Lin 2009a
Methods | Randomised controlled trial using a stratified block allocation scheme Computerised (block) randomisation, with pre‐stratification according to participating hospital Allocation concealment ensured by use of opaque, numbered envelopes (each hospital site had a pre‐prepared set of envelopes with cards indicating allocation) | |
Participants | 60 participants Inclusion criteria: > 6 months post CVA, > Stage III Brunnstrom stage for proximal and distal parts of upper limb, considerable non‐use of the affected upper limb (Motor activity log, amount of use < 2.5), no serious cognitive deficits (≥ 24 on MMSE), no excessive spasticity in any joints of upper limb (Modified Ashworth Scale ≤ 2), lack of participation in any experimental rehabilitation or drug study within past 6 months, no balance problems sufficient to compromise safety when wearing constraint mitt | |
Interventions | Group 1 (20 participants): usual care ‐ training for hand function, co‐ordination, balance and movements of the affected upper limb and compensatory practice with affected or both upper limbs Group 2 (20 participants): other upper limb intervention ‐ constraint‐induced therapy: restriction of movement of the unaffected hand by placement in a mitt for 6 hours/day and intensive training of the affected upper limb in functional tasks; level of ability adapted based on patient ability and improvement during training Group 3 (20 participants): bilateral training ‐ simultaneous movements of both affected and unaffected upper limb in functional tasks in symmetric or alternating patterns All groups completed therapy for 2 hours/day, 5 days per week for 3 weeks All other interdisciplinary rehabilitation continued Occupational therapists undertook the training in each group | |
Outcomes | Primary outcome: performance in activities of daily living: Functional Independence Measure Primary outcome: functional movement ‐ Motor Activity Log: amount of use and quality of movement scales (amount of use scale selected); Stroke Impact Scale ‐ hand function section Secondary outcome: performance in extended activities of daily living: Stroke Impact Scale (ADL/IADL section); motor impairment ‐ motor impairment scales: Fugl‐Meyer scale | |
Notes | Overall and sub‐scores for the Fugl‐Meyer and Functional Independence measure were presented We only entered the overall scores into the data analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | Opaque, numbered envelopes |
Blinding of outcome assessor? | Low risk | Occupational therapists blinded to group assignment completed outcome assessments |
Intention to treat analysis? | Unclear risk | Not reported; no drop‐outs from study |
Baseline similarity | Low risk | No significant differences between groups in terms of demographic and clinical characteristics |