Hosseini 2010.
| Methods |
Design: single‐blind, randomised controlled trial Comparison groups reported by study authors: CIMT vs conventional therapy Country: Iran 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) Ability to extend wrist joint more than 20° and fingers in metacarpophalangeal joints at least 10° from full flexion (b) More than 50% difference between involved and non‐involved hands in Jebson Taylor Test of Hand Function (c) Ability to raise involved hand from surface of table more than 15 centimetres (d) Score of at least 70 on Color Raven Test of IQ (e) Willingness to participate in the research Exclusion criteria (a) Health difficulties not related to CP (b) Treatment‐resistant seizures (c) Visual problems that would interfere with carrying out the test (d) Modified Ashworth Score average score greater than 3.5 in upper limbs (e) Orthopaedic surgery on involved hand (f) Rhizotomy in the last year (g) Botulinum toxin treatment in muscles of upper limbs in the last six months or during the study (h) Use of intrathecal baclofen in the six months before intervention or during the study (i) Balance problems while wearing splint Participants: 28 children with unilateral CP were recruited and allocated equally to groups Randomisation method: “Participants have been selected based on stratified random sampling method. In this method, after providing sampling framework, persons based on inclusion and exclusion criteria have been classified in 4 levels, then samples has been selected randomly in two groups.” (p.51). No additional information was reported Dropouts: intervention n = 2, comparison n = 1 (reasons were beginning of school season and length of sessions every day; reasons per group were not given) Number of participants who received intended treatment: intervention n = 12, comparison n = 13 Number of participants who were analysed: total sample: n = 25; mean age = 7 years 5 months SD 5 years 4 months, range = not reported; 13 males, 12 females; 15 left hemiplegia, 10 right hemiplegia; MACS: not reported; GMFCS: not reported Intervention group: n = 12; mean age = 7 years 10 months SD 7 years 6 months; 6 males, 6 females; 8 left hemiplegia, 4 right hemiplegia; MACS: not reported; GMFCS: not reported Comparison group: n = 13; mean age = 7 years 10 months SD 1 years 5 months; 7 males, 6 females; 7 left hemiplegia, 6 right hemiplegia; MACS: not reported; GMFCS: not reported |
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| Interventions |
Intervention Group (mCIMT) Treatment dosage Length: 10 days Duration: 6 hours per day Frequency: 10 days Total dose of therapy time: face‐to‐face time with therapist = 60 hours Description Type of restraint device: splint Hours per day restraint worn: not reported Treatment environment: not reported Individual or group: not reported Therapy providers: not reported Models of practice: not reported Home programme: not reported Comparison Group (low dose) Treatment dosage Length: unclear Duration: unclear Frequency: unclear Total dose of therapy time: unclear Description Treatment environment: not reported Individual or group: not reported Therapy provider: not reported Models of practice: NDT Home programme: not reported |
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| Outcomes |
Assessment time points: baseline; 2 weeks (Immediately postintervention) Primary outcome measures
No information on scoring/measurement units or direction and magnitude of scales were provided Hand‐grip strength using handheld goniometer Passive range of motion – muscle groups not specified Modified Ashworth Scale – muscle groups not specified Two‐point discrimination Bruininks‐Oseretsky Test of Motor Proficiency – subscales used were: Manual Dexterity with non‐involved and involved hands separately, Bilateral Coordination, Upper‐Limb Coordination. Reason for exclusion: No established reliability or validity in CP Jebsen Taylor Hand Function Test. Reason for exclusion: No established reliability or validity in CP Active range of motion – muscle groups not specified. Reason for exclusion: No established reliability or validity in CP Caregiver Functional Use Survey. Reason for exclusion: No established reliability or validity in CP Unimanual function composite (for involved and uninvolved hands separately) – composite scores from Manual Dexterity and Jebsen Taylor Hand Function Test. Reason for exclusion: No established reliability or validity in CP Bimanual Function composite – composite score from Bilateral Coordination, Upper‐Limb Coordination and Caregiver. Reason for exclusion: No established reliability or validity in CPFunctional Use Survey. Reason for exclusion: No established reliability or validity in CP |
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| Notes |
Additional information sought from authors: letter emailed to corresponding author at: soortigi.ot@gmail.com on 22/7/2016 and reminder on 21/8/2016. No response from authors. No data available for inclusion in the review Fundings sources: Pediatric Neurorehabilitation Center of University of Social Welfare and Rehabilitation Sciences Study author declaration: no declaration given |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Participants have been selected based on stratified random sampling method. In this method, after providing sampling framework, persons based on inclusion and exclusion criteria have been classified in 4 levels, then samples has been selected randomly in two groups”. Page 51 Comment:the authors do not report the nature of the strata nor any further details of the methods used to generate the allocation sequence. Insufficient information to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Quote: “Participants have been selected based on stratified random sampling method. In this method, after providing sampling framework, persons based on inclusion and exclusion criteria have been classified in 4 levels, then samples has been selected randomly in two groups.” Page 51 Quote: “Finally, randomly the participants were placed in constraint induced movement therapy and conventional therapy groups”. Comment: not described. Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “This research has been performed with single blinded, randomized, control trial” page 51 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 | Unclear risk | Quote: “This research has been performed with single blinded, randomized, control trial…” page 51 Comment: not described. Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “…due to beginning school season and being too long session in every day, 3 children failed (2 children in CIMT and 1 in conventional group).” Page 51 Comment: three of 28 children dropped out of intervention and therefore were not included in the analysis (89% completed). Reason for missing outcome data are unlikely to be related to true outcome and numbers were balanced across groups Completion of an intention‐to‐treat analysis was not specified |
| Selective reporting (reporting bias) | High risk | Comment: no study protocol located. Results for some of the measures specified in the paper were not reported |