Effects of botulinum toxin A and/or bimanual task-oriented therapy on upper extremity activities in unilateral Cerebral Palsy: a clinical trial.
BACKGROUND
This study reports on the effects of botulinum toxin A (BoNT-A) injections in the upper extremity (UE) in children with unilateral Cerebral Palsy (uCP) combined with bimanual task-oriented therapy (BITT) or either treatment modality performed separately. Bimanual activities were measured with the Assisting Hand Assessment (AHA), the ABILHand-Kids questionnaire (AK), the Observational Skills Assessment Score (OSAS). Goal achievement was measured with Goal Attainment Scaling (GAS), using blind video assessment, and the Canadian Occupational Performance Measure (COPM).


METHODS
Thirty-five children, mean age 7.14 years (SD 2.63), 11 Manual Ability Classification Score (MACS) I, 15 MACS II and 9 MACS III, participated. The trial started with four study groups: BoNT-A-only (n = 5), BITT-only (n = 11), BoNT-A + BITT (n = 13), and control (n = 6). Twenty-two children were randomised, 13 children received their parents' preferred treatment: BoNT-A + BITT or BITT-only. Three comparisons were analysed: BITT (BoNT-A + BITT and BITT-only; n = 24) versus no BITT (BoNT-A-only and control; n = 11), BoNT-A (BoNT-A-only and BoNT-A + BITT; n = 18) versus no BoNT-A (BITT-only and control; n = 17), and the additional effect of BoNT-A (BoNT-A + BITT versus BITT-only). Follow-up time: 24 weeks.


RESULTS
No significant differences between the groups were found on the AHA. The amount of use of both hands on the OSAS was significantly better in the BoNT-A group in the beading and sandwich-making task. The BoNT-A group also showed significant improvement in the quality scores of the OSAS: the wrist position during grasping and holding, especially in the younger children. The BITT group improved significantly on the AK and significantly more on the performance and satisfaction scores of the COPM at 12 and 24 weeks regarding several goals. BoNT-A showed a significant negative effect at 12 and 24 weeks in the most important goal. BITT, more than BoNT-A + BITT, showed positive effects on the GAS score at 12 (significant), 18 and 24 weeks.


CONCLUSIONS
BoNT-A has a positive effect on quality of movement and amount of use of the affected UE during the 3 months' working time. BoNT-A has no additional effect on bimanual performance and goal achievement. BITT has a positive effect on goal achievement and bimanual performance, even up to 6 weeks after therapy had stopped.


BACKGROUND
Current Controlled Trials ISRCTN69541857.
Adelante, Paediatric Rehabilitation, Onderstestraat 29, 6301 , KA, Valkenburg, The Netherlands. l.speth@adelante-zorggroep.nl.|Adelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. l.speth@adelante-zorggroep.nl.
Lucianne
L
Speth
Adelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. y.janssen-potten@adelante-zorggroep.nl.|Department of Rehabilitation Medicine, Maastricht University, Research School CAPHRI, PO Box 616, 6200 , MD, Maastricht, The Netherlands. y.janssen-potten@adelante-zorggroep.nl.
Yvonne
Y
Janssen-Potten
Adelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. eaa.rameckers@hetnet.nl.|Department of Rehabilitation Medicine, Maastricht University, Research School CAPHRI, PO Box 616, 6200 , MD, Maastricht, The Netherlands. eaa.rameckers@hetnet.nl.
Eugene
E
Rameckers
Adelante, Paediatric Rehabilitation, Onderstestraat 29, 6301 , KA, Valkenburg, The Netherlands. a.defesche@adelante-zorggroep.nl.
Anke
A
Defesche
Department of Methodology and Statistics, Maastricht University, Research School CAPHRI, Maastricht, The Netherlands. bjorn.winkens@maastrichtuniversity.nl.
Bjorn
B
Winkens
Department of Rehabilitation Medicine, Free University Medical Centre, De Boelelaan 1118, 1081 , HZ, Amsterdam, The Netherlands. jg.becher@vumc.nl.
Jules
J
Becher
Adelante, Centre of Expertise in Rehabilitation and Audiology, Zandbergsweg 111, 6432 , CC, Hoensbroek, The Netherlands. rob.smeets@mumc.nl.|Department of Rehabilitation Medicine, Maastricht University, Research School CAPHRI, PO Box 616, 6200 , MD, Maastricht, The Netherlands. rob.smeets@mumc.nl.|Department of Rehabilitation Medicine, Maastricht University Medical Centre, PO Box 5200, 6202 , AZ, Maastricht, The Netherlands. rob.smeets@mumc.nl.
Rob
R
Smeets
Department of Neurology, Maastricht University Medical Centre, Maastricht, The Netherlands. jsh.vles@mumc.nl.|Department of Neurology, Maastricht University, Research School GROW, Maastricht, The Netherlands. jsh.vles@mumc.nl.
Hans
H
Vles
D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000188:drug therapy* / Q000534:rehabilitation*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006225:Hand; D018737:Hand Strength; D006801:Humans; D008297:Male; D009068:Movement; D009788:Occupational Therapy / Q000379:methods*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D034941:Upper Extremity / Q000473:pathology; D014953:Wrist
D019274:Botulinum Toxins, Type A