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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02324829
Other study ID # ORE 18193
Secondary ID REB 12-025
Status Completed
Phase N/A
First received December 3, 2014
Last updated June 16, 2016
Start date November 2012
Est. completion date December 2015

Study information

Verified date June 2016
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

Physiotherapists spend a large amount of their time with patients observing their rehabilitation techniques. A patient going through rehabilitation exercises are routine and does not necessarily require the attention of the physiotherapist. This research will develop a sensor system that will be strapped onto the patients and will provide feedback on how accurately the exercise is being executed. This will free up the physiotherapist to focus on diagnosis and other tasks that will better utilize the physiotherapist's training. A previous study has shown that this system is feasible for healthy subjects. This study would test to see if this system is extendable to rehabilitation subjects.


Description:

Many of the tasks performed regularly by physiotherapists during any given rehabilitation session are repetitive and do not rely on the physiotherapist's expertise, and could be performed and observed by automated means. The developed system will detect patient body postures and movements with data collected through sensors such as accelerometers. This data will be pattern matched to a predetermined movement pattern and feedback will be provided for patients regarding accuracy of their exercises. This data can be logged for the physiotherapist to examine at a later time. By automating this component of a rehabilitation session, the system will allow the physiotherapist to focus diagnosis and other tasks that will better utilize their training. The specific application for this prototype will be post-operative knee/hip replacement patients, so all devices must be non-invasive and must not interfere with normal recovery processes.

A previous version of this experiment on healthy participants has been successfully performed. This study would like to examine the feasibility of this system on rehabilitation subjects, as the movement patterns of a subject in physical rehabilitation may be dramatically different then a healthy subject. No intervention is suggested by the system, as this study is observational.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2015
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Any patient who has had hip and/or knee total joint replacement and requires rehabilitation, and are assessed by physiotherapists as likely able to finish their rehabilitation cycle and be discharged to home.

- Patients with medical complications or other injuries will be not be excluded, as we are interested in seeing the movement profiles of a wide range of people.

- In-patients

Exclusion Criteria:

- Patients at risk of developing serious postoperative complications, such as an infection, myocardial infarction or anything that requires subsequent surgery, they may be excluded.

- Out-patients.

- Patients who cannot give explicit consent or understand the physiotherapist's instructions

- Patients who do not speak fluent English

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Lower-body Total Joint Replacement

Locations

Country Name City State
Canada Toronto Rehabilitation Instititue Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Waterloo Natural Sciences and Engineering Research Council, Canada, Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Feng-Shun Lin J, Kulic D. Segmenting human motion for automated rehabilitation exercise analysis. Conf Proc IEEE Eng Med Biol Soc. 2012;2012:2881-4. doi: 10.1109/EMBC.2012.6346565. — View Citation

Lin JF, Kulic D. Human pose recovery using wireless inertial measurement units. Physiol Meas. 2012 Dec;33(12):2099-115. doi: 10.1088/0967-3334/33/12/2099. Epub 2012 Nov 23. — View Citation

Lin JF, Kulic D. Online Segmentation of Human Motion for Automated Rehabilitation Exercise Analysis. IEEE Trans Neural Syst Rehabil Eng. 2014 Jan;22(1):168-80. doi: 10.1109/TNSRE.2013.2259640. Epub 2013 May 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Joint angle assessment Inertial measurement unit (IMU) data will be translated to joint angles via extended Kalman filter and kinematic modeling. 2 weeks No
Secondary Motion segmentation and identification The joint angle data will be processed to automatically segment and identify rehabilitation motion. 2 weeks No