Nejvíce citovaný článek - PubMed ID 39706632
Safety and efficacy of intrathecal antibodies to Nogo-A in patients with acute cervical spinal cord injury: a randomised, double-blind, multicentre, placebo-controlled, phase 2b trial
BackgroundThe aim of clinical trials for spinal cord injury (SCI) is to improve everyday-life activity outcomes, which requires reliable methods for monitoring patient activity. This study evaluates sensor-derived activity metrics in comparison to established clinical assessment methods.MethodsWearable inertial sensors collected data from 69 individuals with acute, traumatic cervical SCI participating in the Nogo-A Inhibition in Spinal Cord Injury trial (NCT03935321), a phase 2b, multicenter, randomized, placebo-controlled trial. During inpatient rehabilitation, participants wore up to 5 inertial sensors for up to 3 consecutive days each week. An estimation of average daily energy expenditure (EE) was used as an indicator of physical activity and compared to the recovery of Upper Extremity Motor Scores (UEMS) and Spinal Cord Independence Measures (SCIM).ResultsParticipants in the verum (n = 41; 59.4%) and placebo (n = 28; 40.6%) groups showed similar initial activity levels, however, the verum group exhibited a significantly greater weekly increase in average daily EE (ΔEE = 11.6 kcal/day/week, 95% CI [1.5, 21.8], P = .025). In contrast, no significant group differences were observed in changes in UEMS (ΔUEMS = 0.1/week, 95% CI [-0.2, 0.3], P = .603) or SCIM (ΔSCIM = 0.2, per week 95% CI [-0.7, 1.1], P = .644).ConclusionContinuous sensor-based activity monitoring offers objective and sensitive insights into changes in physical capabilities, effectively complementing periodic clinical assessments. Thus, sensor-derived outcome measures offer potential for improving the evaluation of clinical studies in individuals with SCI.Clinical Trail Registration:https://clinicaltrials.gov; NCT03935321.
- Klíčová slova
- IMUs, daily activity monitoring, energy expenditure, inertial measurement units, spinal cord injury,
- MeSH
- akcelerometrie * přístrojové vybavení MeSH
- činnosti denního života * MeSH
- dospělí MeSH
- energetický metabolismus * fyziologie MeSH
- hodnocení výsledků zdravotní péče * MeSH
- lidé středního věku MeSH
- lidé MeSH
- nositelná elektronika * MeSH
- poranění míchy * rehabilitace patofyziologie MeSH
- studie proveditelnosti MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: In the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), motor levels are inferred from sensory levels for high cervical, thoracic, and low sacral injuries, as key muscles are only assessed in upper and lower extremities. This is known as the "motor follows sensory level" rule. OBJECTIVES: To develop regression models for estimating motor scores from sensory scores in segments without clinically testable key muscles and to validate the consensus-based "motor follows sensory level" approach. METHODS: A total of 6940 ISNCSCI examinations from the European Multicenter Study about Spinal Cord Injury were reviewed. Multiple linear and random forest regression models were trained on scores in clinically testable segments to predict motor from sensory scores of the same spinal segment and side. Models based on ipsilateral light touch or pinprick scores alone, as well as all bilateral sensory scores, were also evaluated. Predicted motor scores were used to recalculate motor levels for the segments without clinically testable key muscles and compared to the true motor levels. RESULTS: The ipsilateral regression models showed minimal differences (R 2 0.64-0.65; RMSE 1.34). Normal motor scores were predicted only for normal sensory function; in the linear model, this was captured by the equation: motor score = 0.18 + 1.22 * light touch score + 0.96 * pinprick score. Model-based motor levels were shifted caudally 0.18 segments (linear regression) and 0.32 segments (random forest regression). CONCLUSION: As models predict normal motor function only for normal sensory scores, predicted motor levels deviate only marginally, supporting the "motor follows sensory level" rule.
- Klíčová slova
- ISNCSCI, machine learning, motor level, motor score estimation, multiple linear regression, random forest regression, spinal cord injury,
- MeSH
- dospělí MeSH
- kosterní svaly * patofyziologie MeSH
- lidé MeSH
- neurologické vyšetření * normy MeSH
- poranění míchy * klasifikace patofyziologie diagnóza MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH