Validation study of the Overall Neuropathy Limitations Scale (ONLS) in Russia
- Authors: Tsaregorodtsev D.S.1, Yusupova D.G.1, Morozova S.N.1, Grishina D.A.1, Zaytsev A.B.2, Zimin A.A.1, Polekhina N.V.1, Stokley R.3, Krotenkova M.V.1, Suponeva N.A.1
-
Affiliations:
- Russian Center of Neurology and Neurosciences
- I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
- University of Lancashire
- Issue: Vol 16, No 2 (2026)
- Pages: 21-31
- Section: ORIGINAL REPORTS
- Published: 21.09.2026
- URL: https://nmb.abvpress.ru/jour/article/view/688
- DOI: https://doi.org/10.17650/2222-8721-2026-16-2-21-31
- ID: 688
Cite item
Abstract
Background. Polyneuropathies are a heterogeneous group of peripheral nervous system disorders associated with sensory and motor impairment and often leading to disability. Validated assessment tools adapted to specific populations are required to evaluate functional limitations. Although the Overall Neuropathy Limitations Scale (ONLS) is widely used internationally, it has not been validated in a Russian-speaking population.
Aim. To perform cross-cultural adaptation of the original ONLS and to evaluate the psychometric properties of the developed Russian-language version.
Materials and methods. The study enrolled 60 patients with polyneuropathies: hereditary motor and sensory neuropathy (30 patients), chronic inflammatory demyelinating polyneuropathy (15 patients), and diabetic polyneuropathy (15 patients). The methodology included cross-cultural adaptation of the scale (involving 15 patients in the pilot phase), as well as analysis of its reliability, validity, and sensitivity.
Results. A Russian-language version of the ONLS was developed. The tool demonstrated high content validity and criterion validity against the INCAT (Inflammatory Neuropathy Cause and Treatment) scale (r = 0.99), excellent inter-rater reliability and test-retest reliability (intraclass correlation coefficient is 0.97 and 0.99, respectively), as well as high sensitivity in patients with chronic inflammatory demyelinating polyneuropathies (standardized response mean –0.72; Cohen’s d = 0.83).
Conclusion. The Russian-language version of the ONLS possesses strong psychometric properties and can be recommended for evaluating functional limitations in patients with polyneuropathies of various etiologies in both clinical and research settings.
About the authors
D. S. Tsaregorodtsev
Russian Center of Neurology and Neurosciences
Author for correspondence.
Email: tsaregorodtsev.dmitri@yandex.ru
ORCID iD: 0009-0009-4851-9649
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
D. G. Yusupova
Russian Center of Neurology and Neurosciences
Email: dzhamilya-d@mail.ru
ORCID iD: 0000-0002-5826-9112
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
S. N. Morozova
Russian Center of Neurology and Neurosciences
Email: kulikovasn@gmail.com
ORCID iD: 0000-0002-9093-344X
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
D. A. Grishina
Russian Center of Neurology and Neurosciences
Email: dgrishina82@gmail.com
ORCID iD: 0000-0002-7924-3405
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
A. B. Zaytsev
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)
Email: tsaregorodtsev.dmitri@yandex.ru
ORCID iD: 0000-0003-3774-3070
Russian Federation, Build. 2, 8 Trubetskaya St., Moscow 119991
A. A. Zimin
Russian Center of Neurology and Neurosciences
Email: leha-zimin@inbox.ru
ORCID iD: 0000-0002-9226-2870
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
N. V. Polekhina
Russian Center of Neurology and Neurosciences
Email: tsaregorodtsev.dmitri@yandex.ru
ORCID iD: 0000-0002-4364-5947
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
R. Stokley
University of Lancashire
Email: rstockley1@uclan.ac.uk
ORCID iD: 0000-0003-4441-6860
United Kingdom, Fylde Road, Preston PR1 2HE
M. V. Krotenkova
Russian Center of Neurology and Neurosciences
Email: krotenkovamv@neurology.ru
ORCID iD: 0000-0003-3820-4554
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
N. A. Suponeva
Russian Center of Neurology and Neurosciences
Email: tsaregorodtsev.dmitri@yandex.ru
ORCID iD: 0000-0003-3956-6362
Russian Federation, 80 Volokolamskoe Shosse, Моscow 125367
References
- England J.D., Gronseth G.S., Franklin G. et al. American Academy of Neurology; American Association of Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 2005;64(2):199–207. doi: 10.1212/01.WNL.0000149522.32823.EA
- Hanewinckel R., van Oijen M., Ikram M.A. et al. The epidemiology and risk factors of chronic polyneuropathy. Eur J Epidemiol 2016;31(1):5–20. doi: 10.1007/s10654-015-0094-6
- England J.D., Asbury A.K. Peripheral neuropathy. Lancet 2004;363(9427):2151–61. doi: 10.1016/S0140-6736(04)16508-2
- Callaghan B.C., Price R.S., Feldman E.L. Distal symmetric polyneuropathy: a review. JAMA 2015;314(20):2172–81. doi: 10.1001/jama.2015.13611
- Пирадов М.А., Супонева Н.А., Гришина Д.А. Полинейропатии: алгоритмы диагностики и лечения. М.: Горячая линия – Телеком, 2019. 248 с. Piradov M.A., Suponeva N.A., Grishina DA. Polineuropathies: Diagnostic and Treatment Algorithms. Moscow: Goryachaya Liniya – Telekom, 2019. 248 p. (In Russ.).
