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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03677193
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of Cerebral Palsy.
2. Age: 8-18 years. This age range was selected given the popularity of video games and the size of the muscle sensors available.
3. Manual Abilities Classification System levels I-III.
4. Have a goal relating to improving hand / wrist function.
5. Dominantly spastic presentation
6. Able to co-operate, understand, and follow simple instructions for game play. This will be assessed during the information and assent process by the researcher.
7. Having passive ROM of at least 10° greater than AROM.
Exclusion Criteria:
1. History of unmanaged epilepsy. Video game systems are not recommended for individuals with a history of epilepsy as per manufacturer's Health and Safety Precautions.
2. Has received a Botulinum Toxin treatment within 3 months or constraint-based movement therapy within 6 months of the study enrollment.
3. Visual, cognitive or auditory disability at a level that would interfere with game play. The child must have normal or corrected to normal vision and hearing.
4. Dominantly dystonic presentation
5. Unable to commit an estimated minimum of 10 hours to their training plan over four weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT03677193
Study Brief:
Protocol Section:
NCT03677193