None listed
Conditions
Brief summary
Falls are common among people with multiple sclerosis (MS). About 60% of people with MS (PwMS) experience at least one fall each 6 months and about 30% have multiple falls. Increased fall risk and fear of falls have been shown to significantly affect quality of life and curtail activities among people with MS. Therefore, effective interventions to reduce fall risk in PwMS are urgently needed. Fall prevention and treatment strategies in MS are still at an early stage. Studies on falls in MS reveal important balance, coordination and cognitive determinants of falls. Based on these results, we propose a randomised single-blind controlled trial (RCT) to evaluate a step training intervention designed to prevent falls in PwMS. The proposed trial will enrol approximately 500 PwMS over a period of 36 months. Recruitment will initially take place in NSW and will be extended to other Australian states if required. It is expected that if the research confirms effectiveness of treatment strategies, implementation of clinical interventions will contribute to reduced fall rates in PwMS and associated injury-associated costs, reduced fear of falls and improved quality of life for PwMS.
Interventions
The intervention consists of balance and step training delivered through a novel home-based step-training system (smart +/- step). The system involves a computerised training mat measuring approximately one square metre with eight step panels and connected to a visual display (television or computer screen) that displays training instructions and game-based stepping exercises. The exercises will be tailored to the participant's abilities for the duration of the trial.
STUDY PROTOCOL
* During a
The intervention consists of balance and step training delivered through a novel home-based step-training system (smart +/- step). The system involves a computerised training mat measuring approximately one square metre with eight step panels and connected to a visual display (television or computer screen) that displays training instructions and game-based stepping exercises. The exercises will be tailored to the participant's abilities for the duration of the trial. STUDY PROTOCOL * During an initial home visit, a trained researcher (exercise physiologist or physiotherapist) will set up and demonstrate the 'smart +/- step' step-training system, ensuring the participant can use the equipment safely on their own. This visit is expected to take approximately 60-90 minutes. * A follow up home visit will be scheduled approximately four weeks following the initial home visit to ensure participant safety during exercise, progression of the training and to discuss any issues relating to use of the program. This visit is expected to take approximately 30 minutes. * Dose of exercise training will be at least 120 minutes per week during the 6-month intervention period. Participants are able to determine the frequency and duration of each exercise session according to their preference. * Participant adherence (training volume, frequency) will be monitored through automatic data transfer to a server, and will be examined weekly. Participants not engaging in the minimum weekly training dose for 2 consecutive weeks will be contacted by telephone to discuss any issues and to encourage adherence during the 6-month intervention period. * Phone support will be available and additional home visits will be offered as needed/requested for the entire duration of the study.
Sponsors
Professor Stephen Lord
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years and over * Living in the community * Confirmed diagnosis of Multiple Sclerosis (MS) * Expanded Disability Status Scale (EDSS) between 2 and 6 * No apparent cognitive impairment, being able to understand and follow test instructions * Stable MS (with or without disease-modifying drugs) with no exacerbation in the past 30 days * Currently not involved in any falls prevention exercise research trials
Exclusion criteria
* Unable to perform the Choice Stepping Reaction Time test * Unable to walk 10 metres without bilateral mobility aid * Existing conditions that prevent exercise (e.g. severe pain, heel ulcers, severe spasticity, excessive fatigue, exercise intolerance) or have been advised by a medical doctor not to exercise * Relapse of MS in the past 30 days
Outcome results
None listed