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MS-SAFE: Stepping to Avoid Fall Events in Multiple Sclerosis

Training protective stepping responses to trips and slips in people with multiple sclerosis

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001436268
Enrollment
29
Registered
2018-08-28
Start date
2018-08-28
Completion date
2020-03-12
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will examine feasibility, mechanisms and efficacy of reactive step training as a fall-prevention strategy for people with MS. Forty-four people with MS will be recruited and assessed for balance recovery responses after slips and trips. Equipped with a full-body safety harness and foot protectors, People with MS will be exposed to a slip (70cm length) and a trip (14cm height) using our perturbation system. Twenty-two participants randomized to the intervention group will undertake 2 weekly individual 50-minute sessions (100 minutes in total) with each session focusing on balance recovery from a mix of trips and slips (week 2). Intensity of the training (e.g. gait speed, slip distance/speed and trip height) will be individualized and progressed according to participant ability. The control group will undertake 2 weekly 50-min session of sham training. Following training/sham, balance recovery response to slips and trips will be assessed. Kinematic, kinetic and physiological data will be collected to explore mechanisms for how people with MS improve their balance recovery responses.

Interventions

Reactive step training sessions will be undertaken in 2 supervised individual sessions over 2 weeks. During each session, a participant will visit Neuroscience Research Australia for 50-minutes of training, focusing on balance recovery from mix of trips and slips (30 trials). A perturbation system built on a 10-m walkway consisting of 50cm x 50cm wooden decking tiles will be used to induce slips and trips (Okubo et al., 2018). Participants walk while being secured with a ceiling-mounted full bod

Reactive step training sessions will be undertaken in 2 supervised individual sessions over 2 weeks. During each session, a participant will visit Neuroscience Research Australia for 50-minutes of training, focusing on balance recovery from mix of trips and slips (30 trials). A perturbation system built on a 10-m walkway consisting of 50cm x 50cm wooden decking tiles will be used to induce slips and trips (Okubo et al., 2018). Participants walk while being secured with a ceiling-mounted full body harness to avoid falling to the ground. Gait speed during this training will be individually set to approximately 80% (or 50-100% if adjustment is required) of usual speed using a metronome corresponding to individualised cadence. Interspersed with normal walk trials will be a series of trip and slip perturbations with increasing levels of unpredictability and 4 short breaks. A slip is induced by a movable tile on two hidden low-friction rails with linear bearings that result in a slide of 20-70cm upon foot contact. A trip is induced using a 7-14cm height tripping board that springs up from the walkway at mid-swing using a foot detection sensor. Unpredictability of perturbation will be progressively increased so that reactive stepping responses can be gradually and safely trained. Participant performance and anxiety status will be closely monitored and intensity of perturbation (i.e. trip height, slip distance/speed and gait speed) may be adjusted to appropriately progress the challenge and training effects. All training sessions will be conducted individually with an Exercise Physiologist and an assistant.

Sponsors

Prof Stephen Lord
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Aged between 18 years or older, 2) Living in the community, 3) Confirmed diagnosis of MS, 4) Expanded Disability Status Scale (EDSS) between 1 and 5.5, 5) No apparent cognitive impairment, 6) Being able to understand and follow test instructions, 7) Stable MS (with or without disease modifying drugs) with no exacerbation in the past 30 days. 8) Exercising for 60 minutes per week (e.g. fitness class, walking, strength training, Tai Chi, etc) for the past 3 months.

Exclusion criteria

1) Unable to walk 5 minutes without a bilateral mobility aid, 2) Existing conditions that prevent exercise (e.g. severe pain, heel ulcers, severe spasticity, excessive fatigue, exercise intolerance), 3) A relapse of MS in the past 30 days 4) Advised by a medical practitioner not to exercise. 5) History of fracture in the past 3 years or joint replacement in the past 12 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026