Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000201875
Ethics application status
Approved
Date submitted
10/02/2012
Date registered
17/02/2012
Date last updated
17/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical stimulation for foot drop in people with multiple sclerosis (MS)
Scientific title
Training Effect of Peroneal Nerve Stimulation on Fatigue Induced Gait Variability in People with Multiple Sclerosis.
Secondary ID [1] 279903 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue induced gait in people with mutiple sclerosis 285811 0
Condition category
Condition code
Neurological 285988 285988 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will wear a commercially available peroneal nerve stimulator (NessL300) for 8 weeks. The first 3 weeks will consist of training and acclimatisation to the device, starting at 15 minutes per day, building up to 8 hours of use per day. They will then continue to use the device as an orthosis for the next 5 weeks using it for 8 hours per day. All participants will be provided with a 3 week training sheet that explains how long they wear the device for each day.
Intervention code [1] 284227 0
Treatment: Devices
Comparator / control treatment
Not applicable, there is no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286489 0
6 Minute Walking Test
The subject will then 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 subject walking unaided up and down a 12m 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 subjects rating of perceived exertion (RPE) using the modified Borg scale (Borg, 1982). Subjects are permitted to slow down, stop and rest as necessary. Heart Rate will be continually monitored throughout the 6MWT.
Timepoint [1] 286489 0
- Baseline
- Week 8
- Week 12
Primary outcome [2] 286490 0
Gait Kinematics
3D gait analysis using 8 camera Vicon System.
Timepoint [2] 286490 0
- Baseline
- Week 8
- Week 12
Secondary outcome [1] 296007 0
10 Metre Walking Test
This part involves the subject walking along a 10m designated path 6 times. The walk will be timed as the 10 metre Walk Test (10MWT). Information will be automatically collected with video, 3D analysis and force plate data. The subject will do this with the FES device on, and repeat with the Functional Electircal Simulation Device off.
Timepoint [1] 296007 0
- Baseline
- Week 8
- Week 12
Secondary outcome [2] 296008 0
Timed Up and Go
The timed get up and go test is a measurement of mobility. It includes a number of tasks such as standing from a seating position, walking, turning, stopping, and sitting down which are all important tasks needed for a person to be independently mobile.
Timepoint [2] 296008 0
- Baseline
- Week 8
- Week 12
Secondary outcome [3] 296009 0
Static Balance Analysis
The experiment will begin with the subject standing on a force plate while measurements are taken under 4 conditions; feet together (~0.5cm apart) eyes open, feet together (~0.5cm apart) eyes closed, feet apart (~10 cm apart) eyes open, feet apart (~10 cm apart) eyes closed. For safety there will be a close standby throughout this procedure and each block will consist of 30 seconds data collection. Data will be obtained from a reflective marker on C7 vertebra as well as the force plates. The order of these balance conditions will be randomised and each condition will be assessed three times (Ramdharry, Marsden, Day, & Thompson, 2006).
Timepoint [3] 296009 0
- Baseline
- Week 8
- Week 12
Secondary outcome [4] 296010 0
Physiological Cost of Walking (PCI) from heart rate
Timepoint [4] 296010 0
- Baseline
- Week 8
- Week 12
Secondary outcome [5] 296011 0
Perceived exertion when walking (Modified Borg Scale)
Timepoint [5] 296011 0
- Baseline
- Week 8
- Week 12
Secondary outcome [6] 296012 0
Visual Analogue Scale for Fatigue
Perceived Fatigue from Walking
Timepoint [6] 296012 0
- Baseline
- Week 8
- Week 12
Secondary outcome [7] 296013 0
Muscle strength of Quadriceps and Dorsiflexors
The subject will be seated, and a strain gauge will be strapped to their shin at one end and attached to the back of the chair at the other. They will be asked to extend their leg as hard as they can. The strain gauge will record the strength of the movement. The subject will then have their foot strapped into a foot rest, with a strain gauge attached. They will be asked to raise their foot by bending their ankle. The strain gauge will again record the strength of the movement. Each of the two strength tests will be repeated 3 times, with a one minute rest between each attempt.
Timepoint [7] 296013 0
- Baseline
- Week 8
- Week 12
Secondary outcome [8] 296014 0
Step Count
The Bioness L300 has a in built pedometer which counts the steps. The data is downloadable is a steps per day format.
Timepoint [8] 296014 0
- Baseline
- Week 8
- Week 12
Secondary outcome [9] 296015 0
12 Item MS Walking Scale
Timepoint [9] 296015 0
- Baseline
- Week 8
- Week 12
Secondary outcome [10] 296020 0
Fatigue Severity Scale
Timepoint [10] 296020 0
- Baseline
- Week 8
- Week 12

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
- Able to walk 100m without the use of walking aids
- Notice difficulty clearing one foot more than the other when stepping, which worsens the further they walk
- Ability to understand instructions and give informed consent
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
- Regularly use an AFO with walking
- A demand-type pacemaker, defibrillator or any electrical or metallic implant
- A cancerous lesion is present or suspected
- Presence of regional disorders, such as a fracture or dislocation, which would be adversely affected by motion from the stimulation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited from an existing study determining the effect of fatigue on gait and balance. The subjects will be selected based on the investigators interpretation of their suitability for use of the FES device.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284691 0
Charities/Societies/Foundations
Name [1] 284691 0
International Society of Prosthetics and Orthotics
Country [1] 284691 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
ADLEAIDE SA 5001
Country
Australia
Secondary sponsor category [1] 283592 0
None
Name [1] 283592 0
Address [1] 283592 0
Country [1] 283592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286676 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286676 0
Ethics committee country [1] 286676 0
Australia
Date submitted for ethics approval [1] 286676 0
01/06/2010
Approval date [1] 286676 0
24/06/2010
Ethics approval number [1] 286676 0
1/10/0202

Summary
Brief summary
This research study aims to test how effective the BioNessL300 is on fatigue induced gait variability in people with MS. In this study participants will wear a commercially available peroneal nerve stimulator (NessL300) for 8 weeks. The first 3 weeks will consist of training and acclimatisation to the device, starting at 15 minutes per day, building up to 8 hours of use per day. Participants will then continue to use the device as an orthosis for the next 5 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33752 0
Address 33752 0
Country 33752 0
Phone 33752 0
Fax 33752 0
Email 33752 0
Contact person for public queries
Name 16999 0
Chris Barr
Address 16999 0
Rehabilitation, Aged and Extended Care
Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 16999 0
Australia
Phone 16999 0
+61 8 8275 1103
Fax 16999 0
+61 8 8275 1130
Email 16999 0
[email protected]
Contact person for scientific queries
Name 7927 0
Chris Barr
Address 7927 0
Rehabilitation, Aged and Extended Care
Flinders University
GPO Box 2100
ADELAIDE SA 5001
Country 7927 0
Australia
Phone 7927 0
+61 8 8275 1103
Fax 7927 0
+61 8 8275 1130
Email 7927 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
No additional documents have been identified.