Methods | Assessor‐blind RCT | |
Participants | Country: Australia 40 participants randomized to 2 groups of 20 Mean age: 68 years 57% female 100% right‐side dominant 57% right‐side CVA Mean 5 days post stroke Inclusion criteria: within 2 weeks of first ischemic stroke as documented with CT Exclusion criteria: previous stroke, trauma affecting the upper limbs, vision and hearing deficits, unable to sit in a chair for 1 hour, MMSE < 22/30, major comorbidities | |
Interventions | 14 days with 20 to 30 minutes mirror or sham therapy and 1 to 2 hours 5 times per week of therapy as usual Intervention group: mirror therapy plus therapy as normal; completed sensory motor tasks inside mirror box that provided visual feedback of bilateral simulataneous hand movements Control group: sham therapy plus therapy as normal; completed sensory motor tasks inside sham box with no mirror providing visual feedback of unilateral activity Sensory motor tasks included: grip strengthening tasks, AROM, sensory discrimination tasks, functional hand tasks | |
Outcomes | Blinded assessors with observations recorded at baseline, and post intervention (2 weeks and 6 weeks from baseline) Synchiria Pain Quanitative Sensory Test (light touch, punctate touch, thermal and pressure pain thresholds) Affected hand grip strength Motor Assessment Scale: upper limb portion | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Quote: "Recruited participants firstly underwent the upper limb sensorimotor assessment. Afterwards, patients were randomised into two groups with a computer‐generated randomisation." |
Allocation concealment? | Low risk | Quote: "Randomisation was performed by an independent investigator and was concealed from the investigator at a remote site." |
Blinding? All outcomes | Low risk | Participants not blinded even though attempts were made to reduce differences in expectation Quote: "The investigator was made aware of the patient‐group on the first day of treatment by telephone or email. Participants knew which group they were in but were under the impression that both mirror and sham therapy were expected to generate similar outcomes. Assessors were blinded. Post‐treatment outcome measures were taken by one of two experienced physiotherapists with at least five years of clinical stroke experience ... Post‐treatment outcome measures were performed by the same assessors who were blinded to the experimental group; outcome measures were taken after the intervention (i.e. after two weeks of treatment)" |
Incomplete outcome data addressed? All outcomes | Low risk | All participants and data accounted for |
Free of selective reporting? | Low risk | The thesis details all pre‐planned outcomes |
Free of other bias? | Low risk | None noted |
ADL: activities of daily living AROM: active range of motion CT: computerized tomography CVA: cerebrovascular accident IADL: instrumental activities of daily living MMSE: Mini Mental State Examination RCT: randomized controlled trial SD: standard deviation