Choudhary 2013.
| Methods |
Design: single‐centre, single‐blind, parallel groups, randomised controlled trial Comparison groups reported by study authors: mCIMT vs usual care Country: India Other:trial was registered in Clinical Trials Registry of India 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) Aged 3 to 8 years (b) Unilateral CP (c) Minimum difference of 10 points between upper limbs on QUEST (d) Able to understand simple one‐step commands (e) Able to sit without support (f) Able to see 1 inch object from 1 metre Exclusion criteria (a) Uncontrolled epilepsy (seizure frequency of more than 1 episode/month during past 3 months) (b) MAS ≥3 at shoulder, elbow or wrist (c) Recent orthopaedic surgery or casting in preceding 6 months (d) Splint on the affected upper limb (e) Botulinum toxin or phenol in upper limb during past 6 months or plan to receive it during study period (f) Taking tone‐modifying agents such as baclofen, tizanidine, benzodiazepines or dantrolene Participants: 31 children with unilateral CP Randomisation method: a computer‐generated random number table was used Dropouts: n = 0 (at primary outcome measure point) Number of participants who received intended treatment: n = 31 (100%); intervention n = 16, comparison n = 15 Number of participants who were analysed: total sample: n = 31; mean age = 60.53 months SD 17.67 months (calculated by review authors); 18 males, 13 females; 18 left hemiplegia, 13 right hemiplegia; MACS not reported; GMFCS not reported Intervention group: n = 16; mean age = 58.5 months SD 17.7 months; 8 males, 8 females; 9 left hemiplegia, 7 right hemiplegia; MACS not reported; GMFCS not reported Comparison group: n = 15; mean age = 62.7 months SD 18.0 months; 10 males, 5 females; 4 left hemiplegia, 11 right hemiplegia; MACS not reported; GMFCS not reported |
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| Interventions |
Intervention group (mCIMT) Treatment dosage Length: 4 weeks Duration: 2 hours per session Frequency: 10 sessions over 4 weeks Total dose of therapy time: 20 hours Description Type of restraint device: arm sling Hours per day restraint worn: worn while intervention was given i.e. 2 hours per day for 10 days. An additional home programme was completed with sling for 1 hour per day on intervention days and for 2 hours per day on days with no intervention Treatment environment: clinic and home Individual or group: groups of 4 children Therapy provider: trained occupational therapist and first investigator (discipline unknown). Parents carried out conventional therapy home programme after training by blinded OT. Models of practice: shaping, specific task practice Home programme: “Exercise plan" that involved practice with involved upper limb with restraint of non‐affected upper limb for 1 hour per day, or 2 hours per day on non‐intervention days. Additionally, 20 minutes per day of "conventional" OT home programme was completed and included stretching, strengthening, bimanual hand activities and ADLs Comparison group (low dose) Treatment dosage Length: 4 weeks Duration: 20 minutes Frequency: daily Total dose of therapy time: not reported but calculated as 9.4 hours Treatment environment: home Individual or group: individual Therapy provider: parent Models of practice: not specified Home programme: "Conventional" OT home programme of stretching, strengthening, bimanual hand activities and ADL |
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| Outcomes |
Assessment time points: baseline; 4 weeks from baseline (immediately after intervention);12 weeks from baseline (8 weeks after stopping intervention) (2 weeks to 4 months postintervention) Primary outcome measure
Secondary outcome measures
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| Notes | Median and range data converted to mean and SD using Wan 2014 method Fundings sources: nil mentioned Study author declaration: no declaration provided |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A computer generated random number table was used. Two groups were generated using block randomisation method, using a block size of six" |
| 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: “Allocation to the groups was concealed from the outcome assessor”. " Evaluation was done by a separate physical therapist masked to the group assignment” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “One patient in mCIMT group received five sessions of supervised intervention but did not return for the scheduled visit thereafter”. “The primary analysis was intention to treat. For missing values of outcome measures we carried forward the last observations” Comment: rates of attrition were low, balanced across groups and are unlikely to affect outcomes |
| Selective reporting (reporting bias) | High risk | Comment: Trial was registered in Clinical Trials Registry of India. Register stated one of the outcomes was: quote “To assess parent's perception of improvement in upper extremity function after four weeks of therapy and eight week follow up, using parent questionnaire.” No parent perception data were reported |