oSATCo App Development:
Data Collection

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Study Protocol

Data Collection Procedure

Data Collection Results

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Objectives

Data was collected for the purpose of:

SATCo

Cross sectional study
- Objective: train neural network on a wide range of children
Longitudinal study
- Objective: check repeatability and reliability of oSATCo results

Functional assessments

Objective: compare outcomes from SATCo and functional assessments

Project objectives:

1. Acquisition of a substantial cross-sectional dataset demonstrating the range of problems of trunk control in children with CP.
2. Acquisition of a cross-sectional dataset demonstrating a sample of problems of trunk control in children with SMA1.
3. Acquisition of a longitudinal dataset of children quantifying trunk control status to provide sufficient data to plan appropriately powered clinical trials using the tool.
4.Acquisition of an exploratory cross-sectional dataset defining the range of problems of trunk control in children with neuromuscular disorders including congenital myopathy, congenital muscular dystrophy, SMA type 2 and Duchennemuscular dystrophy to aid understanding of the natural progression of these conditions and enhance management.

Eligibility criteria

Inclusion criteria

Children with
- clinical diagnosis of CP, 2-16 years old.
- genetically confirmed SMA1 diagnosis, 3 months-16 years old.
- genetically confirmed diagnosis of NMD, 2-16 years old
Parents/guardians with capacity to give consent.

Exclusion criteria

SMA1 children who are on mechanical ventilation ≥16 hours per day or deemed clinically unfit to participate.
Both parents/guardians do not have sufficient understanding of English to give consent.
Children who pose a physical risk to themselves or the research team.

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Patient Identification, Recruitment, and Consent

Participant identification by:

CP: Community paediatric physiotherapists
SMA and NMD: Neuromuscular consultants and physiotherapists.

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Parent/Guardian contact with:

Letter of invitation sent by the care team
Information packs given in routine clinical appointment

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Once parent/guardian demonstrated interested:

Data collection date and room arrangement between parent/guardian, care team, and data collection team
Informed Consent signed before data collection

Baseline Data

We collected the following baseline data from the participants:

Age
Body height or length
Body weight
Medical record
- Main diagnosis
- Relevant medical history
- Classification, for CP: GMFCS and clinical type
SATCo
Functional assessment
- CP
  - GMFM-Research Item Set (carried out by research team on site)
- SMA
  - SMA Reach (provided by clinical staff from sites)
- NMD
  - CHOP-INTEND, NSAA, etc (provided by clinical staff from sites)

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What was involved in the data collection process?

Location
- hospitals, clinics, schools, community centers, MMU
Travel
- rental cars, trains, and taxi
Equipment set up
- duration 30 mins
- mobile set up: laptop, camera, tripods, bench, harnesses, toys
- no markers are attached to the child
SATCo
- duration 10-50 mins
Functional assessment
- CP only: GMFM, duration 10-30 mins