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. 2016 Mar 24;2016(3):CD003316. doi: 10.1002/14651858.CD003316.pub6

Letombe 2010

Methods Design: randomised trial of mixed training plus usual care versus usual care Randomisation: information not included Allocation concealment: information not included Blinding: information not included ITT: not completed Measurements: before and end of intervention (4 weeks) Withdrawals: none reported
Participants Randomised: total 18 participants: 9 participants were randomised to intervention, 9 to control Intervention: 9 participants; 5 males, 4 females; mean age: (combined males and females) 59.1 years (SD 9.4); mean height: unknown; mean weight: unknown; type of stroke: ischaemic 5, haemorrhagic 4; paretic side: right 4, left 5; time since stroke onset: 20 days Control: 9 participants; 6 males, 3 females: mean age: (combined males and females) 60.6 years (SD 8.2); mean height: unknown; mean weight: unknown; type of stroke: ischaemic 5, haemorrhagic 4; paretic side: right 4, left 5; time since stroke onset: 20 days Inclusion criteria: right or left hemiplegia following ischaemic or haemorrhagic hemispheric stroke; a full set of aetiological data (CT and/or MRI scans, Holter ECG, Doppler, cardiac ultrasound); a stable clinical state; well‐balanced treatment (particular in terms of antihypertensives and anticoagulants)
Exclusion criteria: existence of disorders associated with hemiplegic motor damage, such as cognitive and memory disorders; hemisensory neglect; the existence of an intercurrent affection or unstable brain lesions
Interventions Intervention: participants in the training group (n = 9) received conservative physical therapy for 3 hours per day, 5 days per week, for a period of 4 weeks. Conservative physical therapy consisted of gait exercises, stance exercises, the treatment of orthopaedic disorders, balance work (with a view to subsequently withdrawing gait aids), use of support stockings and braces and maintenance of the freedom of movement of the proximal‐distal limb joints. In addition general exercise training was implemented, with cardiorespiratory exercise (monitored by a heart rate monitor), muscle strengthening, gait exercises, and work focused on executive functions, lasting for between 40 and 60 minutes per day, 4 times a week. Aerobic exercise was included in the form of steady exercise on a semi‐recumbent cycle ergometer (with both feet pedalling) was performed at between 70% and 80% of maximum power
Control: Participants in the control group (n = 9) received conservative physical therapy for 3 hours per day, 5 days per week, for a period of 4 weeks. Conservative physical therapy consisted of gait exercises, stance exercises, the treatment of orthopaedic disorders, balance work (with a view to subsequently withdrawing gait aids), use of support stockings and braces and maintenance of the freedom of movement of the proximal‐distal limb joints
Setting: hospital setting
Outcomes Included outcomes: triangular maximal aerobic power test using a cycle ergometer
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described only as "randomized into two groups"
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) All outcomes High risk Not reported; not attention control
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) End of intervention Low risk ITT not reported
No participant losses
Selective reporting (reporting bias) High risk Trial register or protocol not available
Other bias Unclear risk Unclear
Imbalanced exposure High risk Imbalanced exposure