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Scoliosis clinical trials

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NCT ID: NCT06224361 Not yet recruiting - Clinical trials for Scoliosis; Adolescence

Reliability of a New Balance Assessment System in Patients With Adolescent Idiopathic Scoliosis

Start date: January 30, 2024
Phase:
Study type: Observational

Postural stability is one of the most important factors that determine a person's ability to make and maintain movements. It has been reported that in the presence of scoliosis, the postural stability of people is negatively affected due to somatosensory disorders. There are many studies in the literature that evaluate the postural stability of cases diagnosed with scoliosis with objective methods. Evaluation of postural oscillations with objective devices is used to determine whether postural stability changes in AIS and whether the type and location of scoliosis affect the progression. The most commonly used objective devices for this purpose are balanced assessment systems in which changes in postural sway are recorded on the force platform. Our study aims to investigate the reliability of the "Postural Stability", "Limits of Stability", "Sensory Integration" and "Bilateral Comparison" tests of the Al Balance Balance Exercise and Analysis System in cases with Adolescent Idiopathic Scoliosis. After the demographic information of the cases that meet the inclusion criteria within the scope of the study is recorded, postural stability and balance evaluations within the Al Balance System will be performed on the cases. Evaluations will be carried out with bare feet and feet positioned at the same coordinates. The tests will last 30 seconds and the test will be repeated a total of 3 times with a 1-minute rest between tests. These measurements will be repeated after 7 days to evaluate reliability. With this study, the reliability of a new and local balance assessment system will be tested in cases with AIS.

NCT ID: NCT06217510 Not yet recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace. Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.

NCT ID: NCT06118814 Not yet recruiting - Body Image Clinical Trials

Investigation of Virtual Reality Supported Core Stabilization Exercises and Basic Body Awareness Therapy Activities in Individuals With Adolescent Idiopathic Scoliosis

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Scoliosis is a three-dimensional deformity of the trunk and spine, which can significantly worsen during advanced growth stages. While scoliotic deformities have various causes, approximately 80-90% of all scoliosis cases have an unknown origin and are referred to as idiopathic scoliosis. Adolescent Idiopathic Scoliosis (AIS) is the most common subtype of idiopathic scoliosis. The primary treatments for AIS include physiotherapy, bracing, and spinal surgery. Several scoliosis-specific exercise programs exist as part of physiotherapy interventions to treat scoliosis, with core stabilization being one of the methods aimed at maintaining spinal alignment. Virtual reality is an interactive, three-dimensional simulation model created by computers that provides participants with a sense of reality and enables mutual communication. Virtual reality offers a method to create stimulating and engaging environments, using task-oriented techniques to leverage individual interests and motivation. One of the most significant advantages observed in all forms of virtual rehabilitation is its ability to promote interactivity and patient motivation. In the literature, virtual reality applications have been used in healthcare to facilitate recovery, post-illness rehabilitation, and enhance performance in athletes. However, there is limited research on the application of virtual reality therapy for scoliosis patients. One study mentioned the use of two scoliosis-specific exercises through video-assisted games, but the limited exercise repertoire resulted in no significant differences. Other video-assisted studies have suggested that exercises targeting posture, balance, and walking can be utilized for scoliosis patients. Therefore, our study aims to apply core stabilization exercises to scoliosis patients using virtual reality applications and investigate their effects on patient improvement. While studies examining the effectiveness of core stabilization exercises on body awareness in adolescents with idiopathic scoliosis are limited, it has been reported that the basic body awareness therapy is effective in terms of pain, body image, quality of life, and functionality. Our study aims to contribute to the literature by utilizing the therapeutic effects of both basic body awareness and virtual reality-supported exercises. The research will be conducted at Ruhi Tingiz Physical Therapy and Rehabilitation Hospital, affiliated with Amasya University Training and Research Hospital. Participants diagnosed with adolescent idiopathic scoliosis will be randomly assigned to four groups for the study. All participants' curvature severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spinal pain, Cosmetic Defect Assessment-Walter Reed Visual Assessment Scale (The Walter Reed Visual Assessment Scale (WRVAS)), Quality of Life Assessment-"Scoliosis Research Society-22" (SRS-22), and Children's Depression Scale (ÇDÖ) will be evaluated before and after treatment.

