Thaut 2007.
Study characteristics | ||
Methods | Study design: RCT Method of randomisation: "2 research centers in Germany and the United States were selected by a random number table. Patients were randomly assigned to either the experimental (RAS; n = 43; male = 22, female = 21) or control (neurodevelopmental technique/Bobath; n = 35; male = 19, female = 16) training group (see Table 1). Treatment allocation was accomplished by computerized random number generators in both centers" |
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Participants | Number of participants: n = 78 Inclusion criteria: not stated ("from an eligible catchment pool of 155 patients") "Patients entered the study within 4 weeks of onset, as soon as they could complete 5 stride cycles with handheld assistance by the therapist, that is, with no more than support of the forearm, wrist, and elbow at approximately 90 degrees of elbow flexion on the nonparetic side. Handheld assistance was available to all patients throughout training when needed" |
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Interventions | (1) Rhythmic auditory stimulation (n = 43) "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. After an initial cadence assessment, cuing frequencies were matched to the gait cadence for the first quarter of the session. During the second quarter, cue frequencies were increased in 5% increments as kinematically indicated without compromising postural and dynamic stability. During the third quarter, adaptive gait patterns, for example, ramp or step walking, were practiced. The last quarter was spent fading the cues intermittently to train for independent carryover" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising functional task training Length of intervention period: three weeks Number of sessions and length of individual sessions: "gait training daily for 30 minutes, 5 times per week" Intervention provider: "Four gait therapists for each group conducted the training to ensure consistency in training protocols and procedures. Each center had its own independently trained pool of therapists" (2) Neurodevelopmental therapy (NDT)/Bobath‐based training (n = 35) "control group trained the same amount of time and distance, following NDT and Bobath principles as well as using similar instructions about gait parameters to practice, but without rhythmic auditory cuing" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising functional task training and neurophysiological intervention Length of intervention period: three weeks Number of sessions and length of individual sessions: "gait training daily for 30 minutes, 5 times per week" Intervention provider: "Four gait therapists for each group conducted the training to ensure consistency in training protocols and procedures. Each center had its own independently trained pool of therapists" This study is classified as active intervention one (functional task training) versus active intervention two (functional task training, neurophysiological) (Table 9) |
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Outcomes | Measures of independence in ADL: Barthel Index Measures of motor function: Fugl‐Meyer Assessment Measures of voluntary movement: gait velocity, stride length, cadence and symmetry Time points when outcomes were assessed: "All patients were tested 1 day before the training sessions started and 1 day after the last training session" |
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Notes | "All available participant data after removing dropout participants were analyzed in an intention‐to‐treat analysis" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "selected by a random number table" |
Allocation concealment (selection bias) | Low risk | "Treatment allocation was accomplished by computerized random number generators in both centers. Random numbers for the allocation‐to‐treatment sequence were concealed from the recruiter and the therapists carrying out the training. Patients were informed of the 2 possible treatment allocations but blinded to the aims of an experimental versus control condition" "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" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Both groups were assessed by blinded physical therapists" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts accounted for "Dropout rate in one center was 23% of initially included patients. There was a 10% dropout rate in the other center. Dropout reasons were due to hospital transfer, early discharge, medical complication, or unspecified personal reasons" |
Free of systematic differences in baseline characteristics of groups compared? | Low risk | "Lesion site was closely matched in both groups. Mild to moderate sensory dysfunction was present in all middle cerebral artery distribution strokes. Both groups had lower limb spasticity, most pronounced in knee flexors/extensors, plantar flexion, and hip flexors/extensors, as typical for a stage 4 or early stage 3 on the Brunnstrom hemiplegia recovery scale" |
Did authors adjust for baseline differences in their analyses? | Low risk | No information provided |
Other bias | Unclear risk | No information provided |