Effect Of Botulinum Toxin-A Therapy On Health-Related Quality Of Life In Children With Spastic Cerebral Palsy

ObjectiveTo analyze the effect of lower limb botulinum toxin-A therapy on health-related quality of life in children with diplegic spastic cerebral palsy.Method65 spastic cerebral palsy children aged 2 years 0 month-9 years 6 months were randomly divided into BTX-A treatment and control groups, 33 cases and 32 cases, respectively. All children were given systematic rehabilitation therapy for 6 months, and children in treatment group were injected with BTX-A at baseline. HRQOL was assessed at baseline, and 1, 3 and 6 months post-injection by completion of Pediatric Quality of Life( PedsQL) 4.0 Generic Core Scales and PedsQL 3.0 CP Module. Observe changes in PedsQL scores between two groups, variation trends of PedsQL scores over time, and concordance between child self-report and parent proxy-report scores. Results1. No statistically significant difference(P>0.05) between treatment and control groups was observed for any domain and total scores of PedsQL.2. Statistically significant changes(P<0.001) over time were observed for the PedsQL 4.0 Generic Core Scale Self-Report Physical and total Scores, and Proxy-Report Physical Scores. The trends of improvement of Physical Scores in treatment group were more significant than control group.3. Statistically significant changes(P<0.05) over time were observed for the PedsQL CP Module Parent Proxy-Report Daily Activities, School, Movement and Balance, Pain and Hurt and total scores, and the PedsQL CP Module Child Self-Report Daily Activities, Movement and Balance, Pain and Hurt, Fatigue and total Scores. The trends of improvement of Daily Activities, Movement and Balance, Pain and Hurt Scores in treatment group were more significant than control group.4. Intraclass concordance was excellent for the PedsQL Generic Core Physical Scale and the PedsQL CP Module Daily Activities Score, and good for the PedsQL CP Module School, Movement and Balance and Eating Scores, and moderate for Pain and Hurt, Fatigue and Speech Scores, but bad for the PedsQL Generic Core Psychological Scale.(P<0.001).Conclusions1. The systematic rehabilitation therapy improved the HRQOL of children with diplegic spastic CP, and the tendency of improvement was more significant after BTX-A adjunctive therapy.2. Lower limb BTX-A adjunctive therapy made a tendency of improvement in physical function of children with diplegic spastic CP, but had no significant effect on psychological function.3. Lower limb BTX-A adjunctive therapy made a tendency of improvement in daily activities, movement and pain of children with diplegic spastic CP, but had no significant effect on school activities, fatigue, eating and speech.4. There was good concordance between child self-report and parent proxy-report scores in any domains except psychological domain, so we should pay more attention to the completion of child self-report scales because the misunderstanding of parents.5. Multicentre study across the broader CP population is needed to popularize PedsQL 4.0 Generic Core Scales and PedsQL 3.0 CP Module, for they are excellent instruments for assessing HRQOL of children with CP.