Digital endpoints for self-administered home-based functional assessment in pediatric Friedreich's ataxia.


Journal

Annals of clinical and translational neurology
ISSN: 2328-9503
Titre abrégé: Ann Clin Transl Neurol
Pays: United States
ID NLM: 101623278

Informations de publication

Date de publication:
09 2021
Historique:
revised: 16 07 2021
received: 14 05 2021
accepted: 17 07 2021
pubmed: 7 8 2021
medline: 24 2 2022
entrez: 6 8 2021
Statut: ppublish

Résumé

Friedreich's ataxia is an inherited, progressive, neurodegenerative disease that typically begins in childhood. Disease severity is commonly assessed with rating scales, such as the modified Friedreich's Ataxia Rating Scale, which are usually administered in the clinic by a neurology specialist. This study evaluated the utility of home-based, self-administered digital endpoints in children with Friedreich's ataxia and unaffected controls and their relationship to standard clinical rating scales. In a cross-sectional study with 25 participants (13 with Friedreich's ataxia and 12 unaffected controls, aged 6-15 years), home-based digital endpoints that reflect activities of daily living were recorded over 1 week. Domains analyzed were hand motor function with a digitized drawing, automated analysis of speech with a recorded oral diadochokinesis test, and gait and balance with wearable sensors. Hand-drawing and speech tests were easy to conduct and generated high-quality data. The sensor-based gait and balance tests suffered from technical limitations in this study setup. Several parameters discriminated between groups or correlated strongly with modified Friedreich's Ataxia Rating Scale total score and activities of daily living total score in the Friedreich's ataxia group. Hand-drawing parameters also strongly correlated with standard 9-hole peg test scores. Deploying digital endpoints in home settings is feasible in this population, results in meaningful and robust data collection, and may allow for frequent sampling over longer periods of time to track disease progression. Care must be taken when training participants, and investigators should consider the complexity of the tasks and equipment used.

Sections du résumé

BACKGROUND
Friedreich's ataxia is an inherited, progressive, neurodegenerative disease that typically begins in childhood. Disease severity is commonly assessed with rating scales, such as the modified Friedreich's Ataxia Rating Scale, which are usually administered in the clinic by a neurology specialist.
OBJECTIVE
This study evaluated the utility of home-based, self-administered digital endpoints in children with Friedreich's ataxia and unaffected controls and their relationship to standard clinical rating scales.
METHODS
In a cross-sectional study with 25 participants (13 with Friedreich's ataxia and 12 unaffected controls, aged 6-15 years), home-based digital endpoints that reflect activities of daily living were recorded over 1 week. Domains analyzed were hand motor function with a digitized drawing, automated analysis of speech with a recorded oral diadochokinesis test, and gait and balance with wearable sensors.
RESULTS
Hand-drawing and speech tests were easy to conduct and generated high-quality data. The sensor-based gait and balance tests suffered from technical limitations in this study setup. Several parameters discriminated between groups or correlated strongly with modified Friedreich's Ataxia Rating Scale total score and activities of daily living total score in the Friedreich's ataxia group. Hand-drawing parameters also strongly correlated with standard 9-hole peg test scores.
INTERPRETATION
Deploying digital endpoints in home settings is feasible in this population, results in meaningful and robust data collection, and may allow for frequent sampling over longer periods of time to track disease progression. Care must be taken when training participants, and investigators should consider the complexity of the tasks and equipment used.

Identifiants

pubmed: 34355532
doi: 10.1002/acn3.51438
pmc: PMC8419399
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1845-1856

Subventions

Organisme : Novartis Pharma AG

Informations de copyright

© 2021 The Authors. Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association.

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Auteurs

Arne Mueller (A)

Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.

Elaine Paterson (E)

Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.

Avery McIntosh (A)

Novartis Development, Cambridge, Massachusetts, USA.

Jens Praestgaard (J)

Novartis Development, Cambridge, Massachusetts, USA.

Mary Bylo (M)

Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.

Holger Hoefling (H)

NIBR Informatics, Novartis Institute of Biomedical Research, Basel, Switzerland.

McKenzie Wells (M)

Division of Neurology, Departments of Neurology and Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.

David R Lynch (DR)

Division of Neurology, Departments of Neurology and Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.

Christian Rummey (C)

Clinical Data Science GmbH, Basel, Switzerland.

Michelle L Krishnan (ML)

Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.

Meredith Schultz (M)

Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.

C J Malanga (CJ)

Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.

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