Patient Self Monitoring of Physical Therapy Exercise

December 8, 2014 updated by: Florence Sheehan, University of Washington

Patient Self Monitoring to Transfer Physical Therapy Exercise From Clinic to Home

Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to show patients how to reproduce at home the exercises prescribed by their physical therapist (PT) in clinic. The IBEHR can also record home exercise sessions for review by and feedback from the PT. The HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer of physical therapy exercise from clinic to home, increased adherence to the exercise prescription, and recording home exercise to assist PT decision making.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

Our objective is to develop an IBEHR (Image-Based Electronic Health Record) to help patients to transfer and reproduce at home the exercises they were prescribed by their physical therapist (PT) in clinic. More than 17 million (M) patients are diagnosed with conditions that may benefit from PT in the U.S. each year. Adherence to home exercise is the most important factor in functional recovery, and feedback from the exercise prescriber is the most important factor in achieving patient adherence. However in current practice the patient only gets feedback at clinic visits which may be weeks apart.

The proposed IBEHR will give patients visual feedback in real time comparing their performance at each repetition at home with a recording of themselves performing the exercise correctly in the clinic under the PT's supervision. The visual graphics show the patient how to better position his/her body and extremities. Such feedback is likely to improve adherence with the treatment regimen in terms of frequency, duration, and correctness of exercise, and thus facilitates transition of care between clinic and home.

The IBEHR is also a telemedicine tool because the patient can transmit recordings of home exercise to the PT for rapid review and feedback.

A third benefit of the IBEHR is to improve health care decision making by the PT. In current medical practice, it is difficult for a PT to determine why a patient fails to recover as expected. By recording the exercise performed at home, the IBEHR provides monitoring data that informs the PT whether the patient adhered poorly to prescribed exercise frequency or duration, the patient performed the exercise incorrectly, or the PT prescribed the wrong exercise.

Our Specific Aims are to 1) develop the IBEHR software, 2) perform alpha testing of device accuracy and beta testing of user interface ease of use, and 3) perform preliminary evaluation of the efficacy of the IBEHR to improve adherence.

The HEALTH CARE BENEFITS of the IBEHR for patient self monitoring are: improved transfer of physical therapy exercise from clinic to home, increased adherence to the exercise prescription, and recording home exercise to assist PT decision making.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98195-6422
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • anterior knee pain or anterior cruciate ligament (ACL) injury, including non-operative and post-surgical patients

Exclusion Criteria:

  • non computer literate
  • nonambulatory
  • non English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IBEHR
physical therapy device to educate patients in physical therapy exercise performance
No Intervention: Standard therapy
written instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence to physical therapy exercise
Time Frame: 4 to 8 weeks
frequency (sessions, repetitions) and correctness of exercise
4 to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Florence Sheehan, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • IBEHR
  • R21HS021733 (U.S. AHRQ Grant/Contract)

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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