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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05403567
Eligibility Criteria:
Participants: Children and parent dyads living anywhere in the country can participate in this phase. Dyads will be screened to participate in the pre-intervention interview according to the following criteria:
Inclusion Criteria:
* Diagnosis of hemiplegic CP.
* 7 to 17 years of age: This age range was selected given the popularity of video games for children at this stage. This age group in CP has been studied successfully in previous research focused on active video game play, showing potential for change across their motor outcomes8-10.
* Motor impairment of the upper limb: difficulty to manipulate objects and/or perform activities of daily living with one hand/arm in alignment with the Manual Classification System levels I-III18, as reported by the parent and assessed via telephone by the clinician-researcher (DC - Appendix B, telephone screening). These children would require minimal assistance in playing the video game in the home environment.
* Having a primary family caregiver willing to participate.
* Resident of Costa Rica.
* Child and parent are able to understand and communicate verbally in Spanish or English.
* Child and/or parent are able to read and write.
* Child and/or parent has knowledge on how to use email and receive a video call or have a support person willing to assist them during the clinical assessment processes.
* Child and/or parent has access to a cellphone or computer at home.
* Ability to cooperate, understand, and follow simple instructions for game play as reported by parent.
* Having a TV screen (or similar) at home.
* Having an accessibility barrier that currently limits their access to upper limb rehabilitation services. These barriers include but are not limited to: the family is unable to pay for therapy, services are not available in their living area, or there is a lack of adapted transportation for the child to travel to a therapy center, as reported by the caregiver.
Exclusion Criteria:
* Receiving hand and arm therapy at the time of intervention.
* History of uncontrolled epilepsy. If the child has a history of epilepsy, they will require a note from a doctor indicating it would be safe to play video games as required in this study. A note will not be required if the child currently engages in at least 30 minutes of screen time a day on 2 or more days in a week as documented by a primary caregiver.
* Visual or hearing impairments that limit the ability to play the video game.
* Has received constraint induced movement therapy in the past 6 months, or botulinum toxin injections, or active therapy of the upper extremity within three months of the study enrollment.
* History of upper limb injury or disability that would make light exercise unsafe as reported by the caregiver.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT05403567
Study Brief:
Protocol Section:
NCT05403567