Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT03886792
Eligibility Criteria:
Inclusion Criteria:
1. Age of 3 to 12 months with upper trunk brachial plexus birth palsy confirmed by an attending Hand and Upper Extremity Surgeon;
2. Full-term at birth;
3. A minimum score of '1' (0-7 scale) in elbow flexion of affected arm (isometric contraction) based on the Active Movement Scale (AMS);
4. Score ≥ 25th percentile on the motor subtest of the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSITD-III®);
5. Ability to sustain attention/arousal for a 10 minute training period based on criteria from the Neonatal Behavioral Assessment for an awake-alert state.
Exclusion Criteria:
1. Visual/auditory deficits;
2. Nerve repair/shoulder surgery;
3. Excessive crying during session(s);
4. Shoulder, elbow, or wrist joint contractures \> 20° in the affected arm;
5. An inability to trigger the musical-toy to play at baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Months
Study:
NCT03886792
Study Brief:
Protocol Section:
NCT03886792