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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07311018
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of spastic unilateral or bilateral cerebral palsy based on clinical and MRI findings.
* Involvement of the distal upper extremity (wrist and/or fingers).
* Aged between 6 and 15 years.
* No history of botulinum toxin injection or surgical intervention to the upper extremity within the past 6 months.
* Gross Motor Function Classification System (GMFCS) levels I-III.
* Manual Ability Classification System (MACS) levels I-III.
* Upper extremity spasticity corresponding to 0, 1, or 1+ on the Modified Ashworth Scale (MAS).
* Passive wrist extension limitation not exceeding 10 degrees.
* Ability to follow verbal instructions (mental level reported as "normal" or "mild mental retardation" in the medical record).
Exclusion Criteria:
* Currently participating in a specific hand rehabilitation program.
* Presence of visual or hearing impairment.
* History of epilepsy.
* Presence of chronic, orthopedic, or systemic conditions that may interfere with participation.
* GMFCS levels IV or V.
* MACS levels IV or V.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
15 Years
Study:
NCT07311018
Study Brief:
Protocol Section:
NCT07311018