. 2020 Mar 10;8(3):e0119. doi: 10.2106/JBJS.RVW.19.00119

TABLE I.

Patient Demographics, Assessment, and Outcomes After BTX-A Injection^*

Study	No. of Participants	Randomization	Mean Age (yr or yr+mo)	Sex, M:F	Bilateral CP Included^†	Time of Follow-up Assessment	Assessment of Spasticity and Muscle Tone	Result Compared with Controls	Functional Assessment	Result Compared with Controls
Corry et al.²⁵	14	7 treatment, 7 control	9	5:9	Yes	Baseline and 2 and 12 wk	Ashworth Scale, ROM, wrist resonance	All scores on these scales improved in treatment group	Grasp and release score, coin pickup for fine motor assessment	Improvement in grasp and release score, but not coin pickup score, in treatment group
Fehlings et al.²⁶	30	15 treatment, 15 control	BTX-A, 5.6 ± 2.6; control, 5.3 ± 2.3	20:10	No	Baseline and 1, 3, and 6 mo	MAS, PROM	No significant differences between groups	QUEST, grip strength, PEDI	Significant improvement in QUEST and slight improvement in PEDI in treatment group, but no significant difference in grip strength between groups
Speth et al.²⁷	20	10 treatment, 10 control	BTX-A, 9.4; control, 9.7	11:9	No	Baseline and 2 and 6 wk and 3, 6, and 9 mo	Ashworth Scale, AROM	Significant increase in ROM and tone reduction at the wrist in treatment group	MA, PEDI, 9-hole peg test	No significant difference between groups
Lowe et al.²⁸	42	21 treatment, 21 control	4	31:11	No	Baseline and 1, 3, and 6 mo	Ashworth Scale	Significant improvement in degree of spasticity and muscle tone in treatment group	QUEST, GAS, COPM, PEDI	Improvement in all scores except PEDI, which showed nonsignificant difference, in treatment group
Kawamura et al.²⁹	39	21 high dose (treatment), 18 low dose (control)	Low dose, 3.1; high dose, 2.6	22:17	Yes	Baseline and 1 and 3 mo	ROM	Slight improvement in both groups, but no difference between doses	QUEST, GAS, COPM, PEDI, grip strength	Small improvement in arm and hand function, but no significant difference between groups on any scale
Russo et al.³⁰	43	21 treatment, 22 control	BTX-A, 8.4; OT control, 8.7	23:20	No	Baseline and 3 and 6 mo	MAS, Tardieu Scale	Significant improvement in degree of spasticity and muscle tone in treatment group	AMPS, GAS, self-perception, PEDI, PedQL	Improvement in GAS at 3 mo after injection, but no difference between groups on any scale at 6 mo
Wallen et al.³¹	72	20 treatment group 1, 20 treatment group 2, 17 control group 1, 15 control group 2	BTX-A + OT, 5+8 ± 3+1; BTX-A, 6+7 ± 3+9; OT, 5+2 ± 2+11; control, 5+11 ± 2+10	46:26	Yes	Baseline, 2 wk, and 3 and 6 mo	Tardieu Scale, AROM, PROM	No significant difference between groups in all scales	COPM, GAS, QUEST, MA, PEDI	Significant improvement in COPM and GAS, but no significant difference between groups
Redman et al.³²	22	12 treatment, 10 control	BTX-A, 10.74; control, 10.55	10:12	No	Baseline and 1, 3, and 6 mo	NM	NM	NM	NM
Rameckers et al.³³	20	10 treatment, 10 control	9.5	NM	No	Baseline (2 wk before injection), 2 wk, 3 and 6 mo (end of therapy), and 3 mo after end of therapy	Ashworth Scale, AROM, PROM, SRA	Improvement in both groups, but no significant difference between groups	Isometric generated force, force production error, MA	No significant difference between groups, and report of weakness caused by BTX-A (treatment group)
Olesch et al.³⁴	22	11 treatment, 11 control	3+8	19:3	No	Primary outcomes, 3 mo; secondary outcomes, 3 and 6 mo later	Modified Tardieu Scale	Significant reduction in muscle tone in treatment group	COPM, GAS, QUEST, PDMS-FM	Significant improvement in GAS score in treatment group over control group, but no difference between groups in COPM, QUEST, and PDMS-FM
Rameckers et al.³⁵	20	10 treatment, 10 control	9.5	NM	No	2 wk and 6 mo (end of therapy) and 3 mo after end of therapy	Ashworth Scale, SRA, AROM, PROM	Improvement in both groups, but no significant difference between groups	Kinematic analysis (speed, accuracy, end point spread, performance)	Slight increase in speed and performance in BTX-A treatment group
Koman et al.³⁶	73	38 treatment, 35 control	BTX-A, 9; control, 9+11	47:26	Yes (45% of treatment group and 49% of control group)	By OT: screening, baseline, and 4, 8, 14, and 20 wk; by physician: baseline and 7, 20, and 27 wk	UERS for assessment of ROM of upper-limb joints	No significant difference between groups in UERS (shoulder, elbow, forearm, or hand), but greater improvement in mean wrist ROM scores in treatment group	MA, HC, Modified HC	Improvement on MA in treatment group (BTX-A) but not in HC and Modified HC
Ferrari et al.³⁷	27	11 treatment, 16 control	BTX-A, 7.36; control, 5.51	14:13	No	Baseline and 1, 3, and 6 mo	MAS, physician rating scale	No significant difference between groups	GAS, AHA, grip strength score, PEDI, CA, AK	Improvement on GAS and AHA scales in treatment group, but decrease in grip strength, in treatment group. PEDI, CA, and AK showed positive results but no significant difference between groups
Lidman et al.³⁸	20	10 treatment, 10 control	3+1	14:6	No	Baseline and 3 mo; rerated at 6 and 9 mo	AROM	Significant improvement in AROM in both groups, but no significant difference between groups	AHA, COPM	Improvement on AHA scale in treatment group, but no difference on the COPM between groups
Speth et al.³⁹	35	5 treatment group 1, 13 treatment group 2, 11 control group 1, 6 control group 2	7.14	NM	No	Baseline and 6, 12, 18, and 24 wk	NM	NM	COPM, GAS, AHA, OSAS, AK	Increase in amount of use of both hands and OSAS quality scores in the 2 treatment groups. No significant difference between groups regarding AHA. The BITT control group showed significantly better results than the 2 treatment groups on the GAS.

BTX-A = botulinum toxin A, CP = cerebral palsy, ROM = range of motion, PROM = passive ROM, QUEST = Quality of Upper Extremity Skill Test, PEDI = Pediatric Evaluation of Disability Inventory, AROM = active ROM, MA = Melbourne Assessment, GAS = Goal Attainment Scale, COPM = Canadian Occupational Performance Measure, OT = occupational therapy, MAS = Modified Ashworth Scale, AMPS = Assessment of Motor and Process Skill, PedQL = Pediatric Quality of Life, NM = not mentioned, PT = physical therapy, SRA = stretch resistive angle, PDMS-FM = Peabody Motor Scale-Fine Motor, UERS = Upper Extremity Rating Scale, HC = House Classification, AHA = Assistive Hand Assessment, CA = Caregiver Assistance, AK = ABILHSAND-Kids, OSAS = Observational Skill Assessment Scale, and BITT = Bimanual Task-Oriented Therapy.

^†

GMFCS level was reported in only 1 study²⁸.