Back to resultsConventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Algorithm based Exercise Videos
PDF Exercise Sheets
Limited Exercise Videos
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Knee pain, Anterior knee pain, Patellofemoral, Patellofemoral syndrome, Runners knee
Eligibility 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
Sites / Locations
- Simpletherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
PDF exercise sheets
Limited Exercise Videos
Algorithm based Exercise Videos
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01696162
Brief Title
Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain
Official Title
Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain: a Prospective Randomized Comparative Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Simpletherapy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Knee pain, Anterior knee pain, Patellofemoral, Patellofemoral syndrome, Runners knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDF exercise sheets
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Limited Exercise Videos
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Algorithm based Exercise Videos
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Algorithm based Exercise Videos
Intervention Description
The algorithm will adjust the exercises in each session based upon the participant's feedback.
Intervention Type
Other
Intervention Name(s)
PDF Exercise Sheets
Intervention Description
A sheet of six exercises with descriptions on how to perform them properly
Intervention Type
Other
Intervention Name(s)
Limited Exercise Videos
Intervention Description
Video of 6 exercises that provide instruction on how to perform the exercises
Primary Outcome Measure Information:
Title
The 3 and 6 week survey data evaluating efficacy of the algorithm
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Participant compliance
Description
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.
Time Frame
6 months
Title
Safety
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan P Garino, MD
Organizational Affiliation
Simpletherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simpletherapy
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19147
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11469475
Citation
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.
Results Reference
background
PubMed Identifier
2208649
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.
Results Reference
background
PubMed Identifier
17609331
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. doi: 10.2522/ptj.20060260. Epub 2007 Jul 3.
Results Reference
background
PubMed Identifier
12435653
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. doi: 10.1177/03635465020300061701.
Results Reference
background
PubMed Identifier
28582256
Citation
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.
Results Reference
derived
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Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain
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