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Table K.5.5Evidence profile for hinged ankle foot orthosis with plantarflexion stop compared with solid ankle foot orthosis in children with diplegia; lower limb; joint movement assessment

Quality assessmentSummary of findings
No. of patientsEffectQuality
No. of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther considerationsHinged ankle-foot orthosis (HAFO)Solid ankle-foot orthosis (SAFO)Relative (95% CI)Absolute (95% CI)
Ankle dorsiflexion Initial contact (Better indicated by higher values)
1 study (Rethlefsen 1999)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious 2none42 limbs342 limbs4-MD = 1.00 higher (0.94 lower to 2.94 higher)*Low
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious 2none165166-MD = 0.20 lower (3.03 lower to 2.63 higher)*Low
Ankle dorsi/plantarflexion at initial contact - post hoc analysis (Better indicated by higher values)
1 study (Radtka 2002)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious 2selective outcome reporting7128129-MD = 1.72 lower (6.61 lower to 3.17 higher)*Low
Ankle dorsiflexion, terminal stance (Better indicated by higher values)
1 study (Rethlefsen 1999)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious10none42 limbs42 limbs-MD = 5.00 higher (2.82 higher to 7.18 higher)*Low
1 study (Radtka 2002)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious13,14selective outcome reporting712151216-MD = 4.63 higher (0.38 higher to 8.88 higher)*Low
Peak dorsiflexion stance (Better indicated by higher values)
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessno serious imprecisionnone16171618-MD = 6.10 higher (1.27 higher to 10.93 higher)*Moderate
Peak dorsiflexion time, % (Better indicated by higher values)
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessno serious imprecisionnone16191620-MD = 10.00 higher (3.18 higher to 16.82 higher)*Moderate
Peak dorsiflexion swing (Better indicated by higher values)
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious 2none16211622-MD = 1.10 higher (2.75 lower to 4.95 higher)*Low
Range (Better indicated by higher values)
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessno serious imprecisionnone16231624-MD = 5.90 higher (2.54 higher to 9.26 higher)*Moderate
Ankle range Dorsiflexion knee extension, degree (Better indicated by higher values)
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious2none16251626-MD = 2.00 higher (2.22 lower to 6.22 higher)*Low
Dorsiflexion knee flexion, degrees (Better indicated by higher values)
1 study (Buckon 2004a)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious2none16271628-MD = 4.00 higher (0.90 lower to 8.90 higher)*Low
Knee, initial contact (degrees) (Better indicated by higher values)
1 study (Rethlefsen 1999)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious242 limbs2942 limbs30MD = 2.00 higher (2.92 lower to 6.92 higher)*Low
Knee, terminal stance (degrees) (Better indicated by higher values)
1 study (Rethlefsen 1999)randomised studyserious limitations1no serious inconsistencyno serious indirectnessserious242 limbs3142 limbs32MD = 2.00 higher (2.28 lower to 6.28 higher)*Low

CI confidence interval, MD mean difference

*

Calculated by the NCC-WCH

1

All outcomes have serious limitations as although randomisation was performed, no details are given, blinding of assessors and caregivers was not carried out and the means presented are not “mean changes from baseline” but are “mean values from observations made in a given treatment period”.

2

Total population less than 400, 95% confidence interval for mean difference crosses null hypothesis and confidence intervals are wide

3

Mean final score ± standard deviation (SD) reported as 4 ± 5

4

Mean final score ± SD reported as 3 ± 4

5

Mean final score ± SD reported as 4.8 ± 4.6

6

Mean final score ± SD reported as 5.0 ± 4.5

7

Post hoc analysis of data

8

Mean final score ± SD reported as 5.37 ± 7.00

9

Mean final score ± SD reported as 7.09 ± 5.06

10

Total population less than 400, 95% confidence interval for mean difference does not cross null hypothesis, however analysis is by limb.

11

Mean final score ± SD reported as 13 ± 6

12

Mean final score ± SD reported as 8 ± 4

13

Total population less than 400, 95% confidence interval for mean difference does not cross null hypothesis but is wide

14

P < 0.05 (reported)

15

Mean final score ± SD reported as 16.13 ± 6.17

16

Mean final score ± SD reported as 11.50 ± 4.28

17

Mean final score ± SD reported as 18.6 ± 8.3

18

Mean final score ± SD reported as 12.5 ± 5.3

19

Mean final score ± SD reported as 46 ± 5

20

Mean final score ± SD reported as 36 ±13

21

Mean final score ± SD reported as 8.3 ± 5.5

22

Mean final score ± SD reported as 7.2 ± 5.6

23

Mean final score ± SD reported as 16.5 ± 5.7

24

Mean final score ± SD reported as 10.6 ± 3.8

25

Mean final score ± SD reported as 10 ± 7

26

Mean final score ± SD reported as 8 ± 5

27

Mean final score ± SD reported as 19 ± 8

28

Mean final score ± SD reported as 15 ± 6

29

Mean final score ± SD reported as 28 ± 12

30

Mean final score ± SD reported as 26 ± 11

31

Mean final score ± SD reported as 13 ± 10

32

Mean final score ± SD reported as 11 ± 10

Calculated by the NCC-WCH

All outcomes have serious limitations as although randomisation was performed, no details are given, blinding of assessors and caregivers was not carried out and the means presented are not “mean changes from baseline” but are “mean values from observations made in a given treatment period”.

Total population less than 400, 95% confidence interval for mean difference crosses null hypothesis and confidence intervals are wide

Mean final score ± standard deviation (SD) reported as 4 ± 5

Mean final score ± SD reported as 3 ± 4

Mean final score ± SD reported as 4.8 ± 4.6

Mean final score ± SD reported as 5.0 ± 4.5

Post hoc analysis of data

Mean final score ± SD reported as 5.37 ± 7.00

Mean final score ± SD reported as 7.09 ± 5.06

Total population less than 400, 95% confidence interval for mean difference does not cross null hypothesis, however analysis is by limb.

Total population less than 400, 95% confidence interval for mean difference does not cross null hypothesis but is wide

P < 0.05 (reported)

Mean final score ± SD reported as 16.13 ± 6.17

Mean final score ± SD reported as 11.50 ± 4.28

Mean final score ± SD reported as 18.6 ± 8.3

Mean final score ± SD reported as 12.5 ± 5.3

Mean final score ± SD reported as 46 ± 5

Mean final score ± SD reported as 36 ±13

Mean final score ± SD reported as 8.3 ± 5.5

Mean final score ± SD reported as 7.2 ± 5.6

Mean final score ± SD reported as 16.5 ± 5.7

Mean final score ± SD reported as 10.6 ± 3.8

Mean final score ± SD reported as 10 ± 7

Mean final score ± SD reported as 8 ± 5

Mean final score ± SD reported as 19 ± 8

Mean final score ± SD reported as 15 ± 6

Mean final score ± SD reported as 28 ± 12

Mean final score ± SD reported as 26 ± 11

Mean final score ± SD reported as 13 ± 10

Mean final score ± SD reported as 11 ± 10

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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