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. 2019 Oct 8;2019(10):CD001408. doi: 10.1002/14651858.CD001408.pub2

Boyd 2001.

Methods Method of randomisation: computer‐generated predetermined list. Randomisation stratified by motor distribution, age at the time of entry, and migration percentage.
Blinding: no blinding of participants and personnel. GMFM assessment was videotaped and analysed by 2 observers blinded to treatment. Decision to exit study to surgery done by a blinded observer.
Intention‐to‐treat analysis: yes
Loss of follow‐up:

    • BoNT‐A group: 1 interrupted because of an adverse event at 6 months

    • Control group: 3 underwent soft tissue surgery at 6 months

  • Graham 2008: 6

    • BoNT‐A group: 1 late exclusion, syrinx diagnosis; 1 abandoned; 2 death during treatment

    • Control group: 2 exited from control group to treatment group


Unit of analysis: child for global measures. Hip migration percentage analysed per limb.
Participants Place: 2 centres in Australia, Boyd 2001a, and 4 centres in Australia, Graham 2008
Period of study: patients recruited between 1997 and 2001
Number assigned: 39 Boyd 2001a; 91 Graham 2008
Number assessed: 35 Boyd 2001a; 85 Graham 2008

Inclusion criteria:

  • Bilateral spastic CP

  • Aged 1 to 4 years

  • Spastic adductors or scissoring position

  • Migration percentage 10% to 40%


Exclusion criteria:

  • Previous hip surgery

  • Hip abduction < 20°

  • Migration percentage > 40%

  • Hip flexion > 30°

  • Scoliosis Cobb > 20°


Age:

  • Boyd 2001a

    • BoNT‐A group (mean (SD)): 3.17 (0.83) years

    • Control group (mean (SD)): 3.25 (1.0) years

  • Graham 2008

    • BoNT‐A group (mean): 3.17 years

    • Control group (mean): 2.96 years

    • Note: SD not provided


Gender:

  • Graham 2008

    • BoNT‐A group: 28 males; 19 females

    • Control group: 31 males; 13 females


Motor distribution:

  • Boyd 2001a

    • BoNT‐A group: 9 diplegia; 9 quadriplegia

    • Control group: 7 diplegia; 14 quadriplegia

  • Graham 2008

    • BoNT‐A group: 15 diplegia; 32 quadriplegia

    • Control group: 14 diplegia; 30 quadriplegia


GMFCS:

  • Boyd 2001a

    • BoNT‐A group: 1 level II; 4 level III; 7 level IV; 7 level V

    • Control group: 0 level II; 7 level III; 6 level IV; 7 level V

  • Graham 2008

    • BoNT‐A group: 3 level II; 12 level III; 13 level IV; 19 level V

    • Control group: 2 level II; 6 level III; 21 level IV; 15 level V
Interventions BoNT‐A group:

  • BoNT‐A injections (onabotulinumtoxinA) in adductors and medial hamstrings (dose 4 U/kg to each muscle ‐ maximum total dose 16 U/kg) repeated every 6 months if:

    • Modified Ashworth Scale + 1;

    • abduction < 40°;

    • popliteal angle < 45°.

  • Combined SWASH orthosis 6 to 8 hours a day

  • No limits were placed on the amount of physical therapy, specialised seating, standing frames, gait aids, and below‐the‐knee orthosis


Control group:

  • No limits were placed on the amount of physical therapy, specialised seating, standing frames, gait aids, and below‐the‐knee orthosis
Outcomes Length of follow‐up:

  • Boyd 2001a

    • Follow‐up of 12 months

    • Assessments at baseline and 12 months

  • Graham 2008

    • Follow‐up of 36 months

    • Children were seen every 6 months


Primary outcomes:

  • Boyd 2001a

    • GMFM (total and goal scores)

    • GMFM‐66

    • Hip migration percentage


Secondary outcomes:

  • Boyd 2001a (unreported)

    • Range of motion

    • Modified Ashworth Scale

  • Graham 2008

    • Progression of hip displacement that led to surgery

    • Adverse events
Notes Comments:

  1. We grouped the Boyd 2001a and Graham 2008 reports under the Boyd 2001 study ID. The Graham 2008 report did not evaluate any of the main outcomes of interest for this review, except for adverse events.


Source of funding: supported by the National Health and Medical Research Council of Australia (NHMRC; grant no. 980753) and the Murdoch Children's Research Institute, The Royal Hobart Hospital Research Foundation, Tascare Society for Children, and the St John's Rehabilitation service. SWASH orthoses for the study were provided by Camp Ltd, Sweden.
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: computer‐generated, predetermined list
Allocation concealment (selection bias) Low risk Comment: central allocation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: no blinding of participants and personnel involved in treatment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: GMFM assessment was videotaped and analysed by 2 observers blinded to treatment. Hip migration percentage assessment was not blinded, but these data were not used for the purposes of this review.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no incomplete outcome data
Selective reporting (reporting bias) Unclear risk Comment: study protocol not available. It appears that the relevant outcomes were addressed.
Other bias Low risk Comment: no other sources of bias identified