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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT07289360
Eligibility Criteria:
Inclusion Criteria: Diagnosis of hemiplegic CP; (2) MACS levels I (handles objects easily) to III (handles objects with difficulty). Note the MACS assesses overall ability to handle everyday objects, not the function of each hand.41 As such, a child who successfully accomplishes tasks one-handed would be categorized as MACS Level I, but may still benefit from targeted training with the hemiplegic limb. (3) aged 6 to 17 years with sufficient cognitive capacity and cooperation to play Bootle Blast and complete outcome assessments, (4) ability to communicate in English, (5) Able to travel to Holland Bloorview, Grandview or CHEO and complete a total of 3 in-person study appointments, (6) has a large screen (e.g. TV) with an appropriate play space (3m x 3m) in front, (7) at least intermittent access to the internet; (8) Have time to play Bootle Blast for 15-20 minutes/day, 3-4 days/week for 12 weeks. Of note, Bootle Blast was designed to enhance use of the hemiplegic limb in unilateral and bilateral activities. It has been used successfully with children with hemiplegic CP ranging in age from 6 to 17 and MACS levels I-III.
Exclusion Criteria: (1) received upper limb surgery, botulin toxin injections in the past 4 months, or constraint therapy/casting in the previous 3 months that may be associated with changing abilities, (2) currently or anticipates receiving active treatments impacting upper limb function during the study period, (3) uncontrolled epilepsy that may be triggered by video game play, (4) medical condition impeding safe participation in physical activity associated with Bootle Blast, and (5) visual limitations that interfere with Bootle Blast play.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT07289360
Study Brief:
Protocol Section:
NCT07289360