Study: NCT06629324

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Autologous Bone Marrow Mononuclear Cell Transfusion
Description: Bone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Autologous Bone Marrow Mononuclear Cell Transfusion
Description: Bone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Rehabilitation
Description: Rehabilitation methods involve various therapies tailored to the patient\&#39;s mobility level. (1) Physical therapy focuses on exercises to control the head, neck, and trunk, manage muscle tone, and reduce spasticity. Patients gradually practice essential movements like rolling, sitting, crawling, standing, and walking, aligned with developmental milestones. (2) Occupational therapy aims to enhance fine motor skills and daily activities. Through hand function exercises, patients improve upper limb functionality, strengthen their ability to grasp and hold objects and refine coordination between both hands and hand-eye coordination. (3) Speech therapy improves communication, cognitive abilities, and chewing and swallowing functions. Specific exercises target lip and mouth movements, helping patients express and understand language better. Additionally, there are activities to strengthen jaw and facial muscles, which are essential for improving chewing and swallowing abilities.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Rehabilitation
Description: Rehabilitation methods involve various therapies tailored to the patient\&#39;s mobility level. (1) Physical therapy focuses on exercises to control the head, neck, and trunk, manage muscle tone, and reduce spasticity. Patients gradually practice essential movements like rolling, sitting, crawling, standing, and walking, aligned with developmental milestones. (2) Occupational therapy aims to enhance fine motor skills and daily activities. Through hand function exercises, patients improve upper limb functionality, strengthen their ability to grasp and hold objects and refine coordination between both hands and hand-eye coordination. (3) Speech therapy improves communication, cognitive abilities, and chewing and swallowing functions. Specific exercises target lip and mouth movements, helping patients express and understand language better. Additionally, there are activities to strengthen jaw and facial muscles, which are essential for improving chewing and swallowing abilities.