Charles 2006.

Methods	Design: single‐centre, single‐blind, randomised controlled, cross‐over trial Comparison groups reported by study authors: CIMT vs delayed intervention control group (children received no treatment) Country: USA Other: no protocol or trial registration identified Groups defined by Cochrane authors Intervention: hybrid CIMT Comparison: low dose Comparison defined by Cochrane authors and used in meta‐analysis: CIMT vs low dose
Participants	Inclusion criteria (a) Ability to extend the wrist at least 20° and the fingers at least 10° from full flexion at the metacarpophalangeal joints (b) 50% difference between the involved and non‐involved hand on the Jebsen–Taylor Test of Hand Function (c) Scored within 1 SD of the mean on the Kaufman Brief Intelligence Test (d) Willingness to agree to intervention and testing procedures and travel to Columbia University for participation Exclusion criteria (a) Health problems not associated with CP (b) Seizures (c) Visual problems that would interfere with carrying out the intervention or testing (d) Severely increased muscle tone (modified Ashworth score greater than 3) (e) Orthopaedic surgery on the involved upper limb (f) Dorsal rhizotomy (g) Botulinum toxin therapy in the upper‐limb musculature during the past 6 months or wishing to receive it within the period of study (h) Intrathecal baclofen (i) Balance problems while wearing the sling Participants: 33 children with unilateral CP Randomisation method: randomisation was performed in groups of four children (i.e. rolling admission) with the intention to achieve an equal number in both the treatment and control groups; dropouts were replaced immediately. Dropouts: n = 4; intervention n = 3 (n = 2 withdrew before receiving intervention, n = 1 removed from intervention because interventionists felt child was unable to tolerate procedure), comparison n = 1 (participant declined to participate). Lost to follow‐up: intervention n = 5, comparison n = 2 Number of participants who received intended treatment: intervention n = 16, comparison n = 13 Number of participants who were analysed: total sample: n = 22; mean age = 6 years 8 months SD 1 year 4 months, range = 4 to 8 years; 14 males, 8 females; 12 left hemiplegia, 10 right hemiplegia; MACS not reported; GMFCS not reported Intervention group: n = 11; mean age = 6 years 9 months SD 2 years 2 months; 5 males, 6 females; 8 left hemiplegia, 3 right hemiplegia; MACS not reported; GMFCS not reported Comparison group: n = 11; mean age = 6 years 8 months SD 2 years 1 month; 9 males, 2 females; 4 left hemiplegia, 7 right hemiplegia; MACS not reported; GMFCS not reported
Interventions	Intervention group (Hybrid CIMT) Treatment dosage Length: 2 weeks Duration: 6 hours per day Frequency: 10 of 12 days Total dose of therapy time: face‐to‐face time with therapist = 60 hours Description Type of restraint device: Quote: "Children in the treatment group wore a sling on the non‐involved upper limb for the entire time during an intervention session (6 hours) and the sling was removed at the end of each session. The sling was strapped to the child’s trunk and the distal end was sewn shut to prevent use of the non‐involved hand" (p.636‐637) Hours per day restraint worn: 6 hours: Quote: "time out of the sling during the 6‐hour period was allowed for designated activities (e.g. toileting) and could not exceed 30 minutes per day" (p.637) Treatment environment: University clinical laboratory Individual or group: groups of 2 to 4 children Therapy providers: “trained interventionists” Models of practice: Quote: "During each 6‐hour session each child received individualised instruction from a trained interventionist involving specific practice of designated target movements. Children were engaged in play and functional activities that provided two types of structured practice (shaping and repetitive task practice) using the involved upper limb, especially the hand" (p.637) Home programme: Quote: "At the end of each day, each child in the treatment group went home with an exercise programme that involved practice with the involved limb (without any restraint) for 1 hour, which was extended to 2 hours per day for 6 months after the intervention. Parents kept activity logs to monitor compliance" (p.637 Comparison Group (low dose): children in this group received no treatment during the study period
Outcomes	Assessment time points: baseline; 1 week postintervention (immediately following intervention); 1 month postintervention; 6 months postintervention (5 to 6 months postintervention) Primary outcome measure Jebsen Taylor Test of Hand Function (modified; seconds; range 0 to 720). Reason for exclusion: Modified. No evidence of validity or reliability in CP Secondary outcome measures Two‐point discrimination test (1‐15 mm) Grip strength – Hand held dynamometer (units of measurement and score range unknown) Modified Ashworth scale (six point Likert scale 0,1,1+,2,3,4) Bruininks‐Oseretsky Test of Motor Proficiency ‐ Subtest 8 (modified; range unknown). Reason for exclusion: No evidence of validity or reliability in CP. Also used in modified form Caregiver Functional Use Scale (CFUS) ‐ How frequently and How well scales (raw scores summed and averaged; range 0‐5 points). Reason for exclusion: No evidence of validity or reliability in CP
Notes	Additional information sought from authors: authors provided change data for MAS, grip strength and 2‐point discrimination Question: Further description of the randomisation and allocation concealment procedures Reply: Quote: "In regard to the randomization and allocation concealment procedures: randomization and allocation was the responsibility solely of the project manager. Once randomization/allocation was completed, each study participant was given a code (by the project manager) for de‐identification and evaluation purposes. Thus the evaluators were blinded to allocation" Fundings sources: NIH grant HD 40961 from the National Center for Medical Rehabilitation Research (National Institute of Child Health and Human Development). Study author declaration: no declaration provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	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) Self‐reported outcomes	High risk	Comment: blinding for self‐reported outcomes including CFUS was not possible
Blinding of outcome assessment (detection bias) Objectively observed outcomes	Low risk	Quote: "The same evaluator, blind as to group assignment, performed all testing of a specific child" (p. 638)
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 19 children were allocated to the CIMT group, 11 were analysed (Reasons: 2 withdrew before receiving treatment; 1 could not tolerate it; 5 lost to follow‐up). 14 children were allocated to control, 11 were analysed (Reasons: 1 withdrew before receiving treatment; 2 lost to follow‐up). A large proportion of the sample was not included in analysis (33%). The attrition rates were unbalanced across groups and it is possible the attrition rates would affect outcomes. An as‐treated analysis was completed
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol located. Insufficient information to permit judgement