward Step Down Test.
Measured: Pre- and Post- Intervention Program (8 weeks)
Home Exercise Program (HEP) Compliance
Participants will complete a log of the number of HEP sessions they complete during the 8-week intervention program. The sum of sessions completed will be used as a measure of compliance.
Measured: Pre- and Post- Intervention Program (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start26 Jan 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel W. Flowers, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Daniel W. Flowers, DPT, PhD, Principal investigator, Louisiana State University Health Sciences Center Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642065
- Sponsor's protocol ID
- STUDY00002264
- Status last verified
- Apr 2023
- First submitted
- 28 Nov 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Hip Muscle Activation Home Exercise Program Change Patient Performance on the Forward Step-Down Test? A Single-Arm Clinical Trail
- ClinicalTrials.gov ID
- NCT05642065
- Acronym / sponsor ID
- STUDY00002264
- Conditions
- Movement, Abnormal, Lower Extremity Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 8 Dec 2022 (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 study is to determine if activation training of the hip musculature affects muscle activation and frontal plane mechanics in healthy individuals.
Specific Aim 1: Determine whether performance on the forward step-down test (FSDT) changes after an eight-week home exercise program (HEP) focused on hip musculature activation in healthy individuals.
Specific Aim 2: Determine whether surface electromyography (sEMG) hip musculature changes following an eight-week HEP focused on hip musculature activation in healthy individuals.
Specific Aim 3: Determine whether a dose-response relationship exists between compliance on the HEP and changes in FSDT scores in healthy individuals.
Specific Aim 4: Determine whether a dose-response relationship exists between compliance on the HEP and sEMG changes in hip musculature activation in healthy individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Hip muscle activation home exercise programParticipants will undergo lower extremity movement assessment on the Forward Step Down Test before and after a home exercise program (HEP) consisting of five hip activation exercises. These exercises will be performed 2x/week for 8 weeks. Surface EMG of the gluteus maximus and medius, in addition to tracking of participant compliance on the HEP program will also be assessed pre- and post-intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be current first or second year Doctor of Physical Therapy students in the School of Allied Health Professions at LSU Health Shreveport.
Key exclusion criteria (1 listed)
- Current knee pain or pathology in the dominant leg, and women with 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 muscle activation home exercise programParticipants will perform a home exercise program consisting of five hip muscle activation exercises with the use of a resistance band. The program will be eight weeks in duration, and participants will perform the exercises twice weekly. | Other | Arm 1 |
Primary outcome
Scores on the Forward Step Down Test
Time frame: Pre- and Post- Intervention Program (8 weeks)
Participants will perform the Forward Step Down Test pre- and post-intervention, while being score by two investigators simultaneously.
3 secondary outcomes
Surface electromyography (sEMG) - Gluteus Maximus
Time frame: Pre- and Post- Intervention Program (8 weeks)
Surface electromyography (sEMG) - Gluteus Medius
Time frame: Pre- and Post- Intervention Program (8 weeks)
Home Exercise Program (HEP) Compliance
Time frame: Pre- and Post- Intervention Program (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 1 May 2023.
- Individual participant dataSharing planned: No
Related trials for Movement, Abnormal
RecruitingPhase 2
A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy
PARKINSON DISEASE (Disorder)
Active, not recruitingPhase 2
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
Agitation
RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
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, DPT, PhD principal investigator
Louisiana State University Health Sciences Center 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 muscle activation 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 1 May 2023. 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?
Scores on the Forward Step Down Test (time frame: Pre- and Post- Intervention Program (8 weeks)). 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 1 May 2023.