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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03407365
Collaborator
(none)
11
1
2
23
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 10 Week Exercise Program
  • Behavioral: DVD Program After 10 Weeks
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy of A Home-Based Functional Exercise Program in Patients With Patellar Femoral Syndrome Over a 10-Week Period
Actual Study Start Date :
Sep 27, 2016
Actual Primary Completion Date :
Aug 27, 2018
Actual Study Completion Date :
Aug 27, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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.

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

Outcome Measures

Primary Outcome Measures

  1. Kujala Scale for Anterior Knee Pain [10 Weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Wayne Stokes, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03407365
Other Study ID Numbers:
  • 12-00210
First Posted:
Jan 23, 2018
Last Update Posted:
Jan 10, 2019
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2019