GaitSmart motion analysis compared to commonly used function outcome measures in the IMI-APPROACH knee osteoarthritis cohort.

Background: There are multiple measures for assessment of physical function in knee osteoarthritis (OA), but each has its strengths and limitations. The GaitSmart® system, which uses inertial measurement units (IMUs), might be a user-friendly and objective method to assess function. This study evaluates the validity and responsiveness of GaitSmart® motion analysis as a function measurement in knee OA and compares this to Knee Injury and Osteoarthritis Outcome Score (KOOS), Short Form 36 Health Survey (SF-36), 30s chair stand test, and 40m self-paced walk test.
Methods: The 2-year Innovative Medicines Initiative-Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) knee OA cohort was conducted between January 2018 and April 2021. For this study, available baseline and 6 months follow-up data (n = 262) was used. Principal component analysis was used to investigate whether above mentioned function instruments could represent one or more function domains. Subsequently, linear regression was used to explore the association between GaitSmart® parameters and those function domains. In addition, standardized response means, effect sizes and t-tests were calculated to evaluate the ability of GaitSmart® to differentiate between good and poor general health (based on SF-36). Lastly, the responsiveness of GaitSmart® to detect changes in function was determined.
Results: KOOS, SF-36, 30s chair test and 40m self-paced walk test were first combined into one function domain (total function). Thereafter, two function domains were substracted related to either performance based (objective function) or self-reported (subjective function) function. Linear regression resulted in the highest R2 for the total function domain: 0.314 (R2 for objective and subjective function were 0.252 and 0.142, respectively.). Furthermore, GaitSmart® was able to distinguish a difference in general health status, and is responsive to changes in the different aspects of objective function (Standardized response mean (SRMs) up to 0.74).
Conclusion: GaitSmart® analysis can reflect performance based and self-reported function and may be of value in the evaluation of function in knee OA. Future studies are warranted to validate whether GaitSmart® can be used as clinical outcome measure in OA research and clinical practice.
Competing Interests: The IMI-APPROACH project received a grant from Innovative Medicines Institute, grant agreement 115770. Outside the submitted work: DH is founder and technical director of GaitSmart®. MK reports personal fees from consultancy (Abbvie, Pfizer, Levicept, GlaxoSmithKline, Merck-Serono, Kiniksa, Flexion) and local investigator of industry-driven trial (Abbvie), grant from Dutch Society of Rheumatology and Pfizer, royalties from Wolters Kluwer (UptoDate), Springer Verlag (Reumatologie en klinische immunologie). FJB reports grants from Abbvie, Ablynx N.V., Amgen, Archigen Biotech Limited, Boehringer, Bristol-Meyers, Celgene INt., Eli Lilly and Company, F.Hoffman-La Roche Lyd. Galapagos, Gedeon, Gideal Sciences NC, GlaxoSmithKline, Hospira, INC Research UK Ltd., Inventiv Health Clinical, Janssen, Lilly, Nichi-IKO Pharmaceutical, Novartis, ONO Pharma, Pfizer, Pharmaceutical research, Regeneron, Roche, SA UCB Pharma, Sanofi, TRB CHemedica, USB Biosciences GMBH, and patents for ‘Method for the diagnosing Osteoarthritis’; 15847971.1 (2017), 2,978,169 (2017), 15/540,249 (2017), and for ‘nti-connexin compounds for use in the prevention and/or treatment of degenerative joint disease’; P201731233 (2017). IH reports personal fees from AbbVie, and grants from Pfizer. FB reports personal fees from Boehringer, Bone Therapeutics, Expanscience, Galapagos, Gilead, GSK, Merck Sereno, MSD, Nordic, Novartis, Pfizer, Regulaxis, Roche, Sandoz, Sanofi, Servier, UCB, Peptinov, TRB Chemedica, 4P Pharma. This does not alter our adherence to PLOS ONE policies on sharing data and materials.