Zeifang 2005.
| Methods | RCT, two‐arm parallel group design | |
| Participants | 36 participants with 36 CTEV feet who presented to a single centre Inclusion criteria: idiopathic CTEV. Failed conservative treatment for 6 months. Dimeglio grade III. Underwent posteromedial lateral release Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS In bilateral cases, one foot was randomly selected by tossing a coin 1 bilateral case with early relapse was excluded prior to data analysis (leaving 37 participants with 37 feet for analysis) Age mean (range) in months: 8.2 (5 to 12) Sex male (%): 71% CPM Characteristics of feet: 18 feet Immobilisation in a cast Characteristics of feet: 19 feet |
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| Interventions | CPM versus immobilisation in a cast, after surgery for resistant CTEV Randomisation of participants. However, bilateral feet received the same postoperative management. In both groups a cast was applied postoperatively for the first 10 days. Kirschner wires were removed from all feet 2 weeks postoperatively In the casting group, casting for another 4.5 weeks was undertaken In the CPM group, computer‐assisted 3‐dimensional therapy using a Kinetic 5090 Ankle CPM machine was used with a standardised protocol. CPM was applied for 4 hours per day. During rest periods, removable splints were applied 6 weeks after surgery, all feet were treated with a brace at night. Physiotherapy was provided to both groups for a further 6 months. When the participants began to walk, they were provided with heel cups to place in conventional shoes Follow‐up: 48 months |
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| Outcomes | Dimeglio scale | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer number generation |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding (performance bias and detection bias) All outcomes | High risk | Intervention provider could not be blinded. Assessors were blinded. Participant and carer blinding not possible, which could affect outcome |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Two feet were lost to follow‐up. One participant was excluded after randomisation and removed from data analysis |
| Selective reporting (reporting bias) | High risk | Compliance with CPM unclear. No measurement of pain postoperatively |
| Other bias | Unclear risk | Insufficient information to permit judgement |