Trial · NCT01147653
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Gross Motor Function Measure 66 (GMFM-66) Score | Baseline to Year 1 | All enrolled patients were analyzed as randomized from Baseline to Year 1. | units on a scale | MEAN |
| SECONDARY | Change in Peabody Gross Motor Quotient From Baseline to Year 1 | Baseline to Year 1 | Participants outside of the applicable age range for the PDMS-2 at Baseline or Year 1 were excluded from the analysis. | units on a scale | MEDIAN |
| SECONDARY | Change in IT-QOL Questionnaire Score | Baseline to Year 1 | The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points. | units on a scale | MEDIAN |
| SECONDARY | Change in CP-QOL Score | Baseline, Year 1 | The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points. | units on a scale | MEDIAN |
| SECONDARY | Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI) | Baseline to Year 1 | Patients without substantial morphologic brain abnormalities that prevented accurate anatomical image parcellation. | Number of connections x10e5 | MEDIAN |
| SECONDARY | Change in Loes Score of Functional MRI From Baseline to Year 1 and From Year 1 to Year 2 | Baseline, Year 1, Year 2 | No data was available. | ||
| SECONDARY | Change in Bayley Scales of Infant and Toddler Development-III, Cognitive Composite From Baseline to Year 1 | Baseline to Year 1 | The Bayley III is an age-specific test and was used for 42 patients at Baseline. A total of 27 of these patients were also scored with the Bayley III at Year 1. The results here represent change from Baseline to Year 1 in the 27 participants assessed with the Bayley III at both time points. | units on a scale | MEAN |
| SECONDARY | Change in Wechsler Preschool and Primary Scale of Intelligence (WPPSI) III Full Scale Intelligence Quotient (IQ) for Younger Children (Ages 2 Years & 6 Months to 3 Years & 11 Months) From Baseline to Year 1. | Baseline to Year 1 | Change scores were evaluable in only 2 subjects who were assessed with the WPPSI-III at both Baseline and Year 1. One subject was randomized to Autologous Cord Blood and the other to Placebo. | units on a scale | NUMBER |
| SECONDARY | Change in the Wechsler Intelligence Scale for Children (WISC-IV) From Baseline to Year 1. | Baseline to Year 1 | Only one patient in this trial was evaluated with the WISC-IV and thus change over time could not be evaluated using this outcome measure. The single value for this patient is reported here. | Full Scale IQ Points | NUMBER |
| SECONDARY | Change in Cognitive Z-Score From Baseline to Year 1 | Baseline to Year 1 | When using all available cognitive assessments, the change in cognitive Z-score was available for 42 of the 63 participants. | Z scores | MEAN |
| SECONDARY | Change in Assisting Hand Assessment (AHA) Score From Baseline to Year 1 | Baseline to Year 1 | Participants who were less than 18 months old, or had diplegia or quadriplegia were excluded. For those with unspecified typography, AHA scores were excluded if scores on either the Modified Ashworth Scale or Barry-Albright Dystonia scale indicated neither or both of the upper extremities were involved. | units on a scale | MEAN |
| SECONDARY | Change in Pediatric Evaluation of Disability (PEDI) Self Care Score | Baseline to Year 1 | Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1. | units on a scale | MEAN |
| SECONDARY | Change in Pediatric Evaluation of Disability (PEDI) Mobility Score | Baseline to Year 1 | Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1. | units on a scale | MEDIAN |
| SECONDARY | Change in Pediatric Evaluation of Disability (PEDI) Social Function Score | Baseline to Year 1 | Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1. | units on a scale | MEAN |
| SECONDARY | Change in Child Behavior Checklist (CBCL) Z-score Internalizing Problems From Baseline to Year 1 | Baseline to Year 1 | Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age. | units on a scale | MEDIAN |
| SECONDARY | Change in Child Behavior Checklist (CBCL) Z-score Externalizing Problems From Baseline to Year 1 | Baseline to Year 1 | Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age. | units on a scale | MEAN |
| SECONDARY | Change in Child Behavior Checklist (CBCL) Z-score Total Problems From Baseline to Year 1 | Baseline to Year 1 | Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age. | units on a scale | MEDIAN |
| SECONDARY | Change in Parental Distress From Baseline to Year 1 | Baseline to Year 1 | No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit. | Change in percentile score | MEAN |
| SECONDARY | Change in Parent-Child Dysfunctional Interaction From Baseline to Year 1 | Baseline to Year 1 | No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit. | units on a scale | MEDIAN |
| SECONDARY | Change in Difficult Child Score From Baseline to Year 1 | Baseline to Year 1 | No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit. | units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01147653/outcomes