29 closest matches · ranked by relevance
Nonsynostotic Plagiocephaly
Primary: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months — 23; 3; 25; 45 Participants — p=0.01
Dolichocephaly
Primary: Feasibility and Safety — 7; 1 count
Plagiocephaly, Nonsynostotic
Primary: Change in Cranial Measurements as Measured by CVA — 11.6; 7.1 mm
Plagiocephaly
Primary: Safety of Use of the Premie Pouch in VLBW Infants — 0 participants
Preterm Infants · Dolichocephaly · Positional Scaphocephaly
Primary: Cranial Index (CI) — 79 cranial index
Nonsynostotic Plagiocephaly
Primary: Number of Participants With Qualitatively Determined Normalization of White Matter Pathways — 2 Participants
Craniosynostosis
Primary: Blood Flow and Perfusion — 26.8 ml/min/100g — p=0.004
To Determine Efficacy of the Headpod · Cerebral Palsy
Primary: Change in Head Holding Active Time From Baseline to 6 Months — 83.63 Seconds
Skull Fractures
Primary: Planarity of Bone Flap After Implantation — 23; 0; 2; 17 Participants
Stroke · Hemiparesis
Primary: Cortical Excitability MEP Amplitude (µV) — 325 µV
Down Syndrome
Primary: Step Width — 10.4 cm
Hypoxic-Ischemic Encephalopathy · Brain Injury · Neonatal Seizure
Primary: Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. — 28 Participants
Cerebral Palsy · Neuromuscular Scoliosis
Primary: Cobb Angle — 23.77; 26.31 degrees
Flat Foot · Pressure Ulcer
Primary: Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) — 17; 21 Participants
Skin Laxity · Lipodystrophy
Primary: Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale — 2 Participants
Arnold-Chiari Malformation, Type 1 · Chiari Malformation Type I · Type I Arnold-Chiari Malformation
Primary: The Number of Participants With Surgical Complications — 8; 10 Participants
Clubfoot
Primary: Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours) — 91.7; NA; NA; 86.8 percentage of time worn
Amyotrophic Lateral Sclerosis
Primary: The Amounts of Change of Landmarks Position According to Posture — 1.0; 2.4; 2.9; 5.6 mm
Premature Birth of Newborn
Primary: NICU Network Neurobehavioral Scale (NNNS) — 3.1; 2.56 Asymmetry Score (units on a scale)
Sleep Apnea, Obstructive · Hypotonia · Child, Only
Primary: Ability to Tolerate Measured by Percent of Participants With Protocol Goal — 50 percent of participants
Cervical Spine Injury
Primary: Cervical Spine Injury — 274; 159 Participants — p=.05
Isolated Clubfoot
Primary: Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs — 0.81; 0.65 survival probability — p=0.03
Sleep Disordered Breathing · Sleep Hypopnea · Sleep Apnea
Primary: Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement — 8 Participants — p=<.05
Osteoporosis · Cerebral Palsy · Spina Bifida
Primary: Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan — 0.043; -0.025 percent change
Platelet Aggregation, Spontaneous · Migraine With Aura · Patent Foramen Ovale
Primary: Change in Migraine Characteristics — 43; 2; 17 Participants
Genu Varum · Genu Valgum · Joint Diseases
Primary: Safety Measurement: Percentage of Subjects Who During the Observation Period Have at Least One Complication Certainly or Potentially Related to the Device in the Studio…
Displaced Forearm Fractures
Primary: Loss of Radius Fracture Reduction — 35; 35; 66; 66 participants — p=1.00
Platysma Prominence
Primary: Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) — 12.0…
Pressure Injury
Primary: Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI) — 13; 14 Participants