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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT06963151
Eligibility Criteria:
Inclusion Criteria:
1. Child with unilateral CP confirmed by a physician
2. Child aged between 3 years and 5 years 11 months (corrected age) at study entry
3. Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.
4. Ability to understand instructions and complete all assessments.
5. Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.
6. Written informed consent obtained from a parent or legal guardian.
7. Commitment to having the same parent or guardian participate throughout the study.
Exclusion Criteria:
1. Diagnosis of ataxic CP.
2. Uncontrolled epilepsy.
3. History of botulinum toxin injection or surgery within 6 months of study entry or scheduled within 3 months of the intervention (ie, during the study period).
4. Visual or auditory deficits that could interfere with participation in the study.
5. Significant cognitive or behavioural disorder limiting the ability to follow instructions, as reported in discussions with the family, therapists and/or during a prior assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
5 Years
Study:
NCT06963151
Study Brief:
Protocol Section:
NCT06963151