Eugster‐Buesch 2012.

Methods	Design: multi‐centre, single‐blind, randomised controlled trial Comparison groups reported by study authors: forced use vs usual care Country: Switzerland Other: no protocol or trial registration identified Groups defined by Cochrane authors Intervention:mCIMT Comparison: low dose Comparison defined by Cochrane authors and used in meta‐analysis: CIMT vs low dose
Participants	Inclusion criteria (a) 6 to16 years (b) Unilateral CP (c) GMFCS Levels I or II (d) Able to lift impaired arm against gravity and grasp a lightweight item such as pen from a desk (e) Secure balance while standing and sitting (f) Able to understand and follow therapists’ instruction Exclusion criteria None stated Participants: 23 children with unilateral CP Randomisation method: not clearly stated Dropouts: n = 0 prior to primary end point; 14 lost to follow‐up at 12 months Number of participants who received intended treatment: n = 23 (100%); intervention n = 12, comparison n = 11 Number of participants who were analysed: total sample: n = 23; mean age = 10 years 8 months SD 7 years 9 months, range = 6 years 0 months to 16 year 11 months; 12 males, 11 females; side of hemiplegia not reported; MACS not reported; GMFCS not reported Intervention group: n = 12; mean age = 9.8 years SD 3.5 years, range = 6 years 0 months to 15 years 6 months; 5 males, 7 females; side of hemiplegia not reported; MACS not reported; GMFCS not reported Comparison group: n = 11; mean age = 11.7 years SD = 3.7 years, range = 6 years 1 month to 16 years 11 months; 7 males, 4 females; side of hemiplegia not reported; MACS not reported; GMFCS not reported
Interventions	Intervention group (mCIMT) Treatment dosage Length: 2 weeks Duration: 2 hours per day of age appropriate ADL and play, 4 hours per day without formal therapy or training; 1 hour per week of usual therapy. Frequency: daily Total dose of therapy time: 84 hours of constraint use which included 2 hours of ADL activities Description Type of restraint device: removable Softcast with Velcro fastenings (forearm to fingertips) Hours per day restraint worn: planned: 6 hours per day, actual: 72% of participants (n = 8) reported having always (45%) or often (27%) reached the 6 hours/day target for duration of cast wear. The rest achieved the target sometimes (n = 2) or rarely (n = 1). Treatment environment: home and clinic (participants had 1 session of therapy each week) Individual or group: individual Therapy provider: parents Models of practice: none prescribed Home programme: all the therapy was completed at home Comparison group (low dose) No information on the comparison group in this study were reported
Outcomes	Assessment time points: baseline: 2 weeks prior to intervention; Pretest: immediately prior to intervention; Post‐test 1: Immediately following intervention; Post‐test 2: 2 weeks after intervention (2 weeks to 4 months postintervention); Post‐test 3: 3 months after intervention (2 weeks to 4 months postintervention); Post‐test 4: 12 months after intervention (7 to 12 months postintervention) Primary outcome measure Melbourne Assessment of Unilateral Upper Limb (% score, range 0 to 100) Investigator developed questionnaire. Reason for exclusion: No evidence of validity or reliability in CP
Notes	12‐month data not reported by study authors. Additional information sought from authors Question: Following review of your study we would like to seek clarification on how many children were recruited to the study, how many children were randomised to each group and the number of dropouts at each assessment for each group. Reply: CONSORT diagram sent. Summary as follows: Assessed for eligibility: n = 27; Excluded n = 4 Allocated to group: CIMT (n=12); comparison (n=11) Received allocated intervention: CIMT (n = 12 ); comparison (n = 11) Lost to follow‐up (postintervention): CIMT (n = 0 ); comparison ( n =1) Lost to follow‐up (2 weeks postintervention): CIMT (n = 0 ); comparison (n = 0) Lost to follow‐up (3 months postintervention): CIMT (n = 1 ); comparison (n = 1) Lost to follow‐up (12 months postintervention): CIMT (n = 5 ); comparison (n = 9) Fundings sources: Stiftung Cerebral, Switzerland. Study author declaration: the authors report no conflict of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Patients were randomly assigned either into control group (C) or intervention group (I) by the study coordination center using sealed envelopes” Comment: Insufficient information about the sequence generation process to permit judgement
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	Low risk	Quote: “The raters were blinded to group allocation of a child and were not involved in the recruiting process or in the therapy sessions”
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: additional data from authors confirmed that 1 child from the comparison group was not assessed immediately after intervention (due to illness), one child from each group was not assessed at 3 months (reasons unknown), and that only 14 children, mostly from treatment group were assessed at 12 months. There is, therefore, a low risk of bias up to the 3 months follow‐up with minimal and balanced drop out; and high risk of bias at 12 months with high and unbalanced drop out
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol located. Insufficient information to permit judgement