Hip; AnomalyNCT04762212
Examining the Effects of a Mobilization With Movement and a Dynamic Stretch With Over Pressure on Hip Flexion.
A study of Hip; Anomaly, run by University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of a mobilization with movement (MWM) technique performed by a physical therapist with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip; Anomaly
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 17 Nov 2021
- 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
- The sole inclusion criterion will be a limitation in hip flexion to less than 101 degrees in both hips.
Who cannot join
- Any traumatic injury to or surgical procedure performed upon the lower extremities within the last six months
- Any contraindication to dynamic stretching, weight-bearing rotation, or MWM of the hip joint
- Any dermatologic pathology in the area of the strap application
- Any pain provoked by active hip flexion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Examining the Effects of a Posterolateral Mobilization With Movement (MWM) and a Dynamic Stretch With Over Pressure on Hip Flexion: A Randomized Control Trial.
The purpose of this study is to compare the effects of a mobilization with movement (MWM) technique performed by a physical therapist with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations. There is limited evidence available in the literature examining the therapeutic effects of MWM at the hip, the long term effects of MWM, or whether one modality is more effective than another. This study seeks to address these gaps in the literature by directly comparing the results of these two manual therapy interventions on active hip flexion ROM.
Read the detailed description
This study aims to compare the effects of a therapist-performed mobilization with movement (MWM) technique with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations.Those individuals from the University of South Carolina's Department of Physical Therapy (UofSC DPT) community who are interested in becoming study participants will be identified by means of announcements made in the Seminar in Physical Therapy course which is attended by all students, faculty, and staff of UofSC DPT each week. Interested individuals will be provided with Cathy Arnot's email address in order to schedule an evaluation session to determine whether or not they meet the study's inclusion and exclusion criteria. In addition, Sarah Cooper will attend a staff meeting at Vertex PT Specialists to make an announcement and provide the attendees with Cathy Arnot's email for inquiries. Participants will be assigned to either the MWM group or the dynamic stretch with over pressure group via blocked randomization for sex and age, with at least seventeen participants being placed into each group. The MWM group participants will receive a therapist-performed MWM technique and a prescription for a home exercise program (HEP) consisting of a dynamic stretch with over pressure to be performed once a day over the course of the following week. The dynamic stretch with over pressure group participants will receive only the prescription for the HEP consisting of the dynamic stretch with over pressure to be performed once a day over the following week. Measurements will be assessed at four time points: Immediately before the intervention, immediately after the intervention, 24 hours after the intervention, and one week after the intervention.
- Conditions
- Hip; Anomaly
- Being tested
- Mobilization with movement and stretching, stretching or control
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with movement and stretching, stretching or controlProcedure or surgery
The participants will receive a therapist performed mobilization with movement and then instructed in a stretching program to be followed for one week or only receive instruction in a stretching program to be followed for one week on the hip with the greatest limitation in motion. The hip with the least amount of limitation will not receive an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Hip with the greatest limitation in flexion range of motion | Active comparator | Participants that have limited hip flexion of less than 101 degrees will be randomly assigned to one of two groups: one intervention group will receive Mobilization with Movement and home program of stretching with over-pressure one group will receive only a home program of stretching with over-pressure. Receives: Procedure: Mobilization with movement and stretching, stretching or control |
| Hip with the least limitation in flexion range of motion | Active comparator | Participants least limited hip in flexion range of motion will serve as the control group. This limb will not receive an intervention. Receives: Procedure: Mobilization with movement and stretching, stretching or control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of change in hip flexion range of motion will be measured using a goniometer at baseline.
Degrees of hip flexion range of motion will be measured before intervention with the participant in supine .All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Measured: Baseline
Degrees of change in hip flexion range of motion will be measured using a goniometer immediately after intervention.
Degrees of hip flexion range of motion will be measured immediately after intervention with the participant in supine .All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Measured: Immediately post-intervention.
Degrees of change in hip flexion range of motion will be measured using a goniometer 24 hours after intervention.
Degrees of hip flexion range of motion will be measured 24 hours after intervention with the participant in supine. All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Measured: 24 hours after intervention.
Degrees of change in hip flexion range of motion will be measured using a goniometer one week after intervention.
Degrees of hip flexion range of motion will be measured one week after intervention with the participant in supine. All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Measured: 1 week after intervention.
Star Excursion Balance Test (SEBT) at baseline
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Measured: Baseline.
Star Excursion Balance Test (SEBT) immediately post-intervention
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Measured: Immediately post-intervention.
Star Excursion Balance Test (SEBT) 24 hours after intervention
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Measured: 24 hours after intervention.
Star Excursion Balance Test (SEBT) one week after intervention
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Measured: 1 week after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start9 Mar 2021
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip; AnomalyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- A parallel design, also called a parallel group study, compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then results are compared.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Arnot, University of South Carolina
- Investigators
- Cathy F Arnot, DPT, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762212
- Sponsor's protocol ID
- Pro00103113
- Status last verified
- Nov 2021
- First submitted
- 9 Feb 2021
- Last updated
- 2 Dec 2021
- 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of a Posterolateral Mobilization With Movement (MWM) and a Dynamic Stretch With Over Pressure on Hip Flexion: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04762212
- Acronym / sponsor ID
- Pro00103113
- Conditions
- Hip; Anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 21 Feb 2021 (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 compare the effects of a mobilization with movement (MWM) technique performed by a physical therapist with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations. There is limited evidence available in the literature examining the therapeutic effects of MWM at the hip, the long term effects of MWM, or whether one modality is more effective than another. This study seeks to address these gaps in the literature by directly comparing the results of these two manual therapy interventions on active hip flexion ROM.
