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Konectom NMD Application · DigiNOA

A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders

Ensayo de BIOGEN INC. en Atrofia muscular espinal.

Más ensayos de: Atrofia muscular espinal.

Fase

Sin fase asignada

Estado

Completado

Participantes

93

previstos

Centros

5

Fin del objetivo primario

jul 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2022.

Qué mide

Tipo de correlacion de los DOA de Konectom frente a la puntuacion total de la Escala Motora Funcional de Hammersmith Ampliada (HFMSE) en PwSMA (hasta 28 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments. The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; to evaluate group differences in smartphone-based Konectom DOAs \[self-administered at home and in-clinic\] between person with spinal muscular atrophy (PwSMA) and healthy subjects (HS); to evaluate the variability of Konectom DOAs self-administered in everyday environment in HS and PwSMA; to compare Konectom DOAs between in-clinic supervised administration versus self-assessments in everyday environment in HS, PwSMA groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes (PROs) in PwSMA and to evaluate the clinical safety of Konectom in PwSMA.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05109637), actualizada en feb 2024.