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Trial registered on ANZCTR


Registration number
ACTRN12620000769987
Ethics application status
Approved
Date submitted
12/03/2020
Date registered
27/07/2020
Date last updated
27/07/2020
Date data sharing statement initially provided
27/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of locomotive exercise therapy on individuals with Multiple Sclerosis
Scientific title