Detailed description
This study aims to compare the effects of a therapist-performed mobilization with movement (MWM) technique with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations.Those individuals from the University of South Carolina's Department of Physical Therapy (UofSC DPT) community who are interested in becoming study participants will be identified by means of announcements made in the Seminar in Physical Therapy course which is attended by all students, faculty, and staff of UofSC DPT each week. Interested individuals will be provided with Cathy Arnot's email address in order to schedule an evaluation session to determine whether or not they meet the study's inclusion and exclusion criteria. In addition, Sarah Cooper will attend a staff meeting at Vertex PT Specialists to make an announcement and provide the attendees with Cathy Arnot's email for inquiries. Participants will be assigned to either the MWM group or the dynamic stretch with over pressure group via blocked randomization for sex and age, with at least seventeen participants being placed into each group. The MWM group participants will receive a therapist-performed MWM technique and a prescription for a home exercise program (HEP) consisting of a dynamic stretch with over pressure to be performed once a day over the course of the following week. The dynamic stretch with over pressure group participants will receive only the prescription for the HEP consisting of the dynamic stretch with over pressure to be performed once a day over the following week. Measurements will be assessed at four time points: Immediately before the intervention, immediately after the intervention, 24 hours after the intervention, and one week after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel design, also called a parallel group study, compares two or more treatments. Participants are randomly assigned to either group, treatments are administered, and then results are compared.
| Arm | Type | Receives |
|---|---|---|
| Hip with the greatest limitation in flexion range of motion | Active comparator | Procedure: Mobilization with movement and stretching, stretching or controlParticipants that have limited hip flexion of less than 101 degrees will be randomly assigned to one of two groups: one intervention group will receive Mobilization with Movement and home program of stretching with over-pressure one group will receive only a home program of stretching with over-pressure. |
| Hip with the least limitation in flexion range of motion | Active comparator | Procedure: Mobilization with movement and stretching, stretching or controlParticipants least limited hip in flexion range of motion will serve as the control group. This limb will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The sole inclusion criterion will be a limitation in hip flexion to less than 101 degrees in both hips.
Key exclusion criteria (4 listed)
- Any traumatic injury to or surgical procedure performed upon the lower extremities within the last six months
- Any contraindication to dynamic stretching, weight-bearing rotation, or MWM of the hip joint
- Any dermatologic pathology in the area of the strap application
- Any pain provoked by active hip flexion.
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 |
|---|---|---|
| Mobilization with movement and stretching, stretching or controlThe participants will receive a therapist performed mobilization with movement and then instructed in a stretching program to be followed for one week or only receive instruction in a stretching program to be followed for one week on the hip with the greatest limitation in motion. The hip with the least amount of limitation will not receive an intervention. | Procedure or surgery | Hip with the greatest limitation in flexion range of motion, Hip with the least limitation in flexion range of motion |
Primary outcome
Degrees of change in hip flexion range of motion will be measured using a goniometer at baseline.
Time frame: Baseline
Degrees of hip flexion range of motion will be measured before intervention with the participant in supine .All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Degrees of change in hip flexion range of motion will be measured using a goniometer immediately after intervention.
Time frame: Immediately post-intervention.
Degrees of hip flexion range of motion will be measured immediately after intervention with the participant in supine .All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Degrees of change in hip flexion range of motion will be measured using a goniometer 24 hours after intervention.
Time frame: 24 hours after intervention.
Degrees of hip flexion range of motion will be measured 24 hours after intervention with the participant in supine. All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Degrees of change in hip flexion range of motion will be measured using a goniometer one week after intervention.
Time frame: 1 week after intervention.
Degrees of hip flexion range of motion will be measured one week after intervention with the participant in supine. All measurements will be taken using a goniometer which measures range of motion in degrees from 0-360.
Star Excursion Balance Test (SEBT) at baseline
Time frame: Baseline.
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Star Excursion Balance Test (SEBT) immediately post-intervention
Time frame: Immediately post-intervention.
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Star Excursion Balance Test (SEBT) 24 hours after intervention
Time frame: 24 hours after intervention.
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
Star Excursion Balance Test (SEBT) one week after intervention
Time frame: 1 week after intervention.
The participants will perform the posterior, posterolateral, and posteromedial portions of the SEBT. The SEBT is standardized test the participant stands in the center of a mat with "stars" in 8 directions. The particpant stands on one foot and reaches with their opposite foot as far as they can without losing balance. It is method to measure functional hip flexion.
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 2 Dec 2021.
- 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.
Cathy F Arnot, DPT principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hip; Anomaly, run by University of South Carolina 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 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 2 Dec 2021. 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?
Degrees of change in hip flexion range of motion will be measured using a goniometer at baseline. (time frame: Baseline). The study lists 8 primary outcomes in all. 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 2 Dec 2021.