Does the use of home-based assistive rehabilitation technology enhance the functional benefits of botulinum toxin in children with cerebral palsy who have upper limb movement difficulties: a single-blind randomised controlled trial.

Background. Spastic cerebral palsy is a common cause of childhood activity limitation that restricts children’s personal development. Botulinum toxin is a spasticity treatment that can improve upper limb activity limitation when combined with rehabilitation therapy. We investigated whether use of a computer-assisted arm rehabilitation (CAAR) device enhanced the benefits of botulinum toxin treatment of the upper limb of children with cerebral palsy.

Method. Fifteen children with cerebral palsy aged 5 – 12 years old undergoing botulinum toxin treatment for spasticity of the upper limb were randomly allocated into a CAAR group and a control group using minimisation, a procedure that balances groups for prognostic factors e.g. age and disability. Children used CAAR at home for 6 weeks. Assessments were carried out by blinded assessor at baseline, six and twelve weeks.

Primary outcome measure. ABILHAND-kids.
Secondary outcome measure. Canadian Occupational Performance Measure (COPM).

Results.
ABILHAND-kids. Activity limitation worsened following botulinum toxin treatment. An ANCOVA revealed that this was not significant (median scores, all participants: baseline, 0.8084; six weeks, 0.145; twelve weeks, 0.334; p=0.462) and that there was no difference between groups (p=0.699).
COPM. A Friedman’s ANOVA revealed a statistically significant improvement that was clinically non-significant (baseline score, 4/10; six week score, 4.6/10; twelve week score, 4.6/10; p=0.031). A Kruskal-Wallis ANOVA revealed no difference in scores between groups at each time point.
CAAR use. Mean daily use, 7 minutes. Maximum use, 256 minutes (played over 24 days, mean daily use 10.667 minutes).
Sample size. This sample size was underpowered by 75%.

Conclusion. This study potentially supports evidence that botulinum treatment should be used only in combination with rehabilitation therapy but it was not adequately powered and a Type II error cannot be ruled out. The CAAR device did not engage the children enough to promote sufficient intensity and repetition of arm movements.