Using a Smartphone App to Aid in Functional Mobility Return Following Total Knee Arthroplasty
Traditional Home Health Physical Therapy Versus a Smartphone App for Patients Recovering From Total Knee Arthroplasty During the Home-bound Portion of Recovery: Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Eric M Rippetoe, DPT
- Phone Number: 318-560-5726
- Email: eric@lagniappept.com
Study Locations
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71106
- Recruiting
- Office
-
Contact:
- Eric M Rippetoe, DPT
- Phone Number: 318-560-5726
- Email: Errippetoe@aol.com
-
Principal Investigator:
- Eric M Rippetoe, DPT
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participants aged 45 to 64
- unilateral TKA
- subject discharged directly to home from the hospital
Exclusion Criteria:
- subject does not engage with the app within 24 hours of discharge from the hospital
- subject neglects to engage with the app over any 24-hour period during the study
- subject is readmitted to the hospital at any point during the home bound portion of their recovery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Smartphone App Users
Smartphone App Users will receive important information and prescriptive exercise via a smartphone app upon returning home from the hospital following total knee arthroplasty
|
Smartphone App Users will engage with the app at least daily and follow along with the prescriptive exercises as instructed.
|
|
ACTIVE_COMPARATOR: Home Health Users
Home Health Users will have already undergone traditional home health physical therapy and/or skilled nursing for the purpose of comparing outcomes
|
Home Health users will have received traditional home health physical therapy and skilled nursing services.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Knee Range of Motion (ROM) change
Time Frame: Baseline and through study completion, usually 2 to 4 weeks
|
Initial knee ROM will be taken within 48 hours of discharge home from hospital.
Final knee ROM will be taken upon participant no longer being homebound and expressing readiness to begin outpatient physical therapy
|
Baseline and through study completion, usually 2 to 4 weeks
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (shortened version)
Time Frame: Baseline and through study completion, usually 2 to 4 weeks
|
Questionnaire to be completed by participant at time of initial data collection described above.
Final questionnaire also completed as described above
|
Baseline and through study completion, usually 2 to 4 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Reported App Engagement
Time Frame: Data collected at final assessment, usually 2 to 4 weeks
|
Participant will self-report frequency of app engagement
|
Data collected at final assessment, usually 2 to 4 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Eric M Rippetoe, DPT, Owner of Lagniappe Physical Therapy
Publications and helpful links
General Publications
- Whitehouse SL, Lingard EA, Katz JN, Learmonth ID. Development and testing of a reduced WOMAC function scale. J Bone Joint Surg Br. 2003 Jul;85(5):706-11.
- Abbott JH, Hobbs C, Gwynne-Jones D; MOA Trial Team. The ShortMAC: Minimum Important Change of a Reduced Version of the Western Ontario and McMaster Universities Osteoarthritis Index. J Orthop Sports Phys Ther. 2018 Feb;48(2):81-86. doi: 10.2519/jospt.2018.7676. Epub 2017 Oct 21.
- Weinstein AM, Rome BN, Reichmann WM, Collins JE, Burbine SA, Thornhill TS, Wright J, Katz JN, Losina E. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013 Mar 6;95(5):385-92. doi: 10.2106/JBJS.L.00206.
- Losina E, Thornhill TS, Rome BN, Wright J, Katz JN. The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic. J Bone Joint Surg Am. 2012 Feb 1;94(3):201-7. doi: 10.2106/JBJS.J.01958.
- Bleijenberg N, Smith AK, Lee SJ, Cenzer IS, Boscardin JW, Covinsky KE. Difficulty Managing Medications and Finances in Older Adults: A 10-year Cohort Study. J Am Geriatr Soc. 2017 Jul;65(7):1455-1461. doi: 10.1111/jgs.14819. Epub 2017 Apr 5.
Helpful Links
- Rate of All-Listed Procedures for Discharges from Short-Stay Hospitals, by Procedure Category and Age: United States, Centers for Disease Control and Prevention, 2010
- Zeng E, Waldo D. Total Knee Arthroplasty Post Acute Care Costs by Discharge Status. Value in Health. 2016.
- Mobile Fact Sheet. Pew Research Center. 2018 Feb 5.
- Louisiana Home Health State Regulations. Department of Health and Hospitals. Office of the Secretary. Bureau of Health Services Financing. Louisiana Register. Vol 27, No 12, 2001 Dec 20. Accessed online
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 4357
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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