Methods/design: This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation.
The outcomes of this feasibility trial include:
• Feasibility outcomes, including trial recruitment, retention and completion
• Assessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)
• Measures of adherence to the BRiMS programme
• Data to inform the economic evaluation in a future trial
• Process evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience)
Discussion: The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.
- Secondary progressive multiple sclerosis
- Accidental falls
- Quality of life
- Feasibility randomised controlled trial