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The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A RCT

The Impact of a mHealth Application on Outpatient Physical Therapy HEP Adherence and Outcomes: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03035682
Enrollment
104
Registered
2017-01-30
Start date
2017-01-23
Completion date
2019-12-12
Last updated
2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Disorder, Musculoskeletal Injury

Brief summary

The purpose of this study is to determine the impact a mobile health application has on adherence to a physical therapy home exercise program and its effect on functional outcomes.

Detailed description

Outpatient physical therapy is an integral aspect in combating the impairment and dysfunction associated with musculoskeletal injuries. Healthcare and insurance restrictions are leading to reduced clinic visits, encouraging efficient and effective treatments and focusing a greater demand on education, proactive wellness and home exercise maintenance. Home exercise prescription has long been a fundamental aspect to a physical therapy routine or regimen. It is well established that exercise protocols can positively impact pain, fitness levels, physical function and measures of life quality (Forkan, Pumper, Smyth, Wirkkala, A Ciol, & Shumway-Cook, 2006). It is also recognized that treatment outcomes may be negatively impacted by non-adherence to the prescribed exercise recommendation in rehabilitation (Holden, Haywood, Portia, Gee, & Mclean, 2014). Research historically suggests that levels of non-adherence to exercise prescription range from 50-70% (Bassett, 2003; Sluijs, Kok, & van der Zee, 1993), and likely increase as time passes. Investigating non-adherence demonstrates a myriad of influencing factors. These factors can be characterized as motivators and barriers. With the explosion of mobile communications access and increasing number of active device users, healthcare is embarking on the concept of mobile health management. Mobile health interventions have been found to have a positive impact in the arenas of medication compliance, weight loss, chronic disease management and postoperative complication (Lee, 2016; Ronghua, Li, (2015).The implementation of a mobile health application in physical therapy outpatient management has not been well established. It is time to investigate the impact of using a mobile health application on a prescribed physical therapy treatment regimen for the enhancement of HEP adherence and functional outcome assessment.

Interventions

OTHERAugmented Media Group

The intervention group will receive traditional PT services deemed clinically appropriate via examination plus home exercise prescription augmented via a mobile health application. The augmented media group will receive digital exercise prescription via a mobile health application source (Physitrack) that includes: high definition video and pictures, education material and written instruction, reminder notification and in-app logging of completion.

The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.

Sponsors

Aultman Health Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Any musculoskeletal pathology: spine, UE, LE 2. Age18 or older 3. Primary language is English. Ability to read, write and understand the English language 4. Ownership of mobile smart phone 5. Functional and cognitive ability to operate/manipulate a mobile media application 6. Willingness to use their data package for support/use of mobile application

Exclusion criteria

Following the initial screening criteria, the study population will be scrutinized for exclusion.

Design outcomes

Primary

MeasureTime frame
Adherence Exercise Logs: Adherence = exercise reps completed (x) sets completed (x) times per day completed (x) days per week completed divided by total number of (reps) (sets) (time per day) (days per week) assigned to the HEP regimen for each patientWeekly during course of patient standard treatment. Logs will be assessed over each 7 day period after initial treatment session and collected up to a period of 24 weeks or discharge from therapy intervention for any reason, which ever may occur first.

Secondary

MeasureTime frame
Self -report Adherence Question: Both groups will complete a single question assessment regarding their perceived level of adherence to the prescribed home exercise plan.Completed at 1 week after inital exam , at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and 3 month follow-up. 6month follow-up if subject agreeable.
Numeric Pain Rating Scale (NPRS) 0-10 scale.Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
Patient-Specific Functional Scale (PSFS)Outcome will be completed at initial exam, at discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first.
The Global Rating of Change Scale (GROC)At patient discharge from PT as defined by a period up to 24 weeks or discontinuation of therapy intervention for any reason, which ever may occur first, and at 3 month follow-up. 6month follow-up if subject agreeable.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026