Patient Self Monitoring of Physical Therapy Exercise

Patellofemoral Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01781325
• Other study ID #: IBEHR
• Secondary ID: R21HS021733
• Status: Withdrawn
• Phase: N/A
• First received: October 12, 2012
• Last updated: December 8, 2014
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Patellofemoral Syndrome

Intervention

Device:
• IBEHR
physical therapy device to educate patients in physical therapy exercise performance

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to physical therapy exercise	frequency (sessions, repetitions) and correctness of exercise	4 to 8 weeks	No