Thaut 2007.
Methods | RCT 2‐arm parallel‐group design | |
Participants | Participants with subacute hemiparetic stroke Diagnosis: 65 (83%) middle cerebral artery stroke; 8 (11%) internal capsule stroke; 4 (5%) basal ganglia/thalamus stroke; 1 (1%) subdural haematoma Time since onset: approximately 21 days N randomised to experimental group: 43 N randomised to control group: 35 N analysed in experimental group: 43 N analysed in control group: 35 Mean age: 69.2 years (SD 11.5) experimental group; 69.7 years (SD 11.2) control group Sex: 37 (47%) female, 41 (53%) male Ethnicity: not reported Setting: 2 research centres Country: USA and Germany |
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Interventions | 2 study groups: 1. Music intervention group: RAS 2. Control group: standard neurodevelopmental therapy/Bobath Number of sessions: 15 sessions in total, once daily for 5 days over 3 weeks Length of sessions: 30 minutes |
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Outcomes | Gait parameters: velocity, stride length, cadence, symmetry: post‐test scores were used Participant satisfaction with treatment: F statistic and P values used | |
Notes | The RAS employed in this study used metronome beat in combination with recorded music. Quote: "RAS training followed established protocols using a metronome and specifically prepared music tapes in digital MIDI format to ensure temporal precision and tempo stability as well as full capacity for frequency modulation of the stimulus based on patient needs" (p456) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers |
Allocation concealment (selection bias) | Low risk | Serially numbered, opaque, sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | It is not possible to blind participants receiving RAS or the personnel involved in delivering RAS. Quote: "Therapists were not blinded to the treatment conditions of the study. However, because both conditions are considered full treatment conditions, no performance bias was expected." (p456) |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Subjective outcomes included participant satisfaction, however the measures used and the methods of data collection were not reported |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: “Both groups were assessed by blinded physical therapists” (p456) |
Incomplete outcome data (attrition bias) All outcomes | High risk | 23% dropouts in German centre, 10% in US centre (absolute numbers are not reported) Reasons: hospital transfer, early discharge, medical complications, unspecified personal reasons |
Selective reporting (reporting bias) | Low risk | There are no indications of selective reporting for this study |
Free from financial conflict of interest | Low risk | No funding support was reported |