RecruitingACTRN12616000415404

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?


Sponsor

University of Sydney

Enrollment

100 participants

Start Date

Apr 18, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a home-based whole-body vibration (WBV) platform — a machine you stand on that vibrates your body — can help people with multiple sclerosis (MS) improve their balance, reduce falls, and get around more easily. MS can damage the nerves that control movement, which makes falling a real risk. Researchers are comparing WBV combined with regular exercise to exercise alone to see which works better. You may be eligible if: - You have been diagnosed with multiple sclerosis - You are aged 18 to 65 years - Your disability level (EDSS) is between 2 and 6 - You can walk independently, with or without an assistive device (such as a cane) You may NOT be eligible if: - You have had a relapse in the last 3 months - You have had corticosteroid treatment within 28 days of the study starting - You have any other health condition that makes exercise unsafe for you Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 mo

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.


Locations(4)

Westmead Hospital - Westmead

NSW, Australia

Neuroscience Research Australia (NeuRA) - Randwick

NSW, Australia

Brain and Mind Centre - University of Sydney - Camperdown

NSW, Australia

Multiple Sclerosis Ltd (MS Ltd) - Studdy MS Centre - Lidcombe

NSW, Australia

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ACTRN12616000415404


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