Abd El‐Kafy 2014.
| Methods |
Design: single‐centre randomised controlled trial Comparison groups reported by study authors: CIMT vs conventional non‐structured therapy programme Country: Egypt Other: no protocol or trial registration identified Groups defined by Cochrane authors
Comparison defined by Cochrane authors and used in meta‐analysis: CIMT vs dose‐matched |
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| Participants |
Inclusion criteria (a) Diagnosis of congenital unilateral CP confirmed by MRI (b) Aged 4 to 8 years (c) MAS 1‐2 in the upper limb (d) MACS Levels II‐IV (e) Ability to extend the wrist a least 20° and fingers 10° from full flexion (f) Cognitively competent and able to follow instructions (g) No serious or recurring medical conditions (h) Not receiving other interventions to improve upper‐limb function Exclusion criteria (a) Visual problems that would prevent child from performing the intervention (b) Balance problems that would put child at risk of falling when wearing a restraint (c) Uncontrolled seizures (d) Botulinum toxin‐A injections to upper limb in last 6 months, or plan to receive it during study period (e) Other muscle tone control medications within three months of pre‐treatment testing (f) Fixed contractures or stiffness in affected upper limb that would limit activity engagement (g) Previous CIMT or forced use therapy (h) Orthopaedic or neurological surgery in upper limb Participants: 30 children with unilateral CP Randomisation method: allocated randomly on computerised basis using SPSS Dropouts: n = 3; intervention n = 1 (inability to continue intervention), comparison n = 2 (n = 1 died, n = 1 travel difficulties) Number of participants who received intended treatment: n = 27 (90%), intervention n = 14, comparison n = 13 Number of participants who were analysed: total sample: n=27; mean age = 6.1 years SD 1.5 years (calculated by review authors); 12 males, 15 females; 3 left hemiplegia, 24 right hemiplegia; MACS not reported; GMFCS not reported Intervention group: n=14; mean age = 6.0 years SD 1.7 years; 7 males, 7 females; 2 left hemiplegia, 12 right hemiplegia; MACS not reported; GMFCS not reported Comparison group: n=13; mean age = 6.2 years SD 1.3 years; 5 males, 8 females; 1 left hemiplegia, 12 right hemiplegia; MACS not reported; GMFCS not reported |
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| Interventions |
Intervention group (CIMT) Treatment dosage Length: 4 weeks Duration: 6 hours per day Frequency: 5 days per week for 4 weeks Total dose of therapy time: 120 hours (planned: 80 in clinic, 40 at home) Description Type of restraint device: sling strapped to the child’s trunk at the distal end and sewn shut Hours per day restraint worn: 6 hours per week day Treatment environment: home and clinic Individual or group: not specified – assume individual Therapy provider: two therapists (OTs and/or PTs) and parents Models of practice: shaping, repetitive practice Home programme: list of treatment activities, including arm reaching, weight‐bearing and strengthening, manipulative, arm‐hand and postural reactions exercises, and upper‐limb self‐care activities. Restraint was worn for home programme. Comparison group (dose‐matched, conventional unstructured therapy programme) Treatment dosage Length: 4 weeks Duration: 6 hours per day Frequency: 5 days per week Total dose of therapy time: 120 hours (planned: 80 in clinic, 40 at home) Treatment environment: clinic and home Individual or group: not specified – assume individual Therapy provider: two therapists (OTs and/or PTs) and parents Models of practice: 'conventional’ therapy Home programme: list of treatment activities, including arm reaching, weight‐bearing and strengthening, manipulative, arm‐hand and postural reactions exercises, and upper‐limb self‐care activities i.e., same as treatment group but without wearing the restraint. |
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| Outcomes |
Pre‐treatment: immediately following intervention, 3 months following end of treatment (2 weeks to 4 months postintervention) Primary outcome measure
Pediatric Arm Functional Test (PAFT) (Uswatte 2012) (% score; range 0 to 100) Quality of Upper Extremity Skills Test (QUEST) ‐ Total score (% score; range 0 to 100). Reason for exclusion: Total score is reported to have poor construct validity (Thorley 2012). Isometric shoulder torque. Reason for exclusion: No evidence of validity or reliability in CP |
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| Notes | No data from this study have been included in this review as the data reported in the manuscript were not able to be included in meta‐analysis. Reported as “mean rank” with unclear analytical procedure Additional information sought from authors: authors have not responded to attempts to contact them requesting change data for eligible outcomes including QUEST and PAFT Fundings sources: nil mentioned Study author declaration: the authors report no conflicts of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The recruited children were allocated randomly on a computerized base using SPSS (version 16) into two equal groups of 15 children each" |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided and therefore unable to make a judgement of either low or high risk of bias |
| 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 PAFT was not possible |
| Blinding of outcome assessment (detection bias) Objectively observed outcomes | Low risk | Quote: "The evaluators (physical therapists and occupational therapist) who performed all assessments throughout the study did not take part in the intervention program. They also had not been informed regarding which group each evaluated child belonged to (blind assessors)" Comment: blinding of outcome assessment assessed to be low risk of bias for PAFT, QUEST, isokinetic muscle strength |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: one child from CIMT group was not included in analysis as the child discontinued intervention due to frustration, attrition therefore due to intervention. Two children from the comparison group were not included in analysis (one died, one had long distance between home and clinic). Rate of follow‐up is high (90%) and attrition is unlikely to affect outcomes. It is unclear whether the reason for attrition in the CIMT is likely to affect outcomes. 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 a judgement of low or high risk |