Taub 2011.
| Methods |
Design: single‐centre randomised controlled trial with cross‐over Comparison groups reported by study authors: CIMT vs usual care Country: USA 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) Stroke in prenatal, perinatal or very early antenatal period confirmed by MRI (b) Congenital hemiparesis (c) Aged 2 to 6 years (d) No serious or recurring medical complications (e) Living within 40 miles of clinic or willing to temporarily locate to the area Exclusion criteria (a) Score of > 2.5 on the Pediatric Motor Activity Log for the more affected limb (b) Uncontrolled seizures (c) Botulinum toxin‐A injection in the upper limb or other spasticity medications within 3 months of intervention (d) Fixed contractures in the upper limb (4 or more on the Ashworth scale) (e) Previous CIMT or forced use therapy Participants: 22 children with congenital hemiparesis Randomisation method: children were assigned randomly in blocks of 4 ‐ no further details provided Dropouts: n = 2: comparison n = 2 (dropped out prior to intervention, n = 1 seizures, n = 1 indefinite hospitalisation) Number of participants who received intended treatment: n = 20 (91%): intervention n = 10, comparison n = 10 Number of participants who were analysed: total sample: n = 20; mean age = 3.65 years SD 1.42 years (calculated by review authors); 4 males, 16 females; 6 left hemiplegia, 14 right hemiplegia; MACS not reported; GMFCS not reported Intervention group: n = 10; mean age = 4 years SD 1.2 years; 2 males, 8 females; 2 left hemiplegia, 8 right hemiplegia; MACS not reported; GMFCS not reported Comparison group: n = 10; mean age = 3.3 years SD 1.6 years; 2 males, 8 females; 4 left hemiplegia, 6 right hemiplegia; MACS not reported; GMFCS not reported |
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| Interventions |
Intervention group (hybrid CIMT) Treatment dosage Length: 3 weeks (15 consecutive weekdays) ‐ 13 days of CIMT and 2 days of bimanual activities Duration: 6 hours per day Frequency: each week day Total dose of therapy time: 90 hours Description Type of restraint device: long arm cast including hand and fingers to above elbow (univalved for skin check only) Hours per day restraint worn: 24 hours Treatment environment: home and community Individual or group: individual Therapy provider: a therapist (profession unspecified) Models of practice: shaping ‐ the more affected arm was trained intensively by a behavioral procedure termed ‘‘shaping ‐ where the child is required to improve performance, usually in small steps, at each iteration of a movement to obtain a reward (enthusiastic praise, encouraging exclamations, and other signs of approval by the therapist)" At the beginning of the fourteenth day of treatment, the cast was removed and the child received training in using the more affected arm in bilateral activities for the final 2 days of treatment Throughout, a ‘‘transfer package,’’ was used to induce transfer of therapeutic gains from the treatment period to usual life activities Home programme: written list of training tasks given to caregiver to complete over weekends. Caregivers were trained in the shaping of movements.Home programme provided post treatment to encourage continuation of training – weekly phone calls from therapist carried out for first month post treatment Comparison group (low dose) Length: 3 weeks (although can presume they continued for the 6‐month control period) Duration: 1‐2 hours Frequency: 1‐2 sessions per week Total dose of therapy time: not reported Description Treatment environment: not specified Individual or group: not specified Therapy provider: occupational therapist or physiotherapist Models of practice: not stated Home programme: not stated |
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| Outcomes | Assessment time points: baseline. PMAL collected daily during treatment. Immediately following intervention (following 15 weekdays of treatment); 4 weeks post baseline; 6 months post baseline (2 weeks to 4 months postintervention) Primary outcome measure
Outcome measures
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| Notes |
Additional information sought from authors: authors contacted but declined to provide MAS data and PAFT data (to enable pooling with a second study) Fundings sources: National Institutes of Health (5R13NS040925‐09), the National Institutes of Health Office of Rare Diseases Research, the Child NeurologySociety, and the Children’s Hemiplegia and Stroke Association, Grant HD040692 from the National Center for Medical Rehabilitation Research of NICHD. Study author declaration: the authors declared no potential conflicts of interest with respect to the authorship and/or publication of this article |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Children were assigned randomly in blocks of 4" Comment: insufficient information given to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described. 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 PMAL was not possible |
| Blinding of outcome assessment (detection bias) Objectively observed outcomes | Unclear risk | Comment: not described. Insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Two children assigned to the control group dropped out before treatment began, 1 because of a seizure and 1 because of an indefinite hospitalization" Comment: amount of, and reasons for, missing data is not 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 judgement |