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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696162
• Other study ID #: 413
• Status: Completed
• Phase: N/A
• First received: September 15, 2012
• Last updated: June 15, 2014
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: Simpletherapy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome

Intervention

Other:
• Algorithm based Exercise Videos
The algorithm will adjust the exercises in each session based upon the participant's feedback.
• PDF Exercise Sheets
A sheet of six exercises with descriptions on how to perform them properly
• Limited Exercise Videos
Video of 6 exercises that provide instruction on how to perform the exercises

Locations

Country	Name	City	State
United States	Simpletherapy	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Simpletherapy

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. Epub 2007 Jul 3. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes