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

Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain: a Prospective Randomized Comparative Trial.

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Other: PDF Exercise Sheets; Other: Limited Exercise Videos; Other: Algorithm based Exercise Videos

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19147
      • Simpletherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 3 and 6 week survey data evaluating efficacy of the algorithm	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant compliance	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.	6 months
Safety	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.	6 months

Collaborators and Investigators

• Sponsor: Simpletherapy
• Investigators: Principal Investigator: Jonathan P Garino, MD, Simpletherapy

Publications and helpful links

General Publications

• Baker KR, Nelson ME, Felson DT, Layne JE, Sarno R, Roubenoff R. The efficacy of home based progressive strength training in older adults with knee osteoarthritis: a randomized controlled trial. J Rheumatol. 2001 Jul;28(7):1655-65.
• Margolis SA, Paule RC, Ziegler RG. Ascorbic and dehydroascorbic acids measured in plasma preserved with dithiothreitol or metaphosphoric acid. Clin Chem. 1990 Oct;36(10):1750-5.
• Bassett SF, Prapavessis H. Home-based physical therapy intervention with adherence-enhancing strategies versus clinic-based management for patients with ankle sprains. Phys Ther. 2007 Sep;87(9):1132-43. doi: 10.2522/ptj.20060260. Epub 2007 Jul 3.
• Crossley K, Bennell K, Green S, Cowan S, McConnell J. Physical therapy for patellofemoral pain: a randomized, double-blinded, placebo-controlled trial. Am J Sports Med. 2002 Nov-Dec;30(6):857-65. doi: 10.1177/03635465020300061701.
• Kim TWB, Gay N, Khemka A, Garino J. Internet-Based Exercise Therapy Using Algorithms for Conservative Treatment of Anterior Knee Pain: A Pragmatic Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2016 Dec 14;3(2):e12. doi: 10.2196/rehab.5148.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 15, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 15, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Knee pain; Patellofemoral; Anterior knee pain; Patellofemoral syndrome; Runners knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: 413