BridgeMD
New treatment option for Adolescent Idiopathic Scoliosis (AIS)
Official title Support System Design for Adolescent Scoliosis Orthosis Wear
ClinicalTrials.gov ID: NCT07574229
What this study is testing
- What it's testing
- This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated "Product System" designed to transform the bracing experience from a burdensome task into a guided, supportive journey.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- Eligibility Criteria
- Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- Current orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).
- Between 10 and 18 years of age at the time of enrollment.
- Ability to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.
You likely can't join if
- Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).
- Scheduled spinal surgery within the planned study period.
- Severe skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.
- Previous participation in similar digital intervention studies for scoliosis management.
- Diagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.
See the full eligibility criteria
- Eligibility Criteria
- Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).
- Current orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).
- Between 10 and 18 years of age at the time of enrollment.
- Ability to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.
- Access to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal.
- Willingness of the participant to provide assent and the legal guardian to provide written informed consent.
- Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).
- Scheduled spinal surgery within the planned study period.
- Severe skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.
- Previous participation in similar digital intervention studies for scoliosis management.
- Diagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.