Investigating rehabilitation by activities involving the trunk to improve balance and gait control in young children with cerebral palsy: A randomized open-label crossover trial protocol.

Prior research demonstrated that RAIT for 3 months significantly improved trunk control while standing and early trunk deceleration and coupled negative ankle power in children with CP aged 5-12 years.

• RAIT is based on activities in intermediate postures
• Duration of prior intervention was 3 months
• Age group studied previously was 5-12 years
• Outcomes included trunk control while standing and early trunk deceleration and coupled negative ankle power due to plantar flexors while walking autonomously

The trial protocol targets children with CP aged 18 months to 5 years and 6 months, investigating RAIT over a longer time period than prior studies.

• Age range is 18 months to 5 years and 6 months, younger than the previously studied cohort of 5-12 years
• The adapted design investigates effects for longer than 3 months
• The rationale is that motor disorders develop early, warranting investigation in younger children
• The trial is registered at ClinicalTrials.gov: NCT06438432
• The study uses a randomized open-label crossover design

The protocol hypothesizes at least a 30% reduction in initial motor disorders after RAIT compared to usual rehabilitation, with progressive improvements of 40% and 50% at 6 and 12 months respectively.

• Expected reduction at initial assessment: at least 30%
• Expected reduction at 6 months: 40%
• Expected reduction at 12 months: 50%
• These estimates reflect 'cumulative training effects'
• Projections are based on prior findings in older children with CP

The primary outcome measure is excessive early anterior deceleration of the sternum during gait, measured by inertial measurement unit.

• Measured using an inertial measurement unit
• The outcome specifically targets early anterior deceleration of the sternum
• This measure is considered to reflect trunk balance and control
• It is expected to be reduced after RAIT

Secondary gait outcomes include excessive anterior location of center of pressure on affected leg(s), Enhanced Gait Variability Index, and step width, measured by a walkway equipped with pressure sensors.

• Measurement tool is a walkway equipped with pressure sensors
• Outcomes include anterior location of center of pressure on affected leg(s)
• Enhanced Gait Variability Index is included as a secondary outcome
• Step width is also measured as a secondary outcome
• All variables are expected to be influenced by trunk balance and control

Gross motor, balance, and trunk function are assessed using the item set version of the Gross Motor Function Measurement 66 and the Early Clinical Assessment of Balance.

• The Gross Motor Function Measurement 66 item set version is used
• The Early Clinical Assessment of Balance is also employed
• These tools measure altered gross motor, balance, and trunk function
• These functional outcomes are expected to improve following RAIT