| Trial name or title |
An interactive step training system to reduce falls in people with multiple sclerosis: a randomised controlled trial |
| Methods |
Randomised controlled trial |
| Participants |
Confirmed diagnosis of Multiple Sclerosis with Expanded Disability Status Scale score between 2 and 6 |
| Interventions |
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 control group: 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 |
| Outcomes |
The proportion of fallers in each group: Falls will be monitored with monthly falls diaries for the 12 months after baseline assessment;The rate of fallers in each group: Falls will be monitored with monthly falls diaries for the 12 months after baseline assessment;Static and dynamic balance will be measured using the swaymeter device from the Physiological Profile Assessment;Clinical measures of lower leg strength will be measured using a dynamometer;Clinical measures of gait (velocity and distance) will be assessed with the 10‐metre and 6‐minute walk tests;Clinical measures of stepping will be measured using the Choice Stepping Reaction Time (CSRT) tests;MS disease severity will be measured using the Multiple Sclerosis Functional Composite (MSFC);Questionnaire measure of concern about falling using the Iconographical Falls Efficacy Scale;Questionnaire measure of physical activity levels using the Incidental Planned Exercise Questionnaire;Cognition measured using the Trails A and Trails B tests;Questionnaire measure of quality of life using the European Quality of Life ‐ 5 Dimensions and World Health Organisation Disability Assessment Schedule 2.0;Questionnaire measure of mood using the Patient Health Questionnaire‐9;Questionnaire measure of fatigue using the Modified Fatigue Impact Scale;Cost‐effectiveness of the intervention measured by data linkage to fall‐related medical health records;Movement detection threshold about the ankle joint measured using a motorised foot plate designed for this study;Maximal isometric voluntary force of the calf muscles measured with surface electrodes <br>;Measures of sleep disruption using a take‐home sleep testing device. Home testing will be performed using either a standard Type 2 (e.g. Nox A1 Polysomnography system) or Type 3 (e.g. ResMed ApneaLink plus) device.;Questionnaire measures of sleepiness and sleep quality using the Epworth Sleepiness Scale, Functional outcomes of sleep questionnaire, Karolinska sleepiness scale, and Pittsburgh sleepiness scale;Screening questionnaires for the presence of sleep apnoea measured using the STOP BANG, Berlin sleep questionnaire, and OSA50;Joint position sense about the ankle joint measured using a motorised foot plate designed for this study;Reaction time to small movements about the ankle joint using a motorised foot plate designed for this study;Voluntary activation of the calf muscles using twitch interpolation and measured with surface electrodes;Twitch force of the calf muscles elicited by electrical stimulation and measured with surface electrodes;Fatigue of the calf muscles with a sustained isometric contraction measured with electrical muscle stimulation and surface electrodes;Daily life walking patterns measured with a wearable physical activity monitor over a seven day period ;Sit to stand transitions measured with a wearable physical activity monitor over a seven day period;Number of near falls, slips or trips measured with a wearable physical activity monitor over a seven day period;Total energy expenditure from activities of daily living measured with a wearable physical activity monitor over a seven day period;Sedentary time measured with a wearable physical activity monitor over a seven day period;Daily life sleeping patterns measured with a wearable physical activity monitor over a seven day period;Dual task cost assessed with a dual task and 10‐metre walk |
| Starting date |
23/08/2016 |
| Contact information |
s.lord@neura.edu.au |
| Notes |
Ongoing study‐ recruiting |
