- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762212
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
34
Phase
- 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
-
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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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.
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Baseline
|
Degrees of change in hip flexion range of motion will be measured using a goniometer immediately after intervention.
Time Frame: Immediately post-intervention.
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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.
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Immediately post-intervention.
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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.
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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.
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Baseline.
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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.
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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
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)
March 9, 2021
Primary Completion (ACTUAL)
November 17, 2021
Study Completion (ACTUAL)
November 17, 2021
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 18, 2021
First Posted (ACTUAL)
February 21, 2021
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID 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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