Home Monitoring of Adult Patients With SMA: a Pilot Multicenter Validation Study

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 15, 2023

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2024

Conditions
Muscular Atrophy, Spinal, Type IIMuscular Atrophy, Spinal, Type III
Interventions
OTHER

Strength force measurment

The grip and pinch strength of the patient will be evaluate using dedicated devices (MyoGrip and MyoPinch)

OTHER

Time tests

Lower and upper limb capacities of the patients will be measured during timed tests

OTHER

Motor scales

Patient's motor functional abilities will be evaluated using specific motor scales (MFM32, RULM)

OTHER

Questionnaires

Patients and caregivers quality of life will be measured with different questionnaires (SMA-FRS, QOL-gNMD, SMAIS, PREM)

DEVICE

Accelerometry

Patients physical activity will be measured at home using accelerometer sensors

OTHER

MNR

Sub-group of patients will perform an NMR imaging to evaluate the intramuscular fatty infiltration in thighs and muscle volume in thighs

OTHER

Bio-impedance analysis

The patients' muscular and fatty volume will be evaluated using BIA technic (compared to MNR)

Trial Locations (6)

37044

CHRU de Tours, Tours

44093

CHU de Nantes, Nantes

49933

CHU d'Angers, Angers

51092

CHU de Reims, Reims

59000

CHU de Lille, Lille

75013

Institute of Myology, Paris

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Institut de Myologie, France

OTHER

NCT05839145 - Home Monitoring of Adult Patients With SMA: a Pilot Multicenter Validation Study | Biotech Hunter | Biotech Hunter