Rostami 2012b.

Methods	Design: randomised controlled trial Comparison groups reported by study authors: CIMT plus virtual reality vs virtual reality vs CIMT vs usual care Country: Iran Other: no protocol or trial registration identified Groups defined by Cochrane authors Intervention 1: mCIMT plus VR Comparison 1: VR alone Intervention 2: mCIMT alone Comparison 2: VR alone Intervention 3: mCIMT alone Comparison 3: low dose Comparison defined by Cochrane authors (not used in meta‐analysis as no data available) Comparison 1: CIMT plus VR vs dose‐matched (VR) Comparison 2: CIMT vs dose‐matched (VR) Comparison 3: CIMT vs low dose
Participants	Inclusion criteria (a) Spastic unilateral CP (b) At least 20° of wrist extension and 10° active finger extension from full flexion (c) More movement deficits in one upper limb (less than 2.5 on the Amount of Use scale on the PMAL) (d) Muscle tone less than 3 on the Modified Ashworth Scale (e) Age range between 6 to 12 years (f) Normal or corrected to normal vision and hearing Exclusion criteria (a) Health problems not associated with CP (b) Seizures (c) Hemispatial neglect (d) Orthopaedic surgery on the involved upper limb (e) Botulinum toxin therapy for the affected upper limb within past 6 months (f) Balance problems Participants: 32 children with spastic unilateral CP were randomised Randomisation method: once baseline evaluations were completed, children were matched based on age and randomly assigned to one of 4 study groups using a computer generated random number list. Randomisation process was performed by one of the researchers blinded to the intervention types Dropouts: n = 0 Number of participants who received intended treatment: CIMT n = 8, VR plus CIMT n = 8, VR n = 8, control n = 8 Number of participants who were analysed: total sample: n = 32; mean age = 8 years 1 month SD not reported, range = 6 years 2 months to 11 years 8 months; 14 males; 18 females; 18 left hemiplegia; 14 right hemiplegia; MACS not reported; GMFCS not reported CIMT group: n = 8; mean age = 8 years 4 months SD not reported; 4 males; 4 females; 6 left hemiplegia, 2 right hemiplegia; MACS not reported; GMFCS not reported CIMT plus VR group: n = 8; mean age = 8 years 2 months SD not reported; 4 males, 4 females; 5 left hemiplegia, 3 right hemiplegia; MACS not reported; GMFCS not reported VR group: n = 8; mean age = 7 years 8 months SD not reported; 3 males, 5 females; 3 left hemiplegia, 5 right hemiplegia; MACS not reported; GMFCS not reported Low‐dose comparison group: n = 8; mean age = 8 years 0 months SD not reported; 3 males, 5 females; 4 left hemiplegia, 4 right hemiplegia; MACS not reported; GMFCS not reported
Interventions	Intervention group (mCIMT plus VR) Treatment dosage Length: 4 weeks Duration: 1.5 hours Frequency: 3 days per week Total dose of therapy time: 22 hours (18 hours virtual therapy + continued routine therapy (2 x 0.5 ‐hour sessions per week = 4 hours total)) Description Type of restraint device: Volar resting splint extending from fingertips to the proximal forearm Hours per day restraint worn: 5 hours Treatment environment: clinic Individual or group: individual Therapy provider: therapist – no further detail provided Models of practice: children selected their favourite games, while therapist choose the appropriate handles and suitable aspects of games including required range of motion, strength, speed, accuracy, and difficulty, according to the children’s abilities Home programme: not reported Intervention Group (mCIMT) Treatment dosage Length: 4 weeks Duration: 1.5 hours Frequency: 3 days per week Total dose of therapy time: 22 hours (18 hours CIMT + continued routine therapy (2 x 0.5 hour sessions per week = 4 hours total)) Description Type of restraint device: Volar resting splint extending from fingertips to the proximal forearm Hours per day restraint worn: 5 hours Treatment environment: clinic Individual or group: individual Therapy provider: therapist – no further detail provided Models of practice: intervention included daily activities such as reaching, grasping, manipulating objects or toys, dressing and undressing, eating, and grooming, according to the child’s age and abilities. Frequent and immediate visual and auditory feedback about the success of the action was presented to children by the system to encourage both participation and attention and to increase the child’s knowledge of their performance either during practice or at the end of practice Home programme: not reported Comparison group (VR Group) Treatment dosage Length: 4 weeks Duration: 1.5 hours Frequency: 3 times per week Total dose of therapy time: 22 hours (18 hours VR + continued routine therapy (2 x 0.5 hour sessions per week = 4 hours total)) Description Treatment environment: clinic Individual or group: iIndividual Therapy provider: therapist – no further detail provided Models of practice: children selected their favourite games, while therapist choose the appropriate handles and suitable aspects of games including required range of motion, strength, speed, accuracy, and difficulty, according to the children’s abilities Home programme: not reported Comparison group (low dose) Treatment dosage Length: 4 weeks Duration: 0.5 hours Frequency: 2 times per week Total dose of therapy time: 4 hours Description Treatment environment: not reported Individual or group:individual Therapy provider: therapist Models of practice: neurodevelopmental facilitation techniques, range of motion exercises, and stretching Home programme: not reported
Outcomes	Assessment time points: baseline 1 week prior to intervention; baseline 1 day prior to intervention; postintervention (immediately following intervention); 3 months (2 weeks to 4 months postintervention) Primary outcome measures Not stated Secondary outcome measures Pediatric Motor Activity Log. Reason for exclusion: Version used is unknown Bruninks‐Oseretsky Test of Motor Proficiency subtest 8 (range 0 to 9). Reason for exclusion: No evidence of validity or reliability in CP
Notes	Fundings sources: Ahvaz Jundishapur University of Medical Sciences (grant no. U‐89071) Study author declaration: no declaration given
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Once baseline evaluations were completed, children were matched based on age and randomly assigned to one of 4 study groups (VR, modified CIMT, combined VR and modified CIMT, or control) using a computer generated random number list”
Allocation concealment (selection bias)	High risk	Quote: “Randomisation process was performed by one of the researchers blinded to the intervention types”
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: binding of participants and personnel was not possible
Blinding of outcome assessment (detection bias) Self‐reported outcomes	High risk	Comment: binding for self‐reported outcomes including PMAL was not possible
Blinding of outcome assessment (detection bias) Objectively observed outcomes	Low risk	Quote: “An assessor blinded to group assignment administered the BOTMP”
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: the CONSORT diagram indicated that all children received intervention and completed follow‐up assessment. Completion of an intention‐to‐treat analysis was not specified
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol located. Insufficient information to permit judgement