N/A
Completed N=18
A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Source: ClinicalTrials.gov NCT00895154 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Full Scale IQ (FSIQ) (WASI) — 86.43; 88.0 scores on a scale
Summary
The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full Scale IQ (FSIQ) (WASI) |
86.43; 88.0 | — |
| PRIMARY Verbal IQ (PIQ) (WASI) |
87.86; 87.78 | — |
| PRIMARY Performance IQ (PIQ) (WASI) |
87.29; 90.44 | — |
| PRIMARY Letter Word Identification T Score (WJ-III) |
42.14; 44.00 | — |
| PRIMARY Reading Fluency T Score (WJ-III) |
40.14; 40.44 | — |
| PRIMARY Calculations T Score (WJ-III) |
36.86; 44.56 | — |
| PRIMARY Math Fluency T Score (WJ-III) |
34.29; 38.56 | — |
| PRIMARY Spelling T Score (WJ-III) |
43.29; 44.22 | — |
| PRIMARY California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score |
42.14; 36.90 | — |
| PRIMARY CVLT-C Trials 1-5 Semantic Clustering T Score |
50.71; 43.70 | — |
| PRIMARY CVLT-C Trials 1-5 Short Delay Recall T Score |
39.29; 34.50 | — |
| PRIMARY CVLT-C Trials 1-5 Long Delay Recall T Score |
40.00; 36.40 | — |
| PRIMARY CVLT-C Trials 1-5 Recognition Discriminability T Score |
42.86; 37.50 | — |
| PRIMARY Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score |
33.67; 37.00 | — |
Eligibility Criteria
Inclusion Criteria
- Sickle cell disease that is confirmed by hemoglobin analysis
- Has a brain magnetic resonance imaging (MRI) document reading by a neuroradiologist
- Cognitive deficits, which are defined by one standard deviation lower than the normal ranges of an age-based standard score in cognitive tests that are evaluated by a psychologist
- Must be a student who will remain in school for at least 2 years
- Must provide informed consent with assent in accordance with the institutional policies (institutional review board approval)
Exclusion Criteria
- Known developmental delays (these participants are ineligible because their learning potential may be biased from a prior insult)
- Intelligent quotient is less than 50 (may have impaired learning potential)
- Aphasic (i.e., unable to produce intelligible speech)
Data sourced from ClinicalTrials.gov (NCT00895154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.