Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000218897
Ethics application status
Approved
Date submitted
6/02/2012
Date registered
21/02/2012
Date last updated
21/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating Fatigue, Balance, Falls and Mobility in people with Multiple Sclerosis
Scientific title
Investigating Fatigue, Balance, Falls and Mobility in people with Multiple Sclerosis - Walking with or without DorsiFlexion Assist
Secondary ID [1] 279631 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 285431 0
Falls, Balance and Mobility 285599 0
Condition category
Condition code
Neurological 285610 285610 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284265 0
Treatment: Devices
Comparator / control treatment
Condition A (Rest) is the control.
Control group
Active

Outcomes
Primary outcome [1] 286175 0
6 Minute Walking Test Distance
Timepoint [1] 286175 0
Following 6MWT in Conditions B & C.
Primary outcome [2] 286464 0
Change in Modified Borg Rating of Perceived Exertion
Timepoint [2] 286464 0
Immediately before and after 6 minute testing for conditions A, B & C.
Primary outcome [3] 286465 0
Physiological Cost Index (PCI) of Walking
Timepoint [3] 286465 0
On completion of 6MWT in Conditions B & C.
Secondary outcome [1] 295304 0
Change in Perceived Fatigue Levels Visual Analogue Scale for Fatigue (VAS -F)
Timepoint [1] 295304 0
Immediately before and after 6 minute testing for conditions A, B & C.
Secondary outcome [2] 295928 0
3D Gait Analysis

- Spatio-Temporal Speed, cadence, step length, double limb support time

- Kinematics Ankle dorsiflexion angle swing phase, knee angle stance phase

- Kinetics Peak Ankle Power, knee flexion/extension moments in stance phase

3D gait analysis will be conducted using an 8 camera Vicon MX3 system (Vicon, Oxford, UK) with 4 AMTI ( AMTI, Watertown, MA) force plates and Helen Hayes [DLS2] marker set. Spatiotemporal data and kinematic and kinetic data for the hip knee and ankle will be collected over a minimum of 6 walking trials with and without the DAO. Data will be collected using Vicon Nexus software (v1.4) and processed with Matlab (v7.0). Sagittal plane angles at the ankle are of particular interest, to examine effects of the DAO, in addition to knee and hip angles to identify potential compensations for DAO effects at the ankle. We also interested in any fatigue related changes to gait pattern that may occur following the 6MWT.
Timepoint [2] 295928 0
Immediately before and after 6 minute testing for conditions A, B & C.
Secondary outcome [3] 295929 0
Strength (kg)

Knee Extensors, Ankle Dorsiflexors

Knee extension and ankle dorsiflexion strength will be determined as isometric force (kg) produced, measured with a strain gauge linear to direction of force production, normalised to body mass. Strength tests will be conducted in a seated position. For knee strength testing, the hip and knee will be positioned in 90 degrees of flexion. The test of ankle strength will be conducted with the ankle at 30 degrees of plantarflexion. Each strength test will be repeated 3 times with sufficient rest in between, and the maximum score recorded.
Timepoint [3] 295929 0
Immediately before and after 6 minute testing for conditions A, B & C.
Secondary outcome [4] 295930 0
Simple Reaction Time (ms) Hand and Feet

Participants will be seated in a chair with ceiling lights dimmed. Simple reaction time will be measured in milliseconds using a handheld electronic timer, with participants seated and using a light as the stimulus and a finger-press (hand reaction time) or a foot-press (foot reaction time) as the response. Five practice trials will be followed by an additional 10 trials, for which reaction time in milliseconds will be recorded for each trial and averaged.
Timepoint [4] 295930 0
Immediately before and after 6 minute testing for conditions A, B & C.
Secondary outcome [5] 295931 0
Choice Stepping Reaction Time (ms) (CSRT)
The CSRT device consists of a floor-mounted mat that contains six plates (32 X 13cm): two base plates on which the participant stands and four target plates. A computer monitor displays a corresponding image of the mat. One of the stepping plates on the computer image light up in a random order. The participant will be instructed to step on to the corresponding illuminated plate as quickly as possible, using their left foot for the targets to the left and to the front left, and their right for the targets to their right and front right. Reaction times for (i) time to lift the foot from the base plate and (ii) time to land the foot on target plate will be recorded. Each plate will be presented 5 times, and sufficient time will be given between each trial to re-establish balance and minimise fatigue.
Timepoint [5] 295931 0
Immediately before and after 6 minute testing for conditions A, B & C.
Secondary outcome [6] 295933 0
Jumping Test
Subjects remain in the same position as the static balance analysis. With the feet comfortably apart with one foot on each of the force plates, the subject is asked to jump as high as possible off both feet. If subjects feel they are unable to clear the ground with a jump due to lower limb weakness, they are asked to attempt a jump as best they can. The research physiotherapist will remain a close standby. Three (3) jumps will be recorded using both force plate and marker position data. This is a modified protocol from research investigating the association of muscle strength measures and falls risk in the elderly.
Timepoint [6] 295933 0
Immediately before and after 6 minute testing for conditions A, B & C.
Secondary outcome [7] 295934 0
Standing Balance
Standing balance will be measured while participants stand on two AMTI force plates. Postural position of C7 and sacrum will be measured using reflective markers and an 8-camera Vicon MX3 system. The participant will stand for 30 seconds under 4 conditions: (i) eyes open feet apart; (ii) eyes open feet together; (iii) eyes closed feet apart; and (iv) eyes closed feet together. Each condition will be repeated with the 8 trials presented in a randomized order
Timepoint [7] 295934 0
Immediately before and after 6 minute testing for conditions A, B & C.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284406 0
University
Name [1] 284406 0
Flinders University
Country [1] 284406 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
MS Australia
Address
Multiple Sclerosis Research Australia
PO Box 1246
Chatswood NSW 2057
Country
Australia
Secondary sponsor category [1] 283336 0
None
Name [1] 283336 0
Address [1] 283336 0
Country [1] 283336 0
Other collaborator category [1] 260519 0
University
Name [1] 260519 0
University of New South Wales
Address [1] 260519 0
Public Health and Community Medicine
Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country [1] 260519 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286507 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286507 0
Ethics committee country [1] 286507 0
Australia
Date submitted for ethics approval [1] 286507 0
Approval date [1] 286507 0
Ethics approval number [1] 286507 0
EC00191

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33553 0
Address 33553 0
Country 33553 0
Phone 33553 0
Fax 33553 0
Email 33553 0
Contact person for public queries
Name 16800 0
James McLoughlin
Address 16800 0
Rehab and Aged Care - C Block
Repatriation General Hospital
Daws Road
DAW PARK SA 5041
Country 16800 0
Australia
Phone 16800 0
+61 8 8275 1103
Fax 16800 0
+61 8 8275 1130
Email 16800 0
[email protected]
Contact person for scientific queries
Name 7728 0
James McLoughlin
Address 7728 0
Rehab and Aged Care - C Block
Repatriation General Hospital
Daws Road
DAW PARK SA 5041
Country 7728 0
Australia
Phone 7728 0
+61 8 8275 1103
Fax 7728 0
+61 8 8275 1130
Email 7728 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEffect of wearing a dorsiflexion assist orthosis on mobility, perceived fatigue and exertion during the six-minute walk test in people with multiple sclerosis: a randomised cross-over protocol2012https://doi.org/10.1186/1471-2377-12-27
N.B. These documents automatically identified may not have been verified by the study sponsor.