Yu 2012.
| Methods |
Design: single‐centre, randomised controlled trial Comparison groups reported by study authors: mCIMT vs traditional therapy Country: Korea Other: no protocol or trial registration identified Groups defined by Cochrane authors
Comparison defined by Cochrane authors and used in meta‐analysis: CIMT vs low dose |
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| Participants |
Inclusion criteria (a) Unilateral CP (b) Not undertaken CIMT in previous 2 years (c) Voluntary movement not limited when non‐affected side is restrained (d) No difficulties in performing PROM exercised and some active ROM (voluntary wrist extension and voluntary finger extension of 10° degrees or more) on affected side (e) No cognitive deficits (able to understand the instructions of therapists) Exclusion criteria
Participants: 24 participants with unilateral CP were randomised Randomisation method: table of random sampling numbers used, allocation concealment unclear Dropouts: n = 4 dropouts. Reasons for dropouts were not reported Number of participants who received intended treatment: unclear if dropouts received treatment Number of participants who were analysed: total sample: n = 20; mean age = 9.4 years SD 0.34 years (calculated by review authors); 13 males, 7 females; side of hemiplegia not reported; MACS not reported; GMFCS not reported Intervention group: n = 10; mean age = 9.4 years SD 0.3 years; 7 males, 3 females; side of hemiplegia not reported; MACS not reported; GMFCS not reported Comparison group: n = 10; mean age = 9.4 years SD 0.4 years; 6 males; 4 females; side of hemiplegia not reported; MACS not reported; GMFCS not reported |
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| Interventions |
Intervention group (mCIMT) Treatment dosage Length: 10 weeks Duration: 1 hour per session Frequency: 2 sessions per week Total dose of therapy time: 20 hours Description Type of restraint device: sling and splint made of a light material. Arm position during restraint was 90° elbow flexion, 20° wrist extension, and 20° finger joint flexion Hours per day restraint worn: planned = unclear. Actual = unclear. Treatment environment: clinic Individual or group: group (size not specified) Therapy provider: experienced physical therapists Models of practice: unclear Home programme: unclear Comparison group (low dose) Length: 10 weeks Duration: 30 minute sessions Frequency: 2 sessions per week Total dose of therapy time: 10 hours Description Treatment environment: clinic (assumed, not specified) Individual or group: group (size not reported) Therapy provider: experienced physical therapists Models of practice: no details of intervention given Home programme: unclear |
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| Outcomes |
Assessment time points: baseline; 10 weeks (immediately post‐intervention) Primary outcome measures
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| Notes |
Additional information sought from authors: authors contacted via email (otsalt@nate.com) on 09/05/2015 and 03/07/2015 for change from baseline data but no response received Fundings sources: nil funding reported Study author declaration : no declaration given |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: “Randomized using a table of random sampling numbers” |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding of participants and personnel was not possible |
| Blinding of outcome assessment (detection bias) Objectively observed outcomes | Unclear risk | Quote: “single‐blind analysis” Comment: does not specify who is blinded. Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: four dropouts, but the reasons or group were not specified. Completion of an intention‐to‐treat analysis was not specified. Insufficient information to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | Comment: no study protocol located. Insufficient information to permit judgement |