Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simpletherapy
ClinicalTrials.gov Identifier:
NCT01696162
First received: September 15, 2012
Last updated: June 15, 2014
Last verified: June 2014
  Purpose

This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program based on user input. The investigators hypothesize that exercise therapy can be delivered safely and effectively with increased participant satisfaction compared to the current standard.


Condition Intervention
Patellofemoral Pain Syndrome
Other: Algorithm based Exercise Videos
Other: PDF Exercise Sheets
Other: Limited Exercise Videos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain: a Prospective Randomized Comparative Trial.

Resource links provided by NLM:


Further study details as provided by Simpletherapy:

Primary Outcome Measures:
  • The 3 and 6 week survey data evaluating efficacy of the algorithm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Each participant will be asked at the 3, 6 and 12 week mark to fill out a survey questionnaire that evaluates their knee pain to determine if their knee pain has improved.


Secondary Outcome Measures:
  • Participant compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will ask the participant at the 3, 6 and 12 week mark questions concerning whether they enjoyed the video exercises and whether they would do them again.

  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The screening questionnaires will be evaluated for their safety and efficacy. This will be evaluated by having followup at the 3, 6 and 12 week marks and asking if the participant had any adverse event either via phone calls or survey questionnaire.


Enrollment: 85
Study Start Date: September 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PDF exercise sheets
Participants in this arm will receive a PDF sheet of 6 exercises that are commonly administered for the treatment of anterior knee pain. They will be asked to perform the exercises three times a week for 6 weeks. A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.
Other: PDF Exercise Sheets
A sheet of six exercises with descriptions on how to perform them properly
Active Comparator: Limited Exercise Videos

Participants in this arm will receive the same six exercises as provided in the PDF sheet in arm 1 in a video format. They will be asked to perform the exercises three times per week for 6 weeks.

A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.

Other: Limited Exercise Videos
Video of 6 exercises that provide instruction on how to perform the exercises
Experimental: Algorithm based Exercise Videos
Participants in this arm will be provided a 6 week regimen of exercise videos for their anterior knee pain. Following each exercise session, the participant will be asked for their input concerning each exercise. The algorithm will adjust the exercise regimen for the next session based on the participants input. A questionnaire will be administered at the three, six and twelve week mark to evaluate efficacy, compliance and safety.
Other: Algorithm based Exercise Videos
The algorithm will adjust the exercises in each session based upon the participant's feedback.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-64 with anterior knee pain
  • Have computer access
  • Cleared for exercise by a medical professional, if not possible or a medical professional on the study team over the phone and the PAR-Q (Physical Activity Readiness Questionnaire)
  • Have consented to participate in the trial

Exclusion Criteria:

  • Age < 18 or > 64
  • Screened as unsafe for exercise by a medical professional or the, study team and/ or Screened out by the PAR-Q
  • Does not consent to the trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696162

Locations
United States, Pennsylvania
Simpletherapy
Philadelphia, Pennsylvania, United States, 19147
Sponsors and Collaborators
Simpletherapy
Investigators
Principal Investigator: Jonathan P Garino, MD Simpletherapy
  More Information

Additional Information:
Publications:
Responsible Party: Simpletherapy
ClinicalTrials.gov Identifier: NCT01696162     History of Changes
Other Study ID Numbers: 413
Study First Received: September 15, 2012
Last Updated: June 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Simpletherapy:
Knee pain
Anterior knee pain
Patellofemoral
Patellofemoral syndrome
Runners knee

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

ClinicalTrials.gov processed this record on November 25, 2014