Table K.4.2Evidence profile for active use therapy compared with no active use therapy in children with unilateral or bilateral spasticity; functioning assessment

Quality assessmentSummary of findings
No. of patientsEffectQuality
No. of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsActive use therapyNo active use therapyRelative (95% CI)Absolute (95% CI)
Assisting hand assessment (AHA) score at week 9 (range 0 to 100, change from baseline) (Better indicated by higher values)
1 study (Aarts 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious1none282223-MD 4.3 higher (0.28 to 8.32 higher)*Moderate
AHA score at week 17 (range 0 to 100, change from baseline) (Better indicated by higher values)
1 study (Aarts 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious1none284225-MD 4.70 higher (1.58 to 7.82 higher)*Moderate
Goal attainment scaling (GAS) score at week 9 (% children who showed an increase of 2 point or more compared to baseline)
1 study (Aarts 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone23/28*

(82%)
5/22*

(23%)
RR 3.61

(1.64 to 7.96)*
59 more per 100 (from 15 more to 100 more)*High
GAS score at week 17 (% children who showed an increase of 2 point or more compared to baseline)
1 study (Aarts 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone24/28*

(86%)
8/22*

(36%)
RR 2.36 (1.33 to 4.18)*49 more per 100 (from 12 more to 100 more)*High
GAS T-score at week 8 - 4week Occupational therapy home programme (OTHP) group (Better indicated by higher values)
1 study (Novak 2009)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone1112--6High
GAS T-score at week 8 - 8week OTHP group (Better indicated by higher values)
1 study (Novak 2009)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone1212--7High
GAS T-score at week 8 – 4week versus 8week OTHP group (Better indicated by higher values)
1 study (Novak 2009)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious 8none11129--10Moderate
Canadian occupational performance measure - performance (COPM-P) score at week 8 - 4week OTHP group (Better indicated by higher values)
1 study (Novak 2009)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone1112--11High
COPM-P score at week 8 - 8week OTHP group (Better indicated by higher values)
1 study (Novak 2009)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone1212--12High
COPM-P score at week 8 - 4week versus 8week OTHP group (Better indicated by higher values)
1 study (Novak 2009)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessserious 8none11129--13Moderate
COPM-P score at week 9 (range 0 to 10) (Better indicated by higher values)
1 study (Aarts 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone28142215--16High
COPM-P at week 17 (range 0 to 10, change from baseline) (Better indicated by higher values)
1 study (Aarts 2010)randomised trialsno serious limitationsno serious inconsistencyno serious indirectnessno serious imprecisionnone28172218-MD 2.00 higher (1.20 to 2.80 higher)*High
Walking speed at 6 weeks (change from baseline, m/s) (10m walk test) (Better indicated by higher values)
1 study (Katz-Leurer 2009)randomised trialsserious19no serious inconsistencyno serious indirectnessserious8none10201021-MD 0.03 higher (0.06 lower to 0.12 higher)Low

CI confidence interval, MD mean difference, RR relative risk

*

Calculated by the NCC-WCH

1

Total population less than 400, 95% confidence interval does not cross null effect but is wide. Small effect size (Cohen's d = 0.43) reported at week 9.

2

Change from baseline at week 9 Mean (standard deviation; SD) = 6.8 (8.2)

3

Change from baseline at week 9 Mean (SD) = 2.5 (6.3)

4

Change from baseline at week 17 Mean (SD) = 6.4 (5.7)

5

Change from baseline at week 17 Mean (SD) = 1.7 (5.5)

6

Results for comparison of 4 week OHTP versus no program reported as an effect size of 37.8 95% CI (26.9 to 48.8) p=0.01

7

Results for comparison of 8 week OHTP versus no program reported as an effect size of 17.9 95% CI (12.4 to 23.4) p=0.01

8

Total population less than 400, 95% confidence interval crosses null effect and is wide

9

Comparison is 4 weeks OHTP versus 8 weeks OHTP group, not to “no program” group

10

Results for comparison of 4 week OHTP versus 8 week OHTP reported as an effect size of 0.5 95% CI(-13.4 to 14.4) p=0.94

11

Results for comparison of 4 week OHTP versus no program reported as an effect size of 2.4 (0.7 to 4.2) p=0.01

12

Results for comparison of 8 week OHTP versus no program reported as an effect size of 1.4 (0.6 to 2.2) p=0.01

13

Results for comparison of 4 week OHTP versus 8 week OHTP reported as an effect size of 0.7 (-1.2 to 2.6) p=0.45

14

Change from baseline at week 9 Mean (SD) = 3.5 (1.3)

15

Change from baseline at week 9 Mean (SD) = 1.2 (1.1)

16

Mean difference (95% CI) reported as 2.1 (1.43 - 2.72) effect size reported as 1.31

17

Change from baseline at week 17 Mean (SD) = 3.6 (1.6)

18

Change from baseline at week 17 Mean (SD) = 1.6 (1.3)

19

Unclear if outcome assessors were blinded to treatment allocation

20

Change scores after 6 weeks Mean (SD) = 0.04 (0.1)

21

Change scores after 6 weeks Mean (SD) = 0.01 (0.1)

Calculated by the NCC-WCH

Total population less than 400, 95% confidence interval does not cross null effect but is wide. Small effect size (Cohen's d = 0.43) reported at week 9.

Change from baseline at week 9 Mean (standard deviation; SD) = 6.8 (8.2)

Change from baseline at week 9 Mean (SD) = 2.5 (6.3)

Change from baseline at week 17 Mean (SD) = 6.4 (5.7)

Change from baseline at week 17 Mean (SD) = 1.7 (5.5)

Results for comparison of 4 week OHTP versus no program reported as an effect size of 37.8 95% CI (26.9 to 48.8) p=0.01

Results for comparison of 8 week OHTP versus no program reported as an effect size of 17.9 95% CI (12.4 to 23.4) p=0.01

Total population less than 400, 95% confidence interval crosses null effect and is wide

Comparison is 4 weeks OHTP versus 8 weeks OHTP group, not to “no program” group

Results for comparison of 4 week OHTP versus 8 week OHTP reported as an effect size of 0.5 95% CI(-13.4 to 14.4) p=0.94

Results for comparison of 4 week OHTP versus no program reported as an effect size of 2.4 (0.7 to 4.2) p=0.01

Results for comparison of 8 week OHTP versus no program reported as an effect size of 1.4 (0.6 to 2.2) p=0.01

Results for comparison of 4 week OHTP versus 8 week OHTP reported as an effect size of 0.7 (-1.2 to 2.6) p=0.45

Change from baseline at week 9 Mean (SD) = 3.5 (1.3)

Change from baseline at week 9 Mean (SD) = 1.2 (1.1)

Mean difference (95% CI) reported as 2.1 (1.43 - 2.72) effect size reported as 1.31

Change from baseline at week 17 Mean (SD) = 3.6 (1.6)

Change from baseline at week 17 Mean (SD) = 1.6 (1.3)

Unclear if outcome assessors were blinded to treatment allocation

Change scores after 6 weeks Mean (SD) = 0.04 (0.1)

Change scores after 6 weeks Mean (SD) = 0.01 (0.1)

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.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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