Patient Self Monitoring of Physical Therapy Exercise

This study is not yet open for participant recruitment.
Verified January 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Florence Sheehan, University of Washington
ClinicalTrials.gov Identifier:
NCT01781325
First received: October 12, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Patellofemoral Syndrome
Device: IBEHR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Patient Self Monitoring to Transfer Physical Therapy Exercise From Clinic to Home

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • adherence to physical therapy exercise [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]
    frequency (sessions, repetitions) and correctness of exercise


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IBEHR
IBEHR
Device: IBEHR
physical therapy device to educate patients in physical therapy exercise performance
No Intervention: Standard therapy
written instructions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781325

Contacts
Contact: Florence Sheehan, MD 206 543-4535 sheehan@uw.edu

Locations
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195-6422
Contact: John O'Kane, MD    206-543-6595    jokane@u.washington.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Florence Sheehan, MD University of Washington
  More Information

No publications provided

Responsible Party: Florence Sheehan, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01781325     History of Changes
Other Study ID Numbers: IBEHR, R21 HS021733
Study First Received: October 12, 2012
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
musculoskeletal, physical therapy

Additional relevant MeSH terms:
Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014