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

NCT01696162 | Completed DMC

• 1 other identifier: 413
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Knee pain; Anterior knee pain; Patellofemoral; Patellofemoral syndrome; Runners knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Participant compliance

  6 months

• Safety

  6 months

Study Arms (3)

PDF exercise sheets

ACTIVE COMPARATOR

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

Limited Exercise Videos

ACTIVE COMPARATOR

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

Algorithm based Exercise Videos

EXPERIMENTAL

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

Interventions

Algorithm based Exercise Videos OTHER

The algorithm will adjust the exercises in each session based upon the participant's feedback.

Algorithm based Exercise Videos

PDF Exercise Sheets OTHER

A sheet of six exercises with descriptions on how to perform them properly

PDF exercise sheets

Limited Exercise Videos OTHER

Video of 6 exercises that provide instruction on how to perform the exercises

Limited Exercise Videos

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simpletherapy: lead

Study Sites (1)

Simpletherapy

Philadelphia, Pennsylvania, 19147, United States

Location

Related Publications (5)

• 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.

  PMID: 11469475 BACKGROUND

• 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.

  PMID: 2208649 BACKGROUND

• 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.

  PMID: 17609331 BACKGROUND

• 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.

  PMID: 12435653 BACKGROUND

• 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.

  PMID: 28582256 DERIVED

Related Links

• Trial Enrollment Webpage

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jonathan P Garino, MD

  Simpletherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2012
• First Posted: September 28, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

US (1)