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Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
by
Mohamed Ibrahim, Norlinah
, Newman, Jane
, Shah, Vrutangkumar V.
, Hanagasi, Hasmet
, Ng, Yi Shiau
, Rentz, Clara
, Ilg, Winfried
, Schmitz-Hübsch, Tanja
, Vasco, Gessica
, Summa, Susanna
, Dawes, Helen
, Alcock, Lisa
, Bertini, Enrico
, Minnerop, Martina
, Samanci, Bedia
, Kinnunen, Kirsi M.
, Milne, Sarah
, Gomez, Christopher M.
, Horak, Fay B.
, Németh, Andrea H.
, Beichert, Lukas
, McNames, James
in
Ataxia
/ Ataxia - diagnosis
/ Balance
/ Biomarkers
/ Biomedical and Life Sciences
/ Biomedicine
/ Cerebellar ataxia
/ Cerebellar Ataxia - diagnosis
/ Cerebellar Ataxia - drug therapy
/ Cerebellar Ataxia - physiopathology
/ Cerebellar Ataxia - therapy
/ Cerebellum
/ Clinical outcomes
/ Clinical trials
/ Clinical Trials as Topic - methods
/ Clinical Trials as Topic - standards
/ Consensus
/ Disease
/ Gait
/ Gait - physiology
/ Gait Analysis - methods
/ Gait Disorders, Neurologic - diagnosis
/ Gait Disorders, Neurologic - physiopathology
/ Gait Disorders, Neurologic - therapy
/ Humans
/ Natural history
/ Neurobiology
/ Neurology
/ Neurosciences
/ Postural Balance - physiology
/ Quality of life
/ Regulatory approval
/ Review
/ Sensitivity analysis
/ Working groups
2024
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Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
by
Mohamed Ibrahim, Norlinah
, Newman, Jane
, Shah, Vrutangkumar V.
, Hanagasi, Hasmet
, Ng, Yi Shiau
, Rentz, Clara
, Ilg, Winfried
, Schmitz-Hübsch, Tanja
, Vasco, Gessica
, Summa, Susanna
, Dawes, Helen
, Alcock, Lisa
, Bertini, Enrico
, Minnerop, Martina
, Samanci, Bedia
, Kinnunen, Kirsi M.
, Milne, Sarah
, Gomez, Christopher M.
, Horak, Fay B.
, Németh, Andrea H.
, Beichert, Lukas
, McNames, James
in
Ataxia
/ Ataxia - diagnosis
/ Balance
/ Biomarkers
/ Biomedical and Life Sciences
/ Biomedicine
/ Cerebellar ataxia
/ Cerebellar Ataxia - diagnosis
/ Cerebellar Ataxia - drug therapy
/ Cerebellar Ataxia - physiopathology
/ Cerebellar Ataxia - therapy
/ Cerebellum
/ Clinical outcomes
/ Clinical trials
/ Clinical Trials as Topic - methods
/ Clinical Trials as Topic - standards
/ Consensus
/ Disease
/ Gait
/ Gait - physiology
/ Gait Analysis - methods
/ Gait Disorders, Neurologic - diagnosis
/ Gait Disorders, Neurologic - physiopathology
/ Gait Disorders, Neurologic - therapy
/ Humans
/ Natural history
/ Neurobiology
/ Neurology
/ Neurosciences
/ Postural Balance - physiology
/ Quality of life
/ Regulatory approval
/ Review
/ Sensitivity analysis
/ Working groups
2024
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Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
by
Mohamed Ibrahim, Norlinah
, Newman, Jane
, Shah, Vrutangkumar V.
, Hanagasi, Hasmet
, Ng, Yi Shiau
, Rentz, Clara
, Ilg, Winfried
, Schmitz-Hübsch, Tanja
, Vasco, Gessica
, Summa, Susanna
, Dawes, Helen
, Alcock, Lisa
, Bertini, Enrico
, Minnerop, Martina
, Samanci, Bedia
, Kinnunen, Kirsi M.
, Milne, Sarah
, Gomez, Christopher M.
, Horak, Fay B.
, Németh, Andrea H.
, Beichert, Lukas
, McNames, James
in
Ataxia
/ Ataxia - diagnosis
/ Balance
/ Biomarkers
/ Biomedical and Life Sciences
/ Biomedicine
/ Cerebellar ataxia
/ Cerebellar Ataxia - diagnosis
/ Cerebellar Ataxia - drug therapy
/ Cerebellar Ataxia - physiopathology
/ Cerebellar Ataxia - therapy
/ Cerebellum
/ Clinical outcomes
/ Clinical trials
/ Clinical Trials as Topic - methods
/ Clinical Trials as Topic - standards
/ Consensus
/ Disease
/ Gait
/ Gait - physiology
/ Gait Analysis - methods
/ Gait Disorders, Neurologic - diagnosis
/ Gait Disorders, Neurologic - physiopathology
/ Gait Disorders, Neurologic - therapy
/ Humans
/ Natural history
/ Neurobiology
/ Neurology
/ Neurosciences
/ Postural Balance - physiology
/ Quality of life
/ Regulatory approval
/ Review
/ Sensitivity analysis
/ Working groups
2024
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Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
Journal Article
Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers
2024
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Overview
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.
Publisher
Springer US,Springer Nature B.V
Subject
/ Balance
/ Biomedical and Life Sciences
/ Cerebellar Ataxia - diagnosis
/ Cerebellar Ataxia - drug therapy
/ Cerebellar Ataxia - physiopathology
/ Clinical Trials as Topic - methods
/ Clinical Trials as Topic - standards
/ Disease
/ Gait
/ Gait Disorders, Neurologic - diagnosis
/ Gait Disorders, Neurologic - physiopathology
/ Gait Disorders, Neurologic - therapy
/ Humans
/ Postural Balance - physiology
/ Review
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