NCT02346825.

Trial name or title	The baby CHAMP study (Children With Hemiparesis Arm and Movement Project) (The Baby CHAMP)
Methods	Aim 1: to test the efficacy of 3 different constraint conditions used as part of administering a standardised form of therapy known as ACQUIRE. The 3 constraint conditions are: i) continuous constraint, ii) part‐time constraint, and iii) no constraint Aim 2: to monitor stress levels and safety risks related to use of constraint in the 3 conditions identified above (Aim 1) Design: randomised controlled trial
Participants	Inclusion criteria Child is 6 ‐ 24 months old Diagnosis of unilateral/asymmetrical CP Has functional upper extremity impairment levels of MACS II, III, or IV Parent(s) willing to be partners in study and participate in follow‐up assessments for 12 months Exclusion criteria Medical or sensory condition that prevents full therapy participation (e.g., frequent uncontrolled seizures, blindness) Received CIMT or had botulinum toxin therapy in past 6 months
Interventions	Intensive plus cast Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing a full‐arm cast on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained Intensive plus splint Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing a part‐time splint on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained Intensive no constraint Children in this group will have 3 hours of daily therapy each weekday for 4 weeks but will not wear a constraint. Parents will be required to do 45 minutes of daily therapy for which they will be trained
Outcomes	Primary outcomes Change in the Mini ‐ Assisting Hand Assessment (Time Frame: immediately prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment) Change in the Bayley Infant Scales of Development (Time Frame: immediately prior to treatment, immediately after treatment, 6 months after treatment, 12 months after treatment)
Starting date	January 2014
Contact information	Stephanie C DeLuca, 540‐526‐2098 stephdeluca@vt.edu Laura Bateman, 540‐526‐2033 laurapb2@vt.edu
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