| Methods |
RCT. |
| Participants |
Italy N = 111 (5 drop outs), Treatment = 58 (4 drop outs), control = 53 (1 drop out) |
| Interventions |
Treatment group ‐ comprehensive outpatient rehabilitation programme followed by a home exercise programme for 6 weeks.Control group ‐ Home exercise programme for 12 weeks. |
| Outcomes |
EDSS, FIM |
| Notes |
Same group of patients as Patti 2002 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated randomisation sequence stratified by EDSS score, with wait list control group. |
| Allocation concealment (selection bias) |
Low risk |
Numbered opaque sealed envelopes used to conceal allocation. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No blinding of participants and treating personnel |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessors blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Overall 5% dropout. |
| Selective reporting (reporting bias) |
Low risk |
All pre‐specified primary and secondary outcomes reported. |
| Other bias |
Low risk |
Analyses were performed according to ITT. |