- Van Nes S.I., Vanhoutte E.K., van Doorn P.A. et al. Rasch-built Overall Disability Scale (R-ODS) for immune-mediated peripheral neuropathies. Neurology 2011;76(4):337–45. doi: 10.1212/WNL.0b013e318208824b
- Breiner A., Barnett C., Bril V. INCAT disability score: a critical analysis of its measurement properties. Muscle Nerve 2014;50(2):164–9. doi: 10.1002/mus.24207
- Bhandari V., Abraham A., Lovblom L.E. et al. Single simple question in axonal polyneuropathy. Muscle Nerve 2024;70(4):824–30. doi: 10.1002/mus.28209
- Арестова А.С., Мельник Е.А., Зайцев А.Б. и др. Шкала «Этиология и лечение воспалительной нейропатии» (Inflammatory Neuropathy Cause and Treatment, INCAT) для оценки степени инвалидизации у больных хронической воспалительной демиелинизирующей полинейропатией: лингвокультурная адаптация в России. Нервно-мышечные болезни 2021;11(4):26–33. doi: 10.17650/2222-8721-2021-11-4-26-33 Arestova А.S., Melnik Е.А., Zaytsev A.B. et al. Inflammatory Neuropathy Cause and Treatment (INCAT) Scale for the assessment of disability level in patients with chronic inflammatory demyelinating polyneuropathy: linguocultural ratification in Russia. Nervno-myshechnye bolezni = Neuromuscular Diseases 2021;11(4):26–33. (In Russ.). doi: 10.17650/2222-8721-2021-11-4-26-33
- Супонева Н.А., Арестова А.С., Мельник Е.А. и др. Валидация шкалы суммарной оценки мышечной силы (MRC sum score) для использования у русскоязычных пациентов с хронической воспалительной демиелинизирующей полинейропатией. Нервно-мышечные болезни 2023;13(1):68–74. doi: 10.17650/2222-8721-2023-13-1-68-74 Suponeva N.A., Arestova A.S., Melnik E.A. et al. Validation of the Medical Research Council sum score (MRCss) for use in Russian-speaking patients with chronic inflammatory demyelinating polyneuropathy. Nervno-myshechnye bolezni = Neuromuscular Diseases 2023;13(1):68–74. (In Russ.). doi: 10.17650/2222-8721-2023-13-1-68-74
- Супонева Н.А., Мельник Е.А., Арестова А.С. и др. Валидация опросника для оценки качества жизни пациентов с хронической приобретенной полинейропатией (Chronic Acquired Polyneuropathy – Patient Reported Index, CAP-PRI) в России. Нервно-мышечные болезни 2022;12(3):17–25. doi: 10.17650/2222-8721-2022-12-3-17-25 Suponeva N.A., Melnik E.A., Arestova A.S. et al. Validation Chronic Acquired Polyneuropathy – Patient Reported Index (CAP-PRI) in Russia for CIDP patients. Nervno-myshechnye bolezni = Neuromuscular Diseases 2022;12(3):17–25. (In Russ.). doi: 10.17650/2222-8721-2022-12-3-17-25
- Супонева Н.А., Арестова А.С., Мельник Е.А. и др. Валидация шкалы степени невропатических нарушений (Neuropathy Impairment Score, NIS) для использования у русскоязычных пациентов с хронической воспалительной демиелинизирующей полинейропатией. Нервно-мышечные болезни 2024;14(4):29–39. doi: 10.17650/2222-8721-2024-14-4-29-39 Suponeva N.A., Arestova A.S., Melnik E.A. et al. Validation of the Neuropathy Impairment Score (NIS) for use in Russian-speaking patients with chronic inflammatory demyelinating polyneuropathy. Nervno-myshechnye bolezni = Neuromuscular Diseases 2024;14(4):29–39. (In Russ.). doi: 10.17650/2222-8721-2024-14-4-29-39
- Rajabally YA, Ghasemi M. Comparative value and determinants of suitability of outcome measures in treated chronic inflammatory demyelinating polyneuropathy. Muscle Nerve 2020;61(2):182–6. doi: 10.1002/mus.26747
- Mandel J., Bertrand V., Lehert P. et al. A meta-analysis of randomized double-blind clinical trials in CMT1A to assess the change from baseline in CMTNS and ONLS scales after one year of treatment. Orphanet J Rare Dis 2015;10:74. doi: 10.1186/s13023-015-0293-y
- Graham R.C., Hughes R.A. A modified peripheral neuropathy scale: the Overall Neuropathy Limitations Scale. J Neurol Neurosurg Psychiatry 2006;77(8):973–6. doi: 10.1136/jnnp.2005.081547
- Solari A., Laura M., Salsano E. et al. Reliability of clinical outcome measures in Charcot–Marie–Tooth disease. Neuromuscul Disord 2008;18(1):19–26. doi: 10.1016/j.nmd.2007.09.006
- Niu H.X., Wang R.H., Xu H.L. et al. Nine-hole peg test and ten-meter walk test for evaluating functional loss in Chinese Charcot–Marie–Tooth disease. Chin Med J (Engl) 2017;130(15):1773–8. doi: 10.4103/0366-6999.211550
- Zis P., Hadjivassiliou M., Rao D.G. et al. Electrophysiological determinants of the clinical severity of axonal peripheral neuropathy. Muscle Nerve 2019;59(4):491–3. doi: 10.1002/mus.26425
- Mokkink L.B., Elsman E.B.M., Terwee C.B. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Qual Life Res 2024;33(11):2929–39. doi: 10.1007/s11136-024-03761-6
- Keddie S., Foldes D., Caimari F. et al. Clinical characteristics, risk factors, and outcomes of POEMS syndrome: a longitudinal cohort study. Neurology 2020;95(3):e268–79. doi: 10.1212/WNL.17.09.2026009940
- Zis P., Sarrigiannis P.G., Rao D.G. et al. Chronic idiopathic axonal polyneuropathy: Prevalence of pain and impact on quality of life. Brain Behav 2019;9(1):e01171. doi: 10.1002/brb3.1171
- Alcantara M., Mannan S., de la Cruz J. et al. Value of multi-modality small fiber assessments in a genotypically diverse cohort of transthyretin-related amyloidosis in the early stages of disease. Med Clin (Barc) 2024;162(12):e64–9. doi: 10.1016/j.medcli.2024.02.012
- Rajabally Y.A., Nazeer K.K., Min Y.G. Minimal clinically important differences in measuring treatment effects in CIDP: history, current use, limitations, and prospects. Muscle Nerve 2025;72(5):1042–51. doi: 10.1002/mus.28478
- Rajabally Y.A., Min Y.G., Nazeer K.K. et al. Treatment response amplitude and timing in chronic inflammatory demyelinating polyneuropathy with routine care: study of a UK cohort. Eur J Neurol 2024;31(10):e16399. doi: 10.1111/ene.16399
- Pareyson D., Reilly M.M., Schenone A. et al. Ascorbic acid in Charcot–Marie–Tooth disease type 1A (CMT-TRIAAL and CMT-TRAUK): a double-blind randomised trial. Lancet Neurol 2011;10(4):320–8. doi: 10.1016/S1474-4422(11)70025-4
- Dyck P.J., Davies J.L., Litchy W.J. et al. Longitudinal assessment of diabetic polyneuropathy using a composite score in the Rochester Diabetic Neuropathy Study cohort. Neurology 1997;49(1):229–39. doi: 10.1212/wnl.49.1.229
- Vanhoutte E.K., Faber C.G., Merkies I.S., PeriNomS study group. 196th ENMC international workshop: outcome measures in inflammatory peripheral neuropathies. 8–10 February 2013, Naarden, The Netherlands. Neuromuscul Disord 2013;23(11):924–33. doi: 10.1016/j.nmd.2013.06.006
Supplementary files


