Table K.7.4Evidence profile for botulinum toxin type A and physical therapy compared with physical therapy alone; lower limb; functioning assessment

Quality assessmentSummary of findings
Mean ± SDEffectQuality
No. of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsBotulinum toxin (BoNT) + physical therapyPhysical therapy onlyRelative

(95% CI)
Absolute
Gross Motor Function Measure (GMFM) (version not reported): Dimensions C, D and E (Crawling and kneeling, Standing, Walking, running and jumping) per cent score mean change 3 months (Better indicated by higher values)
1 study (Kay 2004)randomised trialsserious1no serious inconsistencyno serious indirectnessserious2none16 limbs320 limbs4MD 3.8 higher (0.5 lower to 8.1 higher)*Low
GMFM (version not reported): Dimensions C, D and E (Crawling and kneeling, Standing, Walking, running and jumping) per cent score mean change 6 months (Better indicated by higher values)
1 study (Kay 2004)randomised trialsserious5no serious inconsistencyno serious indirectnessserious2none16 limbs620 limbs7MD 1.01 higher (1.13 lower to 3.15 higher)*Low
GMFM (version not reported): Total score mean change 3 months (Better indicated by higher values)
1 study (Reddihough 2002)randomised trialsserious8no serious inconsistencyno serious indirectnessserious2none1991910MD 1.33 lower (5.12 lower to 2.46 higher)*Low
GMFM (version not reported): Total score mean change 6 months (Better indicated by higher values)
1 study (Reddihough 2002)randomised trialsserious8no serious inconsistencyno serious indirectnessserious2none19111912MD 0.16 higher (4.37 lower to 4.69 higher)*Low
GMFM (version not reported): Total score with aids mean change 3 months (Better indicated by higher values)
1 study (Reddihough 2002)randomised trialsserious8no serious inconsistencyno serious indirectnessserious2none713714MD 3.72 higher (7.56 lower to 15 higher)Low
GMFM (version not reported): Total score with aids mean change 6 months (Better indicated by higher values)
1 study (Reddihough 2002)randomised trialsserious8no serious inconsistencyno serious indirectnessserious2none24152416MD 7.19 lower (13.64 to 0.74 lower)Low
GMFM (version not reported): Walking and running: Proportion of participants who showed greater than 6% change in the GMFM score at 12 weeks (Better indicated by higher values)
1 study (Ubhi 2000)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious17selective outcome reporting187/19191/1520-21Low
Velocity (metres/second) mean change 3 months (as reported, read from graph) (Better indicated by higher values)
1 study (Ackman 2005)randomised trialsserious22no serious inconsistencyno serious indirectnessserious23none12241325MD 0.2 higher*Low
Velocity (metres/second) mean change 6 months (as reported, read from graph) (Better indicated by higher values)
1 study (Ackman 2005)randomised trialsserious22no serious inconsistencyno serious indirectnessserious23none12261327MD 0.05 higher*Low

CI confidence interval, MD mean difference

*

Calculated by the NCC-WCH

1

Outcome assessors not blinded to treatment allocation.

2

Total population less than 400, 95% confidence interval for mean difference crosses null hypothesis and is wide. p= no statistically significant difference reported

3

Mean change from baseline ± standard deviation (SD) = 2.5 ± 7.5

4

Mean change from baseline ± SD = -1.3 ± 5.1

5

Outcome assessors not blinded to treatment allocation. Results estimated from graphs

6

Mean change from baseline ± SD = 2.84 ± 3.33

7

Mean change from baseline ± SD = 1.83±3.17

8

No allocation concealment. Serious attrition

9

Mean change from baseline ± SD = 2.70 ± 4.62

10

Mean change from baseline ± SD = 4.03 ± 7.05

11

Mean change from baseline ± SD = 3.60 ± 7.44

12

Mean change from baseline ± SD = 3.44 ± 6.79

13

Mean change from baseline ± SD = 6.52 ± 4.95

14

Mean change from baseline ± SD = 2.80 ± 14.40

15

Mean change from baseline ± SD = 3.94 ± 11.60

16

Mean change from baseline ± SD = 11.13 ± 11.18

17

Total population less than 400, 95% confidence interval not reported by authors

18

Numerical details are not presented for other GMFM dimensions, although these are stated as not being statistically significant

19

This group received BoNT-A, physiotherapy and orthotic treatment.

20

This group received placebo, physiotherapy and orthotic treatment

21

χ2 = 4.24, p = 0.04 reported by authors

22

No analysis or results across groups provided, results estimated from graphs

23

Total population less than 400, 95% confidence interval of mean difference of change not calculable

24

Mean change from baseline = 0.15 no SD reported

25

Mean change from baseline = -0.05 no SD reported

26

Mean change from baseline = 0.1 no SD reported

27

Mean change from baseline = 0.05 no SD reported

Calculated by the NCC-WCH

Outcome assessors not blinded to treatment allocation.

Total population less than 400, 95% confidence interval for mean difference crosses null hypothesis and is wide. p= no statistically significant difference reported

Mean change from baseline ± standard deviation (SD) = 2.5 ± 7.5

Mean change from baseline ± SD = -1.3 ± 5.1

Outcome assessors not blinded to treatment allocation. Results estimated from graphs

Mean change from baseline ± SD = 2.84 ± 3.33

Mean change from baseline ± SD = 1.83±3.17

No allocation concealment. Serious attrition

Mean change from baseline ± SD = 2.70 ± 4.62

Mean change from baseline ± SD = 4.03 ± 7.05

Mean change from baseline ± SD = 3.60 ± 7.44

Mean change from baseline ± SD = 3.44 ± 6.79

Mean change from baseline ± SD = 6.52 ± 4.95

Mean change from baseline ± SD = 2.80 ± 14.40

Mean change from baseline ± SD = 3.94 ± 11.60

Mean change from baseline ± SD = 11.13 ± 11.18

Total population less than 400, 95% confidence interval not reported by authors

Numerical details are not presented for other GMFM dimensions, although these are stated as not being statistically significant

This group received BoNT-A, physiotherapy and orthotic treatment.

This group received placebo, physiotherapy and orthotic treatment

χ2 = 4.24, p = 0.04 reported by authors

No analysis or results across groups provided, results estimated from graphs

Total population less than 400, 95% confidence interval of mean difference of change not calculable

Mean change from baseline = 0.15 no SD reported

Mean change from baseline = -0.05 no SD reported

Mean change from baseline = 0.1 no SD reported

Mean change from baseline = 0.05 no SD reported

From: Appendix K, GRADE tables

Cover of Spasticity in Children and Young People with Non-Progressive Brain Disorders
Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications.
NICE Clinical Guidelines, No. 145.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2012 Jul.
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