Lacey
No evidence of any benefit from a course of hyperbaric oxygen for children with spastic cerebral palsy.
Clinical Bottom Line:
|
1. Hyperbaric oxygen did not improve gross motor function measures compared to a sham treatment. |
Citation/s:1. Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Annals of neurology. 2012 Nov 1;72(5):695-703
Lead author's name and fax: Daniel Lacey: laceyd@childrensdayton.org
Three-part Clinical Question:For children with spastic cerebral palsy, does the addition of a course of hyperbaric oxygen to standard therapy result in any improvement in gross motor function?
Search Terms: Cerebral Palsy; motor function; paediatrics
The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Children aged 3 to 8 years with spastic cerebral palsy
Control group (N = 24; 22 analysed): 14% oxygen breathing at 1.5 ATA for 80 minutes daily, Monday to Friday to a total of 40 sessions over 8 weeks.
Experimental group (N = 25; 24 analysed): As above but breathing 100% oxygen.
The Evidence:
Measure |
Sham Group |
HBO Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
|
Gross Motor Function Measure-88 (end of treatment) |
41.2 |
29.6 |
40.8 |
33.4 |
-0.4 |
-595 to 595 |
|
Pediatric Evaluation of Disability -self care category (end of treatment) |
49.5 |
15.2 |
52.1 |
20.5 |
2.6 |
-199 to 194 |
Comments:
1. 14% oxygen breathing at 1.5 ATA was to achieve the same PIO2 as breathing air at 1 ATA.
2. Sample size calculation suggested 42 patients in each group was required to find a 5% improvement in the HBO group versus the sham group. The trial was stopped early for futility on a planned interim analysis. Six month follow-up did not suggest a different outcome.
3. Patients randomised in permuted blocks of various sizes with allocation concealment and not likely subject to bias.
4. GMFM-88 has been validated in this group. PEDI scores improved statistically significantly but not to a clinically important extent in both groups, but did not differ between groups and this seemed to persist through to the six month follow-up on. Authors suggest this is a participation effect.
5. About one third of children experienced ear pain during the course of treatment and two required withdrawal of treatment (one in each group).
Appraised by:Mike Bennett POWH m.bennett@unsw.edu.au; Saturday, 25 September 2021
Kill or Update By: September 2026
