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Interventions to improve gait and reduce falls in people with multiple sclerosis (MS)

Do interventions targeting proprioceptive feedback and exercise improve functional gait and reduce falls and falls risk in people with MS?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000415404
Enrollment
100
Registered
2016-03-31
Start date
2016-04-18
Completion date
2017-03-28
Last updated
2020-01-13

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 study examines an intervention that provides additional sensory feedback during exercise. We are investigating the effectiveness of home-based whole-body vibration training to improve mobility outcomes and reduce prospective falls and or falls risk compared to standard exercises in people with MS. The hypotheses of this study are that risk of falling and the number of prospective falls will be reduced and dynamic balance, endurance, and functional mobility will be improved after whole body vibration intervention and exercise compared to standard exercises alone.

Interventions

Participants in the intervention group will perform four exercises at home on a whole body vibration (WBV) board, at least 3 times a week for 10 weeks. Patients are allowed to perform the exercises more frequently if they wish but no more than once a day. Each exercise session should take ~30 minutes. A trained research assistant will instruct participants on the exercises to be performed during the initial home visit. This should take ~1 hour. All participants will be instructed to perform t

Participants in the intervention group will perform four exercises at home on a whole body vibration (WBV) board, at least 3 times a week for 10 weeks. Patients are allowed to perform the exercises more frequently if they wish but no more than once a day. Each exercise session should take ~30 minutes. A trained research assistant will instruct participants on the exercises to be performed during the initial home visit. This should take ~1 hour. All participants will be instructed to perform the following four exercises: - Dynamic bilateral squats for 3 sets of 8 repetitions with 3 second holds - Static bilateral squats for 3 sets with 30 seconds ‘hold’ - Bilateral marching for 30 seconds continuously - Dynamic calf raises for 3 sets of 8 repetitions for each leg They can rest between exercises but for no more than 1 minute. The cool down and warm up will involve walking around their home at their own pace for 2 minutes. Halfway into the 10-week intervention block participants will receive an additional 30 minute home visit for instructions to increase exercise progression as appropriate. This may include increasing duration, repetitions, sets, or the use of a weighted vest. Participants will also receive a phone call, lasting approximately 10 minutes, every ~4 weeks by the trained research assistant to ensure compliance and appropriate progression. The Fall Calendars will be collected ~monthly for 20 weeks. The WBV group will be instructed in how to perform the exercises on the WBV platform and in the use of the SilverMink V-988 electrically controlled exercise system supplied by SaunaGem Australia. The SilverMink WBV system is registered with Australian Register of Therapeutic Goods (ARTG). The ARTG Number is 136007; the ARTG Product Number and Name: 222559 Massager, physical therapy. Potential risks using the unit include the possibility of falling off the platform, which could result in other injuries. However, the WBV platforms have handles that participants are able to hold onto and a safety strap to prevent them from falling backwards off the unit. Participants may experience mild discomfort and/or fatigue during and after the testing and exercise sessions. Some people may develop mild soreness in some muscles one to two days after exercise. If participants experience a relapse during participation they will be advised to stop exercise until after being reviewed by their physician and deemed ready to exercise again. The follow up measures for these participants will be conducted as their conditions allow.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Participants with MS, Expanded Disability Status Scale (EDSS) Level ranging from 2-6, and can walk independently (with or without the use of an assistive device) will be invited to participate.

Exclusion criteria

Participants will be screened and excluded from the study if they have had a relapse within the last 3 months, corticosteroid treatment within 28 days of the study commencement, or have contra­indications for exercise.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026