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Tests treatment safety and results for Cerebral Palsy (CP)
Official title Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT07539389
What this study is testing
- What it's testing
- Cerebral palsy (CP) is a common cause of gait impairment in children, leading to limitations in mobility and daily activities. Although conventional physical therapy is widely used, it has limitations in delivering consistent and intensive training.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 10
You may be able to join if
- people eligible for participation in this clinical investigation shall meet all of the following criteria.
- Patient diagnosed with Cerebral Palsy
- Age from 2 to 10 years old
- Classified as Levels II to IV according to GMFCS
- Manual Muscle Testing, MMT score of 0 to 4
You likely can't join if
- people meeting any of the following criteria are not eligible for participation in the clinical investigation.
- people who do not meet the criteria of age, height, weight, body dimensions, or joint range of motion
- people with skin lesions, pressure sores, infections, or other conditions at area where device touches and makes difficult to use device
- Classified as Levels V according to GMFCS
- people with severe spasticity (MAS \> 3), or those at risk of significant worsening of spasticity after training.
- people unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension)
See the full eligibility criteria
- people eligible for participation in this clinical investigation shall meet all of the following criteria.
- Patient diagnosed with Cerebral Palsy
- Age from 2 to 10 years old
- Classified as Levels II to IV according to GMFCS
- Manual Muscle Testing, MMT score of 0 to 4
- Modified Ashworth Scale, MAS score of 3 and under
- people with sufficient cognitive function to comply with study procedures
- people with adequate upper limb function required for device use and study procedures
- people who meet the physical requirements for use of the medical device as defined by the manufacturer
- people meeting any of the following criteria are not eligible for participation in the clinical investigation.
- people who do not meet the criteria of age, height, weight, body dimensions, or joint range of motion
- people with skin lesions, pressure sores, infections, or other conditions at area where device touches and makes difficult to use device
- Classified as Levels V according to GMFCS
- people with severe spasticity (MAS \> 3), or those at risk of significant worsening of spasticity after training.
- people unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension)
- people with significant cardiovascular disease or a history of myocardial infarction within the past 6 months
- people with medical conditions that are contraindications for use of the medical device as defined by the manufacturer.
- people for whom weight-bearing, standing, or gait training is medically contraindicated (e.g., fractures, severe osteoporosis, severe joint deformity, or joint instability)
- people who have received treatments affecting muscle tone within the past 4 months, such as botulinum toxin injections or baclofen pump implantation
- people who experience adverse events or undesirable side effects during the clinical investigation that make continued participation difficult
- people whom the investigator judges to be unsuitable for participation or continuation in the clinical investigation.
The study team makes the final eligibility decision.
Where it's taking place
- Songpa, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 10 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Songpa, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.