4. Adverse events.
Study | Adverse events |
CIMT versus low‐dose comparison | |
Abootalebi 2010 | The study did not mention the presence or absence of adverse events. |
Al‐Oraibi 2011 | The study did not mention the presence or absence of adverse events. |
Charles 2006 | One child who was unable to tolerate CIMT was removed from study. |
Choudhary 2013 | The study did not mention the presence or absence of adverse events. The study reported that the children tolerated the treatment well. |
de Brito Brandão 2010 | The study did not mention the presence or absence of adverse events. |
Dong 2017 | The study reported that “No major adverse events were reported” (p 4), however, “There were two dropouts from the CIMT group in the first week of treatment, because the children did not tolerate the intervention and complained about inconvenience during physical activities at school” (p 4). |
Eliasson 2011 | One child was unable to tolerate CIMT. |
Eliasson 2018 | The study reported that there were no adverse events. |
Eugster‐Buesch 2012 | The study reported there were no adverse events to the affected hand. Parent questionnaire reported the CIMT program caused frustration in completing activities (2/11), splint refusal was observed (6/11) and completing the programme was exhausting (6/11) |
Facchin 2011 | The published trial protocol (Facchin 2009) specified that the unaffected limb would be monitored using Quality of Upper Extremity Skills Test (QUEST) and Besta Scales. The study reported no significant or sustained, long‐term adverse effects for the unaffected limb. Facchin 2009 also specified that behaviour change would be assessed using the Child Behaviour Checklist and family stress would be monitored using Parenting Stress Index but no data were provided for either of these outcomes at any time point. |
Gharib 2010 | The study did not mention the presence or absence of adverse events. |
Hosseini 2010 | The study did not mention the presence or absence of adverse events. |
Rostami 2012b | The study did not mention the presence or absence of adverse events. |
Sabour 2012 | The study did not mention the presence or absence of adverse events. |
Taub 2004 | The study reported that all children adapted to CIMT within 1 to 2 days. The study also reported that 2 children in CIMT group with a history of behaviour management problems experienced behaviour control difficulties, and that 3 (DeLuca 2006) or 4 (Taub 2004) children in CIMT group experienced minor and reversible skin irritations from casting. All children maintained full range of movement and functional movement skills in the arm that had a cast applied. |
Taub 2011 | The study reported that the children generally coped well with the cast, with few complaints after the first day. |
Yu 2012 | The study did not mention the presence or absence of adverse events. |
CIMT versus high‐dose comparison | |
Chen 2014 | The study reported that there were no adverse events bu that “some children experienced frustration in the early stages of constraint‐induced therapy”. |
Hoare 2013 | The study reported there were no adverse events resulting from CIMT. |
Sakzewski 2015a | The study reported that 1 child in the hybrid‐CIMT group had a seizure, which was unrelated to the intervention. |
Wallen 2011 | The study reported minor adverse events in 5 children in the CIMT group due to a lack of acceptance of the CIMT mitt and frustration/refusal to co‐operate. The study reported there were no adverse events due to the comparison intervention. |
CIMT versus dose‐matched comparison | |
Aarts 2010 | The study reported that there were no adverse events. |
Abd El‐Kafy 2014 | The study did not mention the presence or absence of adverse events. |
Deppe 2013 | The study did not mention the presence or absence of adverse events. |
Dong 2017 | The study reported that “No major adverse events were reported” (p 4), but that “There were two dropouts from the CIMT group in the first week of treatment, because the children did not tolerate the intervention and complained about inconvenience during physical activities at school” (p 4). |
Facchin 2011 | The published trial protocol (Facchin 2009) specified that the unaffected limb would be monitored using QUEST and Besta Scales. They reported no significant or sustained, long‐term adverse effects for the unaffected limb. Facchin 2009 also specified that behaviour change would be assessed using the Child Behaviour Checklist and family stress would be monitored using Parenting Stress Index, however, no data were provided for either of these outcomes at any time point. |
Gelkop 2015 | The study reported that there were no adverse events. |
Gordon 2011 | The study reported that there were no adverse events. |
Kirton 2016a (CIMT + r TMS); Kirton 2016b (CIMT + sham TMS) | The study authors reported that all participants completed all stages with no dropouts or adverse events. Also, although headache was reported in 11% of repetitive Transcranial Magnetic Stimulation (rTMS) group, it was mild and self‐limiting. Additional side effects (tingling, nausea) were reported in < 3% of sessions. |
Rostami 2012b | The study did not mention the presence or absence of adverse events. |
Sakzewski 2011 | The study reported that there were no “major” adverse events. |
Sakzewski 2015b | The study did not mention the presence or absence of adverse events. |
Smania 2009 | The study authors stated that one child was excluded following commencement of Modified CIMT (mCIMT) due to behaviour difficulties manifesting on commencement of mCIMT. The parents of 3 children reported resistance to wearing the mitten for the first few days. |
Sung 2005 | The study reported no decline in hand function of the immobilized unaffected arm after 6 weeks in the forced‐use therapy group, or any cases of joint stiffness or skin problems. |
Xu 2012 | The study reported that there were no adverse events. |
Zafer 2016 | The study did not mention the presence or absence of adverse events. |
CIMT versus different form CIMT | |
Christmas 2018 | The study reported that there were no serious adverse events. 12 non‐serious adverse events related to the intervention were identified for the prolonged restraint group: 2 children had minor bruising because of a fall and 10 had small areas of skin abrasions. |
DeLuca 2012 | The study reported that there were no adverse events. |
Rostami 2012a | The study did not mention the presence or absence of adverse events. |
CIMT: constraint‐induced movement therapy.