Balance right in multiple sclerosis

Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants will be randomised in a 1:1 ratio in blocks of 10 ither to a manualised 13‐week education and exercise programme (BRiMS) plus usual care (Intervention) or to usual care alone (Control). Intervention group: Participants will be invited to participate in the BRiMS programme alongside their usual care. The BRiMS programme is delivered as a 13‐week therapy‐led personalised education and exercise intervention, structured to maximise the development of self‐efficacy and support participant engagement. BRiMS addresses modifiable fall risk factors such as poor balance and mobility and enables self‐management by the use of individualised mobility, safety and falls risk management strategies. The programme includes a one‐to‐one assessment session, a home visit and three group sessions alongside a home programme of exercise and education activities. The programme is supported throughout by online interactive resources and input from an experienced physiotherapist. Control group: Participants will continue to receive their usual clinical care alone. Usual care is likely to vary significantly between participants and regions, but typically involves occasional appointments with a variety of health professionals (for example physiotherapist, occupational therapist, general practitioner, MS nurse specialist, neurologist, rehabilitation consultant). Multi‐disciplinary interventions are usually short term, since resource restrictions limit the provision of long‐term maintenance therapy. Specialist falls programmes for older people exist in most locations across the UK, however, these are seldom accessed by people with MS. Some programmes specifically exclude those with neurological conditions from attending, and have lower age restrictions which present further barriers. The trial will record the content of usual care for all participants at each follow up assessment. Participants in both groups will be assessed at baseline, thirteen and twenty‐five weeks. CONDITION: Specialty: Neurological disorders, Primary sub‐specialty: Multiple sclerosis; UKCRC code/ Disease: Neurological/ Demyelinating diseases of the central nervous system ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: 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. 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 SECONDARY OUTCOME: 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
Epistemonikos ID: 0f7034c441fdfe4272a6dcbd4418696ad12915b8
First added on: Aug 24, 2024