Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers

Winfried Ilg; Sarah Milne; Tanja Schmitz-Hübsch; Lisa Alcock; Lukas Beichert; Enrico Bertini; Norlinah Mohamed Ibrahim; Helen Dawes; Christopher M. Gomez; Hasmet Hanagasi; Kirsi M. Kinnunen; Martina Minnerop; Andrea H. Németh; Jane Newman; Yi Shiau Ng; Clara Rentz; Bedia Samanci; Vrutangkumar V. Shah; Susanna Summa; Gessica Vasco; James McNames; Fay B. Horak

doi:10.1007/s12311-023-01625-2

Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers

Winfried Ilg, Sarah Milne, Tanja Schmitz-Hübsch, Lisa Alcock, Lukas Beichert, Enrico Bertini, Norlinah Mohamed Ibrahim, Helen Dawes, Christopher M. Gomez, Hasmet Hanagasi, Kirsi M. Kinnunen, Martina Minnerop, Andrea H. Németh, Jane Newman, Yi Shiau Ng, Clara Rentz, Bedia Samanci, Vrutangkumar V. Shah, Susanna Summa, Gessica VascoJames McNames, Fay B. Horak

Neurology

Research output: Contribution to journal › Review article › peer-review

4 Scopus citations

Abstract

With disease-modifying drugs on the horizon for degenerative ataxias, ecologically valid, finely granulated, digital health measures are highly warranted to augment clinical and patient-reported outcome measures. Gait and balance disturbances most often present as the first signs of degenerative cerebellar ataxia and are the most reported disabling features in disease progression. Thus, digital gait and balance measures constitute promising and relevant performance outcomes for clinical trials. This narrative review with embedded consensus will describe evidence for the sensitivity of digital gait and balance measures for evaluating ataxia severity and progression, propose a consensus protocol for establishing gait and balance metrics in natural history studies and clinical trials, and discuss relevant issues for their use as performance outcomes.

Original language	English (US)
Journal	Cerebellum
DOIs	https://doi.org/10.1007/s12311-023-01625-2
State	Accepted/In press - 2023

Keywords

Cerebellar ataxia
Digital motor performance marker
Gait and posture

ASJC Scopus subject areas

Neurology
Clinical Neurology

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10.1007/s12311-023-01625-2

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Ilg, W., Milne, S., Schmitz-Hübsch, T., Alcock, L., Beichert, L., Bertini, E., Mohamed Ibrahim, N., Dawes, H., Gomez, C. M., Hanagasi, H., Kinnunen, K. M., Minnerop, M., Németh, A. H., Newman, J., Ng, Y. S., Rentz, C., Samanci, B., Shah, V. V., Summa, S., ... Horak, F. B. (Accepted/In press). Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers. Cerebellum. https://doi.org/10.1007/s12311-023-01625-2

Ilg, W, Milne, S, Schmitz-Hübsch, T, Alcock, L, Beichert, L, Bertini, E, Mohamed Ibrahim, N, Dawes, H, Gomez, CM, Hanagasi, H, Kinnunen, KM, Minnerop, M, Németh, AH, Newman, J, Ng, YS, Rentz, C, Samanci, B, Shah, VV, Summa, S, Vasco, G, McNames, J & Horak, FB 2023, 'Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers', Cerebellum. https://doi.org/10.1007/s12311-023-01625-2

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title = "Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers",

abstract = "With disease-modifying drugs on the horizon for degenerative ataxias, ecologically valid, finely granulated, digital health measures are highly warranted to augment clinical and patient-reported outcome measures. Gait and balance disturbances most often present as the first signs of degenerative cerebellar ataxia and are the most reported disabling features in disease progression. Thus, digital gait and balance measures constitute promising and relevant performance outcomes for clinical trials. This narrative review with embedded consensus will describe evidence for the sensitivity of digital gait and balance measures for evaluating ataxia severity and progression, propose a consensus protocol for establishing gait and balance metrics in natural history studies and clinical trials, and discuss relevant issues for their use as performance outcomes.",

keywords = "Cerebellar ataxia, Digital motor performance marker, Gait and posture",

author = "Winfried Ilg and Sarah Milne and Tanja Schmitz-H{\"u}bsch and Lisa Alcock and Lukas Beichert and Enrico Bertini and {Mohamed Ibrahim}, Norlinah and Helen Dawes and Gomez, {Christopher M.} and Hasmet Hanagasi and Kinnunen, {Kirsi M.} and Martina Minnerop and N{\'e}meth, {Andrea H.} and Jane Newman and Ng, {Yi Shiau} and Clara Rentz and Bedia Samanci and Shah, {Vrutangkumar V.} and Susanna Summa and Gessica Vasco and James McNames and Horak, {Fay B.}",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

doi = "10.1007/s12311-023-01625-2",

language = "English (US)",

journal = "Cerebellum",

issn = "1473-4222",

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TY - JOUR

T1 - Quantitative Gait and Balance Outcomes for Ataxia Trials

T2 - Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers

AU - Ilg, Winfried

AU - Milne, Sarah

AU - Schmitz-Hübsch, Tanja

AU - Alcock, Lisa

AU - Beichert, Lukas

AU - Bertini, Enrico

AU - Mohamed Ibrahim, Norlinah

AU - Dawes, Helen

AU - Gomez, Christopher M.

AU - Hanagasi, Hasmet

AU - Kinnunen, Kirsi M.

AU - Minnerop, Martina

AU - Németh, Andrea H.

AU - Newman, Jane

AU - Ng, Yi Shiau

AU - Rentz, Clara

AU - Samanci, Bedia

AU - Shah, Vrutangkumar V.

AU - Summa, Susanna

AU - Vasco, Gessica

AU - McNames, James

AU - Horak, Fay B.

PY - 2023

Y1 - 2023

N2 - With disease-modifying drugs on the horizon for degenerative ataxias, ecologically valid, finely granulated, digital health measures are highly warranted to augment clinical and patient-reported outcome measures. Gait and balance disturbances most often present as the first signs of degenerative cerebellar ataxia and are the most reported disabling features in disease progression. Thus, digital gait and balance measures constitute promising and relevant performance outcomes for clinical trials. This narrative review with embedded consensus will describe evidence for the sensitivity of digital gait and balance measures for evaluating ataxia severity and progression, propose a consensus protocol for establishing gait and balance metrics in natural history studies and clinical trials, and discuss relevant issues for their use as performance outcomes.

AB - With disease-modifying drugs on the horizon for degenerative ataxias, ecologically valid, finely granulated, digital health measures are highly warranted to augment clinical and patient-reported outcome measures. Gait and balance disturbances most often present as the first signs of degenerative cerebellar ataxia and are the most reported disabling features in disease progression. Thus, digital gait and balance measures constitute promising and relevant performance outcomes for clinical trials. This narrative review with embedded consensus will describe evidence for the sensitivity of digital gait and balance measures for evaluating ataxia severity and progression, propose a consensus protocol for establishing gait and balance metrics in natural history studies and clinical trials, and discuss relevant issues for their use as performance outcomes.

KW - Cerebellar ataxia

KW - Digital motor performance marker

KW - Gait and posture

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U2 - 10.1007/s12311-023-01625-2

DO - 10.1007/s12311-023-01625-2

M3 - Review article

AN - SCOPUS:85176468332

SN - 1473-4222

JO - Cerebellum

JF - Cerebellum

ER -

Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers

Abstract

Keywords

ASJC Scopus subject areas

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