NCT ID: NCT06096181 Not yet recruiting - Dexmedetomidine Clinical Trials

Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery

Start date: December 2023
Phase: Phase 2
Study type: Interventional

Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. The purpose of this study is to compare two combinations of total intravenous anesthetic medications in children with Adolescent Idiopathic Scoliosis having posterior spinal fusion surgery. Participants in the study will be randomly selected to receive either Propofol and Remifentanil or Propofol and Dexmedetomidine as their total intravenous anesthesia (TIVA). TIVA is favored over gas anesthesia because gas anesthesia can affect the neurological monitoring necessary for this surgery. The first combination (Propofol + Remifentanil) is the most common one used for this surgery at our institution, and the second combination (Propofol + Dexmedetomidine) is more commonly used in adult spine surgery. Though Dexmedetomidine is not approved for pediatric use by the FDA, it is widely used in pediatric patients for procedural sedation and surgical anesthesia in the US and worldwide. Both anesthetic combinations are used safely in adult and pediatric patients at our institution. Although remifentanil works fast and is an excellent pain medication during surgery, there are reports that it's use can cause increased pain sensitivity and greater need for narcotic pain medication after surgery. This phenomenon is known as opioid-induced hyperalgesia. The investigators hypothesize that avoiding the use of remifentanil in the TIVA by using dexmedetomidine could avoid OIH and thus result in superior postop pain control. Our study's primary goal is to measure the total opioid consumption on postoperative days (POD)# 0 and 1. Our secondary goals are to measure the pain scores on a visual analog scale (VAS) on POD# 0 and 1, measure the time it takes for participants to move their feet to command when surgery is done, and measure the time it takes for participants to be extubated when surgery is done. By comparing these measurements, the investigators hope to find out if there is any significant difference between the two TIVAs in terms of postop opioid requirements, pain scores, and time to wake up from anesthesia. The investigators hope that our study gives us more knowledge on how to better treat postoperative pain in children who have spine surgery to correct their

NCT ID: NCT06087510 Not yet recruiting - Dexmedetomidine Clinical Trials

Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes

Start date: January 2024
Phase: Phase 4
Study type: Interventional

Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe acute postoperative pain is one of the major risk factors of CPSP. Spinal correction surgery is associated with severe pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have antihyperalgesic effects and may reduce CPSP. Dexmedetomidine is an alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effect; it is frequently used as an adjuvant to postoperative analgesia. In a previous trial of 200 patients after scoliosis correction surgery, mini-dose esketamine-dexmedetomidine in combination with opioids significantly improved analgesia and sleep quality but did not reduce CPSP. The authors speculate that increasing esketamine dose in the combination may further improve analgesia and, therefore, reduce the occurrence of CPSP.

NCT ID: NCT06076577 Not yet recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Does a Pre-operative Exercise Program Improve Post-operative Outcomes for Fusion Patients

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

A study found that in 1744 patients undergoing fusion surgery for adolescent Idiopathic scoliosis, 12% had back pain remaining after recovering from surgery. Rehabilitation prior to spine surgery or prehabilitation (prehab), has been shown to reduce costs and improve functional outcomes in patients who have had total hip or total knee arthroplasties. There is a lack of literature looking at prehab in the context of spine surgeries. The purpose of this study is to see if prehab can improve patient outcomes such as decreased pain, decreased length of stay in the hospital, and improved functional outcomes in patients undergoing fusion surgery for adolescent idiopathic scoliosis.

NCT ID: NCT06067893 Not yet recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

Start date: May 2024
Phase: Phase 4
Study type: Interventional

This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.

NCT ID: NCT06062550 Not yet recruiting - Dexmedetomidine Clinical Trials

Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery

Start date: October 2023
Phase: Phase 4
Study type: Interventional

Scoliosis correction surgery is associated with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and drug tolerance. In a recent trial, mini-dose esketamine and dexmedetomidine combination as a supplement to sufentanil significantly improved analgesia and subjective sleep quality after spinal correction surgery without increasing adverse events; however, the proportion of patients with moderate-to-severe pain remained high. The authors speculate that increasing esketamine dose in the combination may further improve analgesic effects.

NCT ID: NCT06055140 Not yet recruiting - Pain Clinical Trials

Evaluation of Thoracolumbar Fascia and Relationship With Low Back Pain in Individuals With Idiopathic Scoliosis

Start date: October 1, 2023
Phase:
Study type: Observational

This observational study seeks to explore the potential association between thoracolumbar fascia characteristics and low back pain in individuals diagnosed with idiopathic scoliosis.

NCT ID: NCT06023043 Not yet recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

Start date: November 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: - What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? - Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: - Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years - Have clinical photos of their incision at 3 months, 1 year, and 2 years - Their photos will be assessed using the stony book scar evaluation scale - For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. - Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.