Methods |
RCT, standard treatment and discussion with therapist versus standard treatment and thermal stimulation |
Participants |
Country: Taiwan Setting: inpatient rehabilitation center 29 participants 1 month post stroke Age: experimental group: mean 58.5 years (SD 12.9), control group mean 59.6 years (SD 12.0) Gender: experimental group 6 males, 9 females; control group 10 males, 4 females Inclusion criteria: first ever stroke less than 1 month ago, no cardiac or orthopedic problem prior to stroke, no cognitive impairment that impairs ability to follow directions, motor deficit of the upper limb under Brunnstrom stage IV Exclusion criteria: diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy, speech disorder or global aphasia |
Interventions |
Intervention group: thermal stimulation program (stimulation, stimulus detection, arm withdrawal) 30 minutes daily 5 times per week for 6 weeks plus standard therapy Control group: 15 to 20 minutes 3 to 5 times per week for 6 weeks reviewing progress with therapist plus standard therapy |
Outcomes |
Outcome measures: assessed weekly starting at baseline until intervention completed Brunnstrom stage Modified Motor Assessment Scale Grasp strength Wrist extension Wrist flexion Sensation by monofilament Tone with Ashworth Scale |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Quote: "Randomization was by computer‐generated random numbers held in sealed envelopes by an individual not involved in the study." |
Allocation concealment? |
Low risk |
Quote: "Randomization was by computer‐generated random numbers held in sealed envelopes by an individual not involved in the study." |
Blinding? All outcomes |
Low risk |
Quote: "The outcome measures were assessed weekly by the same physical and occupational therapists who were blinded to the group of subjects." Comment: authors state in discussion that it was not feasible to blind patients to treatment allocation; it would also not be possible to blind therapists |
Incomplete outcome data addressed? All outcomes |
Low risk |
Quote: "46 patients ... initially enrolled in the study. Twenty‐nine subjects completed the treatment protocol ... Seventeen patients did not finish the experiment because of discharge from hospital, pulmonary infection, transfer to home‐care settings, or searching alternative Chinese medicine therapy." Comment: large percentage of patients lost to follow‐up (37%) and small sample size put study at risk for type II error (authors cite this as potential limitation in Discussion section) |
Free of selective reporting? |
Low risk |
Comment: text, graphs, and tables include all outcome measures |
Free of other bias? |
Low risk |
Comment: potential limitations discussed in the study |