Gait, Unsteady Clinical Trial
Official title:
Perioperative Case Series: Qualitative Evaluation of Gait Cycle and Ground in Knee
NCT number | NCT04268680 |
Other study ID # | OpenGO |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 7, 2017 |
Est. completion date | June 8, 2018 |
Verified date | February 2020 |
Source | Istituto Ortopedico Galeazzi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Gait analysis is a quick and powerful tool with a wide range of clinical applications in
various fields. However, due to the expensive and highly specialized equipment required, gait
studies are mostly limited to academic research centers and small sample sizes and no
large-scale, randomized controlled trials have been performed. Several authors have proposed
inexpensive accelerometer-based systems to remedy this situation. Through mathematic
transformation they adequately measure step time and length. With these systems however only
temporal spatial gait parameters can be recorded; kinetic gait parameters, such as ground
reaction force, cannot be measured. As these kinetic parameters are important for clinical
studies, especially in fracture and rehabilitation research different methods are needed. Its
availability is mainly limited to research centers, conventional gait analysis is further
hindered by its stationarity and that it only allows momentary views of the patient's gait in
a confined research environment. Even smaller, wearable systems have to be attached to an
external apparatus, or are limited by their battery capacity, data storage and other device
specific factors. Furthermore, the use of these systems is at an early clinical stage and
their full potential not yet developed. As most disease processes are continuous, tools with
long-term, continuous measuring capabilities are needed. For this reason a new
pressure-measuring insole with built in battery and data storage was developed in cooperation
with the AO Foundation(AO Foundation, Davos, Switzerland). The system offers complete
independence from any external measures for up to 4 weeks and monitors a patient step during
this time.
The purpose of this pilot study is to investigate which how TKA arthroplasty may impact gait
during early and medium term rehabilitation phase. This will be done through the use of the
OpenGo Sensor Insole (Moticon GmbH).
Status | Completed |
Enrollment | 6 |
Est. completion date | June 8, 2018 |
Est. primary completion date | January 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - primary TKA - 45-75 years of age (included) - skeletally mature - willing and able to participate in required pre-op and follow-up visits at the investigational site and to complete study procedures and questionnaires - consented to participating in the study by signing the IRB/EC approved informed consent form - BMI <32 Exclusion Criteria: - symptomatic/debilitating co-commitant arthropathy of non-operative joints (e.g. a TKA patient cannot have advanced arthritis of the contralateral knee or ipsilateral hip/ankle) that would impede or otherwise confuse the peri-operative measurement of gait. - Significant comorbidities that would impede the patients ability to participate in standard recovery and rehabilitation |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Galeazzi | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative Case Series: clinical evaluation of gait cycle and ground in Knee arthroplasty patients | Evaluation of gait cycle and ground in primary TKA patients compared to the healthy contralateral limb. | baseline to 3 month | |
Secondary | Perioperative Case Series: qualitative evaluation of gait cycle and ground in Knee arthroplasty patients | Easy of use. Qualitative user (HCP and patient) feedback on experience using and wearing the insoles | baseline to 3 month |
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