Smartphone Technology to Remotely Measure Postural Sway during Double- and Single-Leg Squats in Adults with Femoroacetabular Impingement and Those with No Hip Pain.

BACKGROUND: The COVID-19 pandemic has accelerated the demand for utilising telehealth as a major mode of healthcare delivery, with increasing interest in the use of tele-platforms for remote patient assessment. In this context, the use of smartphone technology to measure squat performance in people with and without femoroacetabular impingement (FAI) syndrome has not been reported yet. We developed a novel smartphone application, the TelePhysio app, which allows the clinician to remotely connect to the patient's device and measure their squat performance in real time using the smartphone inertial sensors. The aim of this study was to investigate the association and test-retest reliability of the TelePhysio app in measuring postural sway performance during a double-leg (DLS) and single-leg (SLS) squat task. In addition, the study investigated the ability of TelePhysio to detect differences in DLS and SLS performance between people with FAI and without hip pain. METHODS: A total of 30 healthy (nfemales = 12) young adults and 10 adults (nfemales = 2) with diagnosed FAI syndrome participated in the study. Healthy participants performed DLS and SLS on force plates in our laboratory, and remotely in their homes using the TelePhysio smartphone application. Sway measurements were compared using the centre of pressure (CoP) and smartphone inertial sensor data. A total of 10 participants with FAI (nfemales = 2) performed the squat assessments remotely. Four sway measurements in each axis (x, y, and z) were computed from the TelePhysio inertial sensors: (1) average acceleration magnitude from the mean (aam), (2) root-mean-square acceleration (rms), (3) range acceleration (r), and (4) approximate entropy (apen), with lower values indicating that the movement is more regular, repetitive, and predictable. Differences in TelePhysio squat sway data were compared between DLS and SLS, and between healthy and FAI adults, using analysis of variance with significance set at 0.05. RESULTS: The TelePhysio aam measurements on the x- and y-axes had significant large correlations with the CoP measurements (r = 0.56 and r = 0.71, respectively). The TelePhysio aam measurements demonstrated moderate to substantial between-session reliability values of 0.73 (95% CI 0.62-0.81), 0.85 (95% CI 0.79-0.91), and 0.73 (95% CI 0.62-0.82) for aamx, aamy, and aamz, respectively. The DLS of the FAI participants showed significantly lower aam and apen values in the medio-lateral direction compared to the healthy DLS, healthy SLS, and FAI SLS groups (aam = 0.13, 0.19, 0.29, and 0.29, respectively; and apen = 0.33, 0.45, 0.52, and 0.48, respectively). In the anterior-posterior direction, healthy DLS showed significantly greater aam values compared to the healthy SLS, FAI DLS, and FAI SLS groups (1.26, 0.61, 0.68, and 0.35, respectively). CONCLUSIONS: The TelePhysio app is a valid and reliable method of measuring postural control during DLS and SLS tasks. The application is capable of distinguishing performance levels between DLS and SLS tasks, and between healthy and FAI young adults. The DLS task is sufficient to distinguish the level of performance between healthy and FAI adults. This study validates the use of smartphone technology as a tele-assessment clinical tool for remote squat assessment.

Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine: Interim results of a double-blind, randomised controlled phase 1 and 2 trial.

Background: Nanocovax is a recombinant severe acute respiratory syndrome coronavirus 2 subunit vaccine composed of full-length prefusion stabilized recombinant SARS-CoV-2 spike glycoproteins (S-2P) and aluminium hydroxide adjuvant. Methods: We conducted a dose-escalation, open label trial (phase 1) and a randomized, double-blind, placebo-controlled trial (phase 2) to evaluate the safety and immunogenicity of the Nanocovax vaccine (in 25 mcg, 50 mcg, and 75 mcg doses, aluminium hydroxide adjuvanted (0·5 mg/dose) in 2-dose regime, 28 days apart (ClinicalTrials.gov number, NCT04683484). In phase 1, 60 participants received two intramuscular injection of the vaccine following dose-escalation procedure. The primary outcomes were reactogenicity and laboratory tests to evaluate the vaccine safety. In phase 2, 560 healthy adults received either vaccine doses similar in phase 1 (25 or 50 or 75 mcg S antigen in 0·5 mg aluminium per dose) or adjuvant (0·5 mg aluminium) in a ratio of 2:2:2:1. One primary outcome was the vaccine safety, including solicited adverse events for 7 day and unsolicited adverse events for 28 days after each injection as well as serious adverse event or adverse events of special interest throughout the study period. Another primary outcome was anti-S IgG antibody response (Index unit/ml). Secondary outcomes were surrogate virus neutralisation (inhibition percentage), wild-type SARS-CoV-2 neutralisation (dilution fold), and T-cell responses by intracellular staining for interferon gamma (IFNg). Anti-S IgG and neutralising antibody levels were compared with convalescent serum samples from symptomatic Covid-19 patients. Findings: For phase 1 study, no serious adverse events were observed for all 60 participants. Most adverse events were grade 1 and disappeared shortly after injection. For phase 2 study, after randomisation, 480 participants were assigned to receive the vaccine with adjuvant, and 80 participants were assigned to receive the placebo (adjuvant only). Reactogenicity was absent or mild in the majority of participants and of short duration (mean ≤3 days). Unsolicited adverse events were mild in most participants. There were no serious adverse events related to Nanocovax. Regarding the immunogenicity, Nanocovax induced robust anti-S antibody responses. In general, there humoral responses were similar among vaccine groups which reached their peaks at day 42 and declined afterward. At day 42, IgG levels of vaccine groups were 60·48 [CI95%: 51·12-71·55], 49·11 [41·26-58·46], 57·18 [48·4-67·5] compared to 7·10 [6·32-13·92] of convalescent samples. IgG levels reported here can be converted to WHO international standard binding antibody unit (BAU/ml) by multiplying them to a conversion factor of 21·8. Neutralising antibody titre of vaccine groups at day 42 were 89·2 [52·2-152·3], 80·0 [50·8-125.9] and 95·1 [63·1-143·6], compared to 55·1 [33·4-91·0] of the convalescent group. Interpretation: Up to day 90, Nanocovax was found to be safe, well tolerated, and induced robust immune responses. Funding: This work was funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the Ministry of Science and Technology of Vietnam, and Nanogen Pharmaceutical Biotechnology JSC.