Brock 2005.
Study characteristics | ||
Methods | Study design: multi‐centre RCT Method of randomisation: "Randomization was done through a computer‐generated, stratified, blocked randomization procedure. Patients were stratified according to time period from date of stroke to date of commencement in the trial. The two strata were four weeks to eight weeks post‐stroke at commencement of the trial and more than eight weeks post‐stroke. This stratification aimed to improve the likelihood of the two groups being similar in terms of initial severity and speed of recovery post‐stroke, as those with milder stroke and a quicker rate of recovery are likely to improve more rapidly during the time period of the study. Separate computer‐generated randomizations were used for each site. Opaque envelopes were used to conceal group allocation. Participants were randomized and assigned to the intervention groups after the baseline assessments were carried out" |
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Participants | Number of participants: n = 26 Inclusion criteria: "first or recurrent stroke, haemorrhage or infarct, between four weeks and 20 weeks post‐stroke at commencement of trial, currently participating in an inpatient or outpatient rehabilitation programme and able to walk 15 metres indoors on a level surface, with or without an aid, with supervision" Exclusion criteria: "independent mobility indoors achieved within four weeks post‐stroke, premorbid mobility limited to walking indoors only, unable to follow single stage verbal commands with visual prompts and mobility disability due primarily to pathologies other than stroke" |
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Interventions | (1) Bobath intervention (n = 12) "Intervention A was based on the Bobath concept. In this intervention, participants received individual treatment prescription based on the Bobath concept towards the goal of improving walking ability in different environmental contexts. This intervention included detailed assessment of the individual’s movement strategies and the neurological and neuromuscular deficits underlying motor dysfunction. Treatment strategies were individualized and aimed at both reducing the severity of impairments where they impacted on function, and optimizing postural and movement strategies to improve efficiency and maximize function" "The specific goal of therapy in this study was to improve the ability of the participant to walk safely in different environments, including components of endurance, walking on slopes, going up and down a single step and walking over rough ground. The session incorporated structured task practice (as described in intervention B) for 1/6 of the treatment time allocated" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising cardiopulmonary intervention, functional task training and neurophysiological intervention Length of intervention period: two weeks Number of sessions and length of individual sessions: "Participants in both groups received six one hour physiotherapy sessions over a two‐week period. During the intervention period, participants did not receive any other physiotherapy aimed at improving mobility, posture, balance or lower limb function. Instead, the intervention sessions replaced the usual physiotherapy treatment for mobility. Additional physiotherapy was provided in sitting or lying for other rehabilitation goals, such as independence in bed mobility and recovery of upper limb function" Intervention provider: "Both interventions were performed by physiotherapists with at least five years’ postgraduate experience and at least two years’ experience in the fields of rehabilitation or neurology. In addition, therapists providing Intervention A had to have also completed a Basic Bobath Course and at least two Advanced Bobath Courses (a minimum of 180 hours of formal training acquired over a minimum of three years)" (2) Task practice intervention (n = 14) "Participants receiving Intervention B undertook physiotherapy based on structured task practice. The supervised exercise programme aimed to provide repeated task specific practice of environmental contexts frequently encountered in walking outdoors. The tasks practised focused on increasing endurance, walking on slopes, going up and down a single step and walking over rough ground. Based on principles of motor learning, the therapist provided instruction in how to perform the task, including demonstration, verbal cueing to correct ineffective adaptive motor patterns and feedback on the performance of the task as specified by the study protocol, as well as supervision for safety. The therapist did not provide hands‐on assistance or guidance during tasks. Half of the task practice component was conducted as repetitive practice using standardized equipment in the gymnasium, reflecting the closed skill stage of learning. The other half of the time was spent in environments outside the gymnasium, walking on varying surfaces indoors and outdoors, bringing in other environmental contexts, such as differing attentional demands and changes in direction" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising cardiopulmonary intervention and functional task training Length of intervention period: two weeks Number of sessions and length of individual sessions: "Participants in both groups received six one hour physiotherapy sessions over a two‐week period" Intervention provider: "Physiotherapists with at least five years’ postgraduate experience and at least two years’ experience in the fields of rehabilitation or neurology" This study was classified as: active intervention one (functional task training, neurophysiological) versus active intervention two (functional task training) (Table 9). Both intervention groups also received cardiopulmonary intervention |
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Outcomes | Measures of postural control and balance: Berg Balance Scale Measures of voluntary movements: adapted Six‐Minute Walk test, gait velocity Time points when outcomes were assessed: "Measures were taken at baseline, and following treatment…Post‐intervention assessment measures were recorded between one and five days following the intervention" |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was done through a computer‐generated, stratified, blocked randomization procedure. Separate computer‐generated randomizations were used for each site. Opaque envelopes were used to conceal group allocation. Participants were randomized and assigned to the intervention groups after the baseline assessments were carried out" |
Allocation concealment (selection bias) | Low risk | "Patients were stratified according to time period from date of stroke to date of commencement in the trial. The two strata were four weeks to eight weeks post‐stroke at commencement of the trial and more than eight weeks post‐stroke. This stratification aimed to improve the likelihood of the two groups being similar in terms of initial severity and speed of recovery post‐stroke, as those with milder stroke and a quicker rate of recovery are likely to improve more rapidly during the time period of the study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Measures were taken at baseline, and following treatment, by a physiotherapist who was blind to group assignment" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Twenty‐nine participants were recruited to the study. Note that two participants did not complete the study because they were discharged from inpatient rehabilitation earlier than anticipated and could not complete the study as outpatients. One participant was withdrawn due to ill health" Both of the early discharges were in the same (Bobath) group. Intention‐to‐treat analysis not completed—unclear whether these dropouts could contribute to attrition bias |
Free of systematic differences in baseline characteristics of groups compared? | Low risk | "No significant differences between groups at baseline for the six minute walk test (P = 0.79), gait velocity (P = 0.27) and Berg Balance Scale (P = 0.77)" |
Did authors adjust for baseline differences in their analyses? | Low risk | No information provided |
Other bias | Unclear risk | "No data are available regarding the number of patients eligible to participate or reasons for not participating. However, for both centres, the main limiting factor to recruitment was planned discharge to a distant locality shortly after achieving walking with supervision, preventing participation" |