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Protonics Knee Brace Versus Hamstring Resisted Exercise (HRE) on Individuals With Patellofemoral Pain Syndrome (HRE)

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ClinicalTrials.gov Identifier: NCT03042559
Recruitment Status : Unknown
Verified April 2017 by Everett Lohman, Loma Linda University.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Everett Lohman, Loma Linda University

Brief Summary:
To compare the effect of Protonics knee brace and Hamstring Resisted Exercise (HRE) on anterior pelvic tilt, hip internal rotation and adduction, and knee pain in subjects with Patellofemoral pain symptoms (PFPS) and examine the reliability and validity of self-report patellofemoral disability index (PDI) as a measure of functional performance in subjects with PFPS.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Device: Protonics Knee brace Device: Sports Cords Not Applicable

Detailed Description:

The purpose of this graduate student research study is to compare the effect of Protonics knee brace and Hamstring Resisted Exercise (HRE) on anterior pelvic tilt, hip internal rotation and adduction, and knee pain in subjects with Patellofemoral pain symptoms (PFPS) and examine the reliability and validity of self-report patellofemoral disability index (PDI) as a measure of functional performance in subjects with PFPS.

There will be three visits over 4 weeks for 1 hour per visit, but the first visit will take about 2 hours. In visit one, participants will be asked to sign an informed consent, complete five questionnaires. Then, your hip range of motion (ROM), pelvic tilt angle, and lateral step-up test will be measured. Participants will be randomly assigned to one of two groups: group one receiving the Protonics knee brace exercise, and a home program or group two getting the hamstring-resisted exercise using sport cord and home program. Participant in both groups will walk a specific distance in each phase. Phase I (walk 5 min in straight surface), Phase II (walk 8 min in inclined surface), and Phase III (walk 10 min in different direction).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Protonics Knee Brace Versus Hamstring Resisted Exercise on Individuals With Patellofemoral Pain Syndrome
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Protonics knee brace
All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion.
Device: Protonics Knee brace

Protonics Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the Protonics neuromuscular repositioning technique, Protonics gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.

In phase one, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.

In phase two, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.

In phase three, the subjects will perform Protonics Neuromuscular repositioning Techniques, Protonics gait through walking for up to 10 minutes or as tolerated, and preform one specific exercise in standing position.


Experimental: Sport cords
Resistive sports cord to resist knee flexion.
Device: Sports Cords

Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.

In phase one, the subjects will perform the sports cord gait through walking for up to 5 minutes or as tolerated, and preform warming up exercise.

In phase two, the subjects will perform the sports cord gait through walking for up to 8 minutes or as tolerated, and preform three specific exercises in prone, supine and sitting position.

In phase three, the subjects will perform the sports cord gait through walking for up to 10 minutes or as tolerated, and preform one specific exercise in standing position.





Primary Outcome Measures :
  1. Anterior Pelvic Tilt [ Time Frame: Baseline ]
    measured while subjects are in a standing position between the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS), to find the oblique angle of the pelvic


Secondary Outcome Measures :
  1. Hip internal, external rotation and adduction active ROM [ Time Frame: Baseline ]
    Subjects will be positioned in supine position to examine the hip ROM

  2. Hip internal, external rotation and adduction active ROM [ Time Frame: 15 minutes after intervention ]
    Subjects will be positioned in supine position to examine the hip ROM

  3. Hip internal, external rotation and adduction active ROM [ Time Frame: 2 weeks ]
    Subjects will be positioned in supine position to examine the hip ROM

  4. Hip internal, external rotation and adduction active ROM [ Time Frame: 4 weeks ]
    Subjects will be positioned in supine position to examine the hip ROM

  5. Lateral Step Test [ Time Frame: Baseline ]
    Subjects will be asked to report a verbal pain score during the step-up test at each test session

  6. Lateral Step Test [ Time Frame: 15 minutes after intervention ]
    Subjects will be asked to report a verbal pain score during the step-up test at each test session

  7. Lateral Step Test [ Time Frame: 2 weeks ]
    Subjects will be asked to report a verbal pain score during the step-up test at each test session

  8. Lateral Step Test [ Time Frame: 4 weeks ]
    Subjects will be asked to report a verbal pain score during the step-up test at each test session

  9. Anterior Pelvic Tilt [ Time Frame: 15 minutes after intervention ]
    measured while subjects are in a standing position between the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS), to find the oblique angle of the pelvic

  10. Anterior Pelvic Tilt [ Time Frame: 2 weeks ]
    measured while subjects are in a standing position between the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS), to find the oblique angle of the pelvic

  11. Anterior Pelvic Tilt [ Time Frame: 4 weeks ]
    measured while subjects are in a standing position between the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS), to find the oblique angle of the pelvic



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will be males and females who have Patellofemoral pain symptoms for more than 1 month, have pain level ≥ 3 on a Numeric Pain Rating Scale, and pain during at least 2 activities, such as squatting, ascending/descending stairs, and/or running.

Exclusion Criteria:

  • Subjects will be excluded if they have previous traumatic injuries to the knee joint/lower limbs, sign, and symptoms of meniscus tear or ligamentous-related pathology, neurological disorders and being on pain medication."

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042559


Contacts
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Contact: Everett Lohman, Dsc 9095584632 elohman@llu.edu
Contact: Mastour Alshaharani, MPT 2165274585

Locations
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United States, California
Loma Linda University Health Recruiting
Loma Linda, California, United States, 92354
Contact: Everett Lohman, DSC    909-558-3171 ext 83171    elohman@llu.edu   
Contact: Mastour Alshaharani, MPT    216 527 4585    malshaharani@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Everett Lohman, Dsc Loma Linda University

Publications of Results:
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Responsible Party: Everett Lohman, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03042559     History of Changes
Other Study ID Numbers: 5160417
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases