Examining the Effects of a Mobilization With Movement and a Dynamic Stretch With Over Pressure on Hip Flexion.

November 30, 2021 updated by: Cathy Arnot, University of South Carolina

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The sole inclusion criterion will be a limitation in hip flexion to less than 101 degrees in both hips.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Hip with the greatest limitation in flexion range of motion
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.
Procedure: Mobilization with movement and stretching, stretching or control
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.
ACTIVE_COMPARATOR: Hip with the least limitation in flexion range of motion
Participants least limited hip in flexion range of motion will serve as the control group. This limb will not receive an intervention.
Procedure: Mobilization with movement and stretching, stretching or control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Immediately post-intervention.
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.
24 hours after intervention.
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.
1 week after intervention.
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.
Baseline.
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.
Immediately post-intervention.
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.
24 hours after intervention.
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.
1 week after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00103113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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