Jordbru 2014.
| Study characteristics | ||
| Methods |
Study design: randomised controlled trial Study grouping: cross‐over Adequate power (evidence of power calculation): no specific power calculation mentioned. Allocation concealment method: the first author was blinded to information about intervention or control group, which was kept in sealed envelopes. Blinding of outcome assessors: first author (assessing FIM) was blinded to randomisation. Check of blinding: no information provided. Duration of study: May 2007 to October 2010. Randomisation method: randomisation procedure was performed at a statistical office at a site remote from where the study was conducted. Participants were randomised consecutively and equally (with a 1:1 ratio) to immediate 3 weeks of treatment or 4 weeks on a wait list. Those on the wait list received treatment after the waiting period. |
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| Participants |
Baseline characteristics Intervention
Control
Overall
Inclusion criteria: disabling walking disturbance resembling psychogenic gait with no organic explanation after neurological examination; aged 18–69 years; duration < 5 years, and willingness to participate in the study. Exclusion criteria: people who needed inpatient psychiatric treatment, people with coexistent somatic disorders (multiple sclerosis, cerebral palsy, etc.) or people who did not want to take part in active rehabilitation. Pretreatment: no statistically significant differences at baseline between groups. |
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| Interventions |
Intervention characteristics Intervention
Control
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| Outcomes |
Level of functioning (FIM)
Mental state (SF‐12)
Dropout
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "the randomisation procedure was performed at a statistical office at a site remote from where the study was conducted. the first author was blinded to information about intervention or control group, which was kept in sealed envelopes. the envelopes were allocated to patients consecutively in the same order as patients had given written informed consent." |
| Allocation concealment (selection bias) | Low risk | Participants randomly assigned by blocks of 4, balanced for sex, to intervention or control groups. The randomisation procedure was performed at a statistical office at a site remote from where the study was conducted. The first author was blinded to information about intervention or control group, which was kept in sealed envelopes. The envelopes were allocated to participants consecutively in the same order as participants had given written informed consent. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the patients from the intervention group, as well as the control group, were consecutively admitted to the ward, and the team did not know to which group the patients were allocated." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "The first author handled all data collection and was not involved in the treatment." Comment: the first author was blinded to information about randomisation. Some outcomes were self‐reported and participants were not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout was accounted for well up to the latest time point. |
| Selective reporting (reporting bias) | Unclear risk | No protocol. |
| Other bias | Low risk | No apparent other sources of bias. |