Gelber 1995.
Study characteristics | ||
Methods | Study design: RCT Method of randomisation: "patients were randomised to one of two treatment arms" | |
Participants | Number of participants: n = 27 Inclusion criteria: pure motor hemiparetic ischaemic stroke, less than one month post stroke; no cognitive, language, visual, sensory or bilateral deficits; no history of stroke and no premorbid use of walking stick | |
Interventions | (1) Neurodevelopmental Technique (NDT) group (n = 15)
"Inhibition of abnormal muscle tone and initiation of normal (good quality) motor movements with progression through developmental sequences prior to advancing to functional activities. Therapy techniques included tone inhibition and weight bearing activities, and encouraged patients to use their affected side. Resistance exercises and use of abnormal reflexes and mass movements were avoided." All therapists had received training and evaluation in use of the approaches and were given ‘strict guidelines' for treatment. 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: "continued for the duration of the inpatient and outpatient rehabilitation programmes" Number of sessions and length of individual sessions: not stated Intervention provider: "these treatment approaches were used by both the physiotherapists and occupational therapists who treated the patients, and were used throughout the patients' time as both inpatients and outpatients. All interventions were administered according to allocated treatment group. The nursing staff reinforced any practice of techniques that patients were to carry out outside their treatment sessions" (2) Orthopaedic group (traditional functional retraining: TFR) (n = 12) "Practicing functional tasks as early as possible even in the presence of spasticity or abnormal postures" "Passive range of movement; resistive exercises; assistive devices and bracing allow use of unaffected side to perform functional tasks. Therapists had all received training and evaluation in the use of the approaches, and were given ‘strict guidelines' for treatment" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising assistive devices, functional task training, musculoskeletal interventions (active) and musculoskeletal interventions (passive) Length of intervention period: "continued for the duration of the inpatient and outpatient rehabilitation programmes" Number of sessions and length of individual sessions: not stated Intervention provider: as above This study is classified as active intervention one (functional task training, neurophysiological) versus active intervention two (functional task training, musculoskeletal (active), musculoskeletal (passive)) (Table 9). Intervention group two also received assistive devices |
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Outcomes | Measures of Independence in ADL: Functional Independence Measure
Measures of voluntary movement: parameters of gait
Other measures: length of stay and inpatient hospital costs; Box and Block test; 9‐Hole Peg test Time points when outcomes were assessed: "All of the outcome measures were evaluated at admission, discharge, six months and at twelve months follow‐up" |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided ("patients were randomised to one of two treatment arms") |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unclear whether the participant was blinded Therapist was not blinded The same therapists provided treatment to participants in both treatment groups, creating a possibility of contamination between the groups Assessor was not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts accounted for 27/27 completed intervention 16/27 at follow‐up assessments (23/27 for Functional Independence Measure, carried out by telephone) |
Free of systematic differences in baseline characteristics of groups compared? | Low risk | "NDT and TFR treated patients did not differ with respect to age, gender, side of stroke or days from stroke to entry in the study" |
Did authors adjust for baseline differences in their analyses? | Low risk | No information provided |
Other bias | Unclear risk | The nursing staff reinforced any practice of techniques that participants were to carry out outside of their treatment sessions; this difference in nursing care may introduce performance bias |