Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001248257p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2018
Date registered
24/07/2018
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysing how a new, robotic knee orthosis impacts the gait pattern of a healthy individual
Scientific title
Analysing how a new, robotic knee orthosis impacts the gait pattern of a healthy individual
Secondary ID [1] 295099 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial Compartmental Osteoarthritis 308165 0
Condition category
Condition code
Musculoskeletal 307204 307204 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name of intervention: Quasi-passive knee orthosis

Healthy participants will be asked to wear a quasi-passive knee orthosis which has been developed by the team. The device is attached to the participant's right leg by applying straps. The participants will be provided information regarding the procedure through a participant information and consent form.
The procedure of the test involves qualitative and quantitative analysis. The trial procedure is described as follows:
1) Anthropometric measurements of the participant's right leg will be taken for fitting the device.
2) Up to 26 reflective markers will be taped on the joints of the feet, legs, pelvis and trunk.
3) The participant will be asked to walk barefoot over the 2 Kistler force plates a total of 10 times (5 times for each leg).
4) The participant will then put their shoes on and walk 10m ten times.
5) The participant will then wear the device which will be aligned to the participant's knee.
6) Walk a distance of 10m ten times to test fitting and comfort and to determine changes in their gait pattern due to the device.
7) The device is switched on and the participant walks 10m ten times again.
The gait information is recorded using 8 VICON cameras and 2 Kistler force plates. This information is used for quantitative analysis of the effects of the device on the participant's natural gait pattern. A questionnaire will be provided after this test to obtain qualitative information regarding comfort and feedback on how the device performed (if they could feel the forces exerted by the device),

The intervention study will be conducted by a research team formed of 3 engineering PhD students, an engineering research assistant and their supervisor specialising in the field of robotics from Monash University, as well as a biomechanist from Monash Health.

The quasi-passive knee orthosis will be physically tested on 15 individual participants at the Kingston Gait Laboratory.

The quasi-passive knee orthosis will be attached to each participant once over a 2-3 hour period.

The quasi-passive knee orthosis needs to be personalised for each individual participant to ensure that it fits the individual's leg, maximise comfort and that the device is acting similarly on each participant. This will be done through the use of padding that can be changed according to the participant's leg size. Straps are also used to ensure that the device fits snugly onto the participant's leg.

As the clinical trial is to analyse "how a new, robotic knee orthosis impacts the gait pattern of a healthy individual", the output of the device (applied forces and moments), as well as the gait pattern of the individual will be measured to validate the conceptual design and to pave a path for future improvements. This analysis will be done by the whole research team.
Intervention code [1] 301430 0
Behaviour
Comparator / control treatment
The individual gait pattern will be used as the control. The natural gait pattern will be recorded in the gait laboratory and be compared with gait pattern when the quasi-passive knee orthosis is worn but turned off as well as when the orthosis is worn and turned on.
Control group
Active

Outcomes
Primary outcome [1] 306178 0
Provision of extension and flexion moments by the quasi-passive knee orthosis (composite outcome).
This outcome is assessed by analysing the data gathered by the sensors on the quasi-passive knee orthosis.
Timepoint [1] 306178 0
During the gait laboratory test when the quasi-passive knee orthosis is worn while the mechanism is engaged.
Primary outcome [2] 306179 0
Provision of adduction moments by the quasi-passive knee orthosis.
This ground reaction force will be measured using the two Kistler force plates situated beneath the floor along the test walkway. The ground reaction force will be used as an input parameter to the inverse dynamics process to solve for the moments required for each joint to actuate the body.
Timepoint [2] 306179 0
During the test when the quasi-passive knee orthosis is worn while the mechanism is unengaged and while the mechanisms are engaged.
Primary outcome [3] 306180 0
Changes in the hip, knee and ankle kinematics while the device is worn as compared to natural walking (composite outcome).
The joint kinematics will be measured using the Vicon system and these measurements will be used in conjunction with the ground reaction forces for the inverse dynamics calculation. The kinematics measurements from the normal walking (without the qausi-passive knee orthosis) will be compared with the measurements obtained while the participants walks while wearing the device before and after it is engaged to determine difference in the gait pattern caused by the quasi-passive knee orthosis.
Timepoint [3] 306180 0
During the test when the quasi-passive knee orthosis is worn while the mechanism is unengaged and while the mechanisms are engaged.
Secondary outcome [1] 347769 0
Device comfortable to wear for the duration of the test (up to 3 hours). The results will be assessed using a Likert scale.
Timepoint [1] 347769 0
Asked about comfort during the rest periods during the test. A questionnaire with a Likert Scale designed specifically for this study will be provided at the end of the test.

Eligibility
Key inclusion criteria
People with no medical conditions affecting their natural gait pattern.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- People with medical conditions that affect their natural gait patterns.
- People that are overweight

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of fifteen participants has been determined as sufficient for this preliminary proof of concept study. Results from this study may then be used to calculate the number of participants required for the next phase of the project.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22895 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 299680 0
Government body
Name [1] 299680 0
Australian Research Council
Country [1] 299680 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ZS Industries Co. Ltd.
Address
R602, Building 3, No. 695 Lingshi Rd., Shanghai, 200072
Country
China
Secondary sponsor category [1] 299017 0
None
Name [1] 299017 0
Address [1] 299017 0
Country [1] 299017 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300580 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 300580 0
Ethics committee country [1] 300580 0
Australia
Date submitted for ethics approval [1] 300580 0
16/05/2018
Approval date [1] 300580 0
Ethics approval number [1] 300580 0

Summary
Brief summary
The primary purpose of this study is to validate the quasi-passive knee orthosis' functionality to allow further work

It is hypothesized that:
- When walking with the quasi-passive knee orthosis, while the leg wearing the orthosis is on the ground, the device will provide bending loads in 2 axes to reduce the loading on the knee.
- Hip, knee, and ankle kinematics will remain unchanged.
- The quasi-passive knee orthosis will be comfortable for the user to wear for an extended period of time and will have no soreness after use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84118 0
Dr Anna Murphy
Address 84118 0
Monash Health
400 Warrigal Rd, Cheltenham VIC 3192
Country 84118 0
Australia
Phone 84118 0
+61 3 9265 1453
Fax 84118 0
+61 3 9265 1577
Email 84118 0
[email protected]
Contact person for public queries
Name 84119 0
Mr Godfrey Keung
Address 84119 0
Monash University
17 Alliance lane, Clayton, 3800, Victoria
Country 84119 0
Australia
Phone 84119 0
+61 4 05065238
Fax 84119 0
Email 84119 0
[email protected]
Contact person for scientific queries
Name 84120 0
Dr Anna Murphy
Address 84120 0
Monash Health
400 Warrigal Rd, Cheltenham VIC 3192
Country 84120 0
Australia
Phone 84120 0
+61 3 9265 1453
Fax 84120 0
+61 3 9265 1577
Email 84120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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