Souza 2015.

Methods	Design: randomised trial of CIMT partly supervised by a caregiver vs CIMT supervised by a therapist Study duration: 6 months (22 days' intervention and 6 months' follow‐up) Randomisation: patients were randomised by a staff member not involved in the study. Randomisation information was stored in sealed envelopes that were kept in a cabinet accessible solely to the principal investigator. Allocation concealment: yes, by the sealed envelopes Blinding: assessor blinded for group allocation ITT: no
Participants	Randomised: 24 participants Withdrawals: 3 participants in the intervention group withdrew because of fatal recurrent stroke, moving away, and financial limitations; 2 participants in the control group withdrew because of returning to work and finding the exercises too difficult. Intervention: 9 participants; 6 men and 3 women; mean age 61.7 years (SD 12.7); time since stroke 27.6 months (20.9) Control: 10 participants; 9 men and 1 women; mean age 59.5 years (SD 9.1); time since stroke 35.3 months (SD 33.8) Inclusion criteria: aged > 18 years; history of ischaemic or haemorrhagic stroke leading to upper limb paresis in the previous 24 months; minimal active range of motion of 10° for wrist extension, 10° for abduction/extension of the thumb and at least 2 additional digits, 90° for shoulder flexion and abduction, 45° for shoulder external rotation, 30° for elbow extension, 45° for forearm supination and pronation (from neutral position), wrist extension (from neutral), and finger extension of all digits; amount‐of‐use score on the Motor Activity Log > 2.5; balance and stability to move using a glove in the unaffected hand; safe and independent transfer to toilet; ability to stand for 2 minutes with and without the glove (with support of upper limbs, if necessary); availability of a family member to supervise home exercises Exclusion criteria: medical problems or cognitive deficit (Mini‐Mental State Examination score < 24) that could interfere with study completion; aphasia or hemi‐neglect; intended or actual participation in any other study; significant pain (≥ 4 on a visual analogue scale) in any joint; upper limb treatment with antispasticity drugs in the previous 6 months; and severe upper limb spasticity (≥ 3 in the Modified Ashworth Scale)
Interventions	Intervention: in the CIMT1.5h_direct group, patients performed exercises with the paretic upper limb for 1.5 hours at an outpatient facility and home exercises, supervised by a caregiver or family member, for additional 1.5 hours. 2 days before treatment started, the caregiver was trained for 1 hour by the researcher providing CIMT on how to supervise the prescribed exercises performed by the patient at home. Each caregiver was instructed to make notes in a log book about the exercises performed, the number of repetitions, and difficulties experienced by the patient. At the beginning of each session, the homework was discussed and when necessary, the level of difficulty was increased or new tasks were prescribed. The CIMT1.5h_direct group received written assignment of practice at home. Control: in the CIMT3h_direct group, patients performed exercises under direct supervision of a therapist, at the outpatient facility, In both groups , training was provided in an individual basis and consisted of shaping principles and task‐specific practice. Shaping exercises comprised a battery of tasks including grasping and releasing objects of different shapes, playing cards and board games, clay activities, drawing, and painting. Tasks were tailored to needs of each patient. Task‐specific practice for both groups involved preparing a snack (sandwiches and juice), including arranging dishes and cutlery on a table, washing and drying them, and putting them in a cupboard. Treatment regimens were designed to ensure that both groups received the same amount of task practice and shaping. Furthermore, in both groups, patients were required to use a padded mitt in the unaffected hand at home, as much as possible during waking hours. The mitt prevented use of the unaffected hand to perform fine motor activities and was used during ADL and household activities. All patients were instructed to record the use time of the mitt and any difficulties perceived at home, in log books. At the beginning of each outpatient session the notes were discussed and, if necessary, problem‐solving strategies were applied. Setting: at home and an outpatient clinic
Outcomes	Included outcomes: Motor Activity Log ‐ quality of movement, Fugl‐Meyer Assessment upper extremity scale, Stroke Specific Quality of Life Scale Measurements: baseline, post intervention 2 days after stop of the intervention, and follow‐up 6 months after post intervention assessment
Notes	No means and SDs were published of post intervention or follow‐up scores, but effectiveness indexes were. However, contact with the authors was unsuccessful. Stroke leading to upper limb paresis in the previous 24 months was named as an inclusion criterion. However, mean time after stroke was 27 months in the intervention group and 35 months in the control group.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomised by a staff member not involved in the study". But not described how
Allocation concealment (selection bias)	Low risk	Used sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel cannot be blind for the intervention.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessor blinded for group allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	5 withdrawals: 2 in control group and 3 in intervention group. Reasons were well described and similar
Selective reporting (reporting bias)	Unclear risk	No trial registry; nothing stated
Other bias	Unclear risk	No ITT No means and SDs were described