Status:
NOT_YET_RECRUITING
Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
Lead Sponsor:
COSMO ROBOTICS CO., Ltd
Collaborating Sponsors:
Kessler Foundation
Conditions:
Cerebral Palsy (CP)
Eligibility:
All Genders
5-14 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP). ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07146932
Start Date
October 1 2025
End Date
January 1 2026
Last Update
September 22 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052