CClinicalTrials.gg
CompletedNCT03407365Updated Jan 10, 2019

Home-Based Functional Exercise Program in Patients With Patellar Femoral Syndrome Over a 10-Week Period

An interventional study of 10 Week Exercise Program and DVD Program After 10 Weeks in Patellar Femoral Syndrome, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-01-10.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to determine if a 10 week exercise rehabilitation program decreases anterior knee oain (PFPS) and improves function in patients with patellofemoral pain syndrome (PFPS). Individuals (age 18-50) with PFPS will be recruited to participate in this study to see if a 10 week exercise program focusing in core and hip strengthening, lower extremity strengthening foot intrinsic strengthening can decrease pain and increase function.

Read the detailed description

Patellofemoral pain syndrome (PFPS) is a very prevalent condition that presents in great number to patients in physician's offices and has a high recurrence rate. Physical therapy and exercise therapy to strengthen the quadriceps is often prescribed, however recurrence is common. It is hypothesized that PFPS patients have core weakness, hip strength abnormalities and neuromuscular control deficits.

02

Conditions studied

  • Patellar Femoral Syndrome

Browse trials for

03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Individuals wishing to participate in study voluntarily
  • Subjects diagnosed with patella-femoral syndrome. We will ascertain this by asking a few questions, which will not be recorded as they have not been enrolled in the study yet.
  • Capable of following and completing a 10 week home exercise program

Exclusion criteria

Exclusion Criteria:

  • Individuals with prior knee surgery, tibial plateau fractures, known diagnosis of knee injuries such as meniscus or ligaments tears.
  • Individuals unable to participate, i.e. cognitive deficits, weakness or functional deficits to upper extremities.
  • Individuals unable to tolerate exercise program
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Home Exercises

    Patients will be given a set of home exercises to perform as part of their rehabilitation home exercise program. They will be initially trained by a research team member and will be given a DVD home exercise video with instructions on how to perform the exercises.

    Behavioral: 10 Week Exercise Program

  • Active comparator
    DVD Program

    Weeks 1-10, subjects will not be prescribed exercise at home. If the DVD program shows to help participants in Group 1, the program and DVD will be provided to Group 2 participants

    Behavioral: DVD Program After 10 Weeks

Interventions

  • Behavioral10 Week Exercise Program

    Subjects will complete a 10 week exercise program using DVD with instructions provided. Participants will have to do one session of exercise on 5 different days each week for a total of 5 sessions per week, for 10 weeks.

  • BehavioralDVD Program After 10 Weeks

    If the DVD program shows to help participants in Group 1, the program and DVD will be provided to Group 2 participants

05

What researchers measure

Primary outcomes

  1. Kujala Scale for Anterior Knee Pain

    13 item knee specific self report questionnaire that documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting and sitting for prolonged periods with knees bent, as well as symptoms such as limp, inability to weight bear through affected the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. The maximum score is 100 and lower scores indicate greater pain/disability.

    Time frame: 10 Weeks

06

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
07

Registry details

Key details

Study ID
NCT03407365
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Sep 27, 2016
Primary completion
Aug 27, 2018
Completion
Aug 27, 2018
Last update
Jan 10, 2019

Study contacts

Wayne Stokes, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion