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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT07146932
Eligibility Criteria:
Inclusion Criteria:
* Between the age of 5 and 14 years and diagnosed with cerebral palsy;
* have joint range of motion within normal functional limits for ambulation as determined by study staff;
* Be able and willing to comply with study procedures, including follow-up requirements;
* Patient cognitive status and ability to communicate must be at a level consistent with that required to participate in standard motor rehabilitation;
* can follow directions as determined by study staff;
* be able to physically fit into exoskeleton device; height from 110 to 160 cm (43 to 62 inches) and weighing up less than 65 kg (145 lbs);
* be able to walk 10 meters with the aid of a walking assistive device and/or a single human assistant;
* bilateral lower limb spasticity that allows lower limb range of motion within the device.
Exclusion Criteria:
* any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
* skin issues that would prevent wearing the device;
* pre-existing condition that caused exercise intolerance;
* uncontrolled seizure disorder, spasticity or joint contracture that would interfere with walking;
* neuromuscular, neurological, cardiovascular or orthopedic pathologies that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs;
* severe spasticity (Modified Ashworth Scale = or \> 3);
* hip extension range of motion \< 0 degrees, knee flexion contracture \> 20 degrees, knee valgus \> 40 degrees, 2 or more fractures within the past year, hip subluxation (\> 40% migration),
* existing Baclofen pump, and/or Botox injections within the past 4 months of study enrollment;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
14 Years
Study:
NCT07146932
Study Brief:
Protocol Section:
NCT07146932