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Analysing how a new, robotic knee orthosis impacts the gait pattern of a healthy individual

Analysing how a new, robotic knee orthosis impacts the gait pattern of a healthy individual

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001248257
Enrollment
15
Registered
2018-07-24
Start date
2018-10-15
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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) Anthropometri

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.

Sponsors

ZS Industries Co. Ltd.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

People with no medical conditions affecting their natural gait pattern.

Exclusion criteria

- People with medical conditions that affect their natural gait patterns. - People that are overweight

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026