Balance right in multiple sclerosis

Conditions

Specialty: Neurological disorders, Primary sub-specialty: Multiple sclerosis

Gunn H, Stevens KN, Creanor S, Andrade J, Paul L, Miller L, Green C, Ewings P, Barton A, Berrow M, Vickery J, Marshall B, Zajicek J, Freeman JA.

2021-01-0410 citations

10.1186/s40814-020-00732-9

A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

Hilary Gunn, Jackie Andrade, Lorna Paul, Linda Miller, Siobhan Creanor et al. (14 authors)

Health Technology Assessment2019-06-0116 citations

10.3310/hta23270

Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial.

Gunn H, Andrade J, Paul L, Miller L, Creanor S, Green C, Marsden J, Ewings P, Berrow M, Vickery J, Barton A, Marshall B, Zajicek J, Freeman JA.

2017-07-279 citations

10.1186/s40814-017-0168-1

Interventions

Participants will be randomised in a 1:1 ratio in blocks of 10 either to a manualised 13-week education and exercise programme (BRiMS) plus usual care (Intervention) or to usual care alone (Control).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of secondary progressive MS (SPMS) as determined by neurologist's opinion 2. Aged 18 years or older 3. Willing and able to understand/comply with all trial activities 4. Expanded Disability Status Scale (EDSS) = 4.0 = 7.0 ie: those people who at best have difficulty waliking 500 metres without aid or rest; and at worst are unable to walk more than 5 metres even with an aid 5. Self-report two or more falls in the past six months 6. Willing and able to travel to and participate in BRiMS group sessions in local centres and to commit to undertaking their individualised home-based programme 7. Access to a computer or tablet and to the internet

Exclusion criteria

Exclusion criteria: 1. Patient report of relapse or having received steroid treatment within the last month 2. Any recent changes in disease-modifying therapies. More specifically patients will be excluded if: 2.1. They have ever had previous treatment with Alemtuzemab (Lemtrada / Campath) 2.2. Ceased Nataluzimab (Tysabri) in the last 6 months 2.3. Within three months of ceasing any other MS disease-modifying drug 3. Participated in a falls management programme (e.g. for older people) within the past six months 4. Co-morbidities which may influence the ability of individuals to participate safely in the programme or likely to impact on the trial (e.g. uncontrolled epilepsy)

Design outcomes

Primary

Measure	Time frame
Selection of an appropriate primary outcome measure for the full scale trial is undertaken through blinded assessments of the MS Walking Scale-12vs2.0, EuroQoL EQ5-D5L and MS Impact Scale-29vs2.0 at baseline, 13 and 25 weeks.	—

Secondary

Measure	Time frame
1. Patient and clinician reported outcomes related to falls and injury rates will be measured by the self-reported fortnightly falls patient diaries for the duration of the study 2. Activity level will be measured by activity monitors worn for 1 week at baseline, 13 and 25 weeks 3. Walking will be assessed by the self-report MSWS-12 questionnaire and an objective clinician-rated measure of walking capacity - the two-minute walk test (2MWT) carried out at baseline, 13 and 25 weeks 4. Balance will be assessed by The Mini-Balance Evaluation Systems Test (Mini-BEST) and the Functional Reach Test (FRT, forwards and lateral) carried out at baseline, 13 and 25 weeks 5. Fear of falling will be measured with the 16-item self-report Falls Efficacy Scale (International) (FESi) at baseline, 13 and 25 weeks 6. Community integration will be measured using the self-report Community Participation Indicators (CPI) questionnaire at baseline, 13 and 25 weeks	—

Measure

Time frame

1. Patient and clinician reported outcomes related to falls and injury rates will be measured by the self-reported fortnightly falls patient diaries for the duration of the study 2. Activity level will be measured by activity monitors worn for 1 week at baseline, 13 and 25 weeks 3. Walking will be assessed by the self-report MSWS-12 questionnaire and an objective clinician-rated measure of walking capacity - the two-minute walk test (2MWT) carried out at baseline, 13 and 25 weeks 4. Balance will be assessed by The Mini-Balance Evaluation Systems Test (Mini-BEST) and the Functional Reach Test (FRT, forwards and lateral) carried out at baseline, 13 and 25 weeks 5. Fear of falling will be measured with the 16-item self-report Falls Efficacy Scale (International) (FESi) at baseline, 13 and 25 weeks 6. Community integration will be measured using the self-report Community Participation Indicators (CPI) questionnaire at baseline, 13 and 25 weeks

—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactHilary Gunn

hilary.gunn100@plymouth.ac.uk+44 (0)1752 588825

Outcome results

None listed