Morrison 2013.
Study characteristics | ||
Methods | Randomised controlled two‐arm parallel trial | |
Participants | 22 children were approached to participate in the study. All were male, white, British, and FPI > +4 20 children consented to participate, then 5 failed to attend. 1 participant withdrew 14 participants (median age 7.5 years) completed the study Age: aged 6 to 11 years Gender; all white British boys Location: London, UK Setting: children’s physical rehabilitation programme (Children’s Therapy Service at Medway Community Healthcare) Inclusion criteria: diagnosis DCD, flat feet defined by FPI > +4 Exclusion criteria: medical complications likely to affect gait – neuromuscular, orthopaedic conditions Baseline characteristics: all boys, stated that groups were similar for age, foot posture, and hypermobility (but no demographic data) |
|
Interventions | ‐ CFOs (N = 9) ‐ no CFOs (N = 5) Both groups completed a 7‐week rehabilitation programme |
|
Outcomes | ‐ Spatio‐temporal gait (Gait‐rite system) ‐ Six‐minute walk test No significant differences from baseline to 7 week completion. |
|
Source of funding | Canonbury Healthcare funding | |
Notes | High attrition ‐ 14/21 (68%) finished the trial Small sample Specific cohort Preliminary trend inferred from NS results No true control group – quasi RCT |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | All participants entering the study were quasi‐randomised into one of the two groups..’. Method of randomisation unclear |
Allocation concealment (selection bias) | Low risk | ‘…using a sealed envelope technique. Each envelope was opened after the child consented to taking part in the programme’ |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants aware of foot orthoses being supplied at the start of end of rehabilitation program. Personnel supplied the orthoses at the start or end of the rehabilitation programme. |
Blinding of outcome assessment (detection bias) ‐ self‐reported outcomes (e.g., pain, function) | Unclear risk | N/A |
Blinding of outcome assessment (detection bias) ‐ objective outcomes | High risk | The investigator was blind to the treatment group during the initial data collection. It was not clear if investigators were blind at the time of outcome assessment at follow‐up. The gait parameters reported are influenced by the participants who were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons not provided for attrition. |
Selective reporting (reporting bias) | Unclear risk | No reference to study protocol. Insufficient information to permit judgement of low risk or high risk |
Other bias | Low risk | Source of funding declared and independence of funder from research design, conduct and reporting assured. |