Lower-body Total Joint ReplacementNCT02324829
Automatic Physiotherapy and Rehabilitation System for Lower Body Total Joint Replacement
An observational study of Lower-body Total Joint Replacement, run by University of Waterloo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower-body Total Joint Replacement
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Specific target audience for sensor deployment is patients who has undergone knee or hip joint replacement and is taking physiotherapy rehabilitation sessions to recover. The target audience of this system is rehabilitation subjects who have recently had knee or hip replacement therapy. We would like to track several subjects over their rehabilitation stay to see the impact of rehabilitation on their movement pattern. Recruitment will be limited to in-patients only, as out-patients tend to be discharged from rehabilitation because they are healthier, and would likely have movement patterns closer to healthy subjects.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Lower-body Total Joint Replacement
- Keywords
- Total joint replacement, Physiotherapy, Kalman filtering, Kinematic modeling, Hidden Markov model, Motion segmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total joint replacement | Patients who has undergone lower body total joint replacement surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint angle assessment
Inertial measurement unit (IMU) data will be translated to joint angles via extended Kalman filter and kinematic modeling.
Measured: 2 weeks
Secondary outcomes (1)
Motion segmentation and identification
The joint angle data will be processed to automatically segment and identify rehabilitation motion.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower-body Total Joint ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Rehabilitation Institute, Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
- Investigators
- Dana Kulic, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324829
- Sponsor's protocol ID
- ORE 18193
- Other IDs
- REB 12-025
- Status last verified
- Jun 2016
- First submitted
- 3 Dec 2014
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23174667Feng-Shun Lin J, Kulic D. Segmenting human motion for automated rehabilitation exercise analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:2881-4. doi: 10.1109/EMBC.2012.6346565.
PubMed 23366526Lin 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.
PubMed 23661321
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Physiotherapy and Rehabilitation System for Lower Body Total Joint Replacement
- ClinicalTrials.gov ID
- NCT02324829
- Acronym / sponsor ID
- ORE 18193
- Conditions
- Lower-body Total Joint Replacement
- Keywords
- Total joint replacement, Physiotherapy, Kalman filtering, Kinematic modeling, Hidden Markov model, Motion segmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Toronto Rehabilitation Institute, Natural Sciences and Engineering Research Council, Canada
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total joint replacement | – | –Patients who has undergone lower body total joint replacement surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specific target audience for sensor deployment is patients who has undergone knee or hip joint replacement and is taking physiotherapy rehabilitation sessions to recover. The target audience of this system is rehabilitation subjects who have recently had knee or hip replacement therapy. We would like to track several subjects over their rehabilitation stay to see the impact of rehabilitation on their movement pattern. Recruitment will be limited to in-patients only, as out-patients tend to be discharged from rehabilitation because they are healthier, and would likely have movement patterns closer to healthy subjects.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Joint angle assessment
Time frame: 2 weeks
Inertial measurement unit (IMU) data will be translated to joint angles via extended Kalman filter and kinematic modeling.
1 secondary outcome
Motion segmentation and identification
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 23174667Lin 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.
- Background: PubMed 23366526Feng-Shun Lin J, Kulic D. Segmenting human motion for automated rehabilitation exercise analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:2881-4. doi: 10.1109/EMBC.2012.6346565.
- Results publication: PubMed 23661321Lin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Kulic, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower-body Total Joint Replacement, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint angle assessment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.