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Investigating Fatigue, Balance, Falls and Mobility in people with Multiple Sclerosis

Investigating Fatigue, Balance, Falls and Mobility in people with Multiple Sclerosis - Walking with or without DorsiFlexion Assist

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000218897
Enrollment
35
Registered
2012-02-21
Start date
2011-01-01
Completion date
Unknown
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

The purpose of this study is to examine the effects of fatigue on mobility, balance and falls risk in people with Multiple Sclerosis. We also would like to investigate the effect of a simple Dynamic Dorsiflexion Ankle Orthosis (DDAO) on mobility and balance.

Interventions

All subjects will be trialled in the following conditions in: - Condition A - Rest - Condition B - Walking without DorsiFlexion Assist - Condition C - Walking with DorsiFlexion Assist All subjects will be tested under each condition. The order of the conditions will be randomised. All assessments will be completed within 3 weeks, with at least 2 days between each assessment. This will ensure that results are not affected by disease progression why allowing some time to recover between asses

All subjects will be trialled in the following conditions in: - Condition A - Rest - Condition B - Walking without DorsiFlexion Assist - Condition C - Walking with DorsiFlexion Assist All subjects will be tested under each condition. The order of the conditions will be randomised. All assessments will be completed within 3 weeks, with at least 2 days between each assessment. This will ensure that results are not affected by disease progression why allowing some time to recover between assessments. Conditions Condition A: No Fatigue In Condition A, the participant will sit and rest for 6 minutes. Condition B: Fatigue-The 6 Minute Walk Test (6MWT) The participant will undertake a modified six-minute walk test (6MWT). This is a variation of the original American Thoracic Society Script.("ATS statement: guidelines for the six-minute walk test," 2002). This involves the participant walking unaided up and down a 10m straight walkway for six minutes with the use of a modified script that aims to maximise effort and test endurance.(Goldman et al., 2007) Distance will be measured every minute, as well as participants rating of perceived exertion (RPE) using the modified Borg scale.(Borg, 1982) While encouraged to continue walking throughout the test, participants are permitted to slow down, stop and rest as necessary. Heart Rate will be continually monitored throughout the 6MWT. Condition C: Fatigue + Dynamic DorsiFlexion Ankle Orthosis (DDAO) The participant will wear the same shoes as in Conditions A & B. The Dorsiflexion Assist Orthosis (DOA) (Foot-Up, Ossur) will be fitted around the ankle and underneath the laces of the shoe. This device assists ankle dorsiflexion with a dynamic elastic support attached to the shoe and no direct contact with the foot. The device therefore does not alter the participant’s existing abilities to detect pressure sensations in the sole of the foot used to assist balance control. The experiment is completed in exactly the same way as described for Condition B.

Sponsors

MS Australia
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Subjects fulfilling the following inclusion criteria will be identified and recruited for the study: - Definite Diagnosis of MS. - Mild to moderate difficulty in mobility with EDSS score 3.5-5.0 - Medical Clearance by the subjects General Practitioner

Exclusion criteria

The exclusion criteria include: - Exacerbation/Relapse of MS - Use of medication prescribed for Fatigue e.g. Amantadine, Modafinil - Significant Cardiac or respiratory disease - Severe depression - Severe arthritis, fibromyalgia or pain with walking

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 26, 2026