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. 2017 May 10;2017(5):CD006185. doi: 10.1002/14651858.CD006185.pub4

Morone 2011.

Methods RCT
 Method of randomisation: by computer program
 Blinding of outcome assessors: stated as 'yes'
 Adverse events: control group 4, experimental group 3
 Deaths: none
 Dropouts: (defined in this study as discontinued intervention) 12 in robotic groups and 9 in control groups
 ITT: yes
Participants Country: Italy
 48 participants (24 in treatment group , 24 in control group )
 All participants were non‐ambulatory at start of study
 Mean age: 62 years
 Inclusion criteria: hemiplegia/hemiparesis in the subacute phase with significant gait deficits (FAC < 3) caused by a first‐ever stroke, lesions that were confirmed by computed tomography or magnetic resonance imaging, and age between 18 and 80 years
Exclusion criteria: presence of subarachnoid haemorrhages, sequelae of prior cerebrovascular accidents or other chronic disabling pathologies, orthopaedic injuries that could impair locomotion, spasticity that limited lower extremity range of motion to less than 80%, sacral skin lesions, MMSE score < 24, and hemispatial neglect, as evaluated by a neuropsychologist
Interventions 2 arms (including strata for motor function):
  • After first week post‐admission, participants performed 20 robotic sessions (5 times per week for 4 weeks) instead of a second session of standard physiotherapy. These sessions lasted 40 minutes, 20 of which consisted of active gait‐training therapy (the remaining 20 minutes were allocated for the participant's preparation, parameter setting, and rest breaks as needed)

  • After first week of admission, participants performed 2 daily physiotherapy sessions. One session was dedicated to walking training, consisting of 20 sessions of 40‐minute therapy (5 times per week), instead of a second session of standard physiotherapy. In light of the participant's ability, the walking therapy was focused on trunk stabilisation, weight transfer to the paretic leg, and walking between parallel bars or on the ground. If necessary, the participant was helped by 1 or 2 therapists and walking aids


The standard physiotherapy, shared by both groups, was focused on facilitation of movement on the paretic side and upper limb exercises, as well as improving balance, standing, sitting, and transferring.
Outcomes Outcomes were recorded by a physician who was blinded to the treatment at baseline, after 4 weeks of the intervention, and at hospital discharge:
  • Primary outcome: walking ability (as measured by FAC)

  • Secondary outcomes: assessments of mobility function and ability level, evaluated by lower‐leg Ashworth (sum of scores for hip, knee, and ankle), Rivermead Mobility Index, Motricity Index, Trunk Control Test, Canadian Neurological Scale, Barthel Index, Rankin Scale, 6‐minute walk test on a 20‐metre path and 10‐metre walk test at a self selected speed

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Generated electronically by www.random.org
Allocation concealment (selection bias) Low risk Central allocation
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Yes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT done; missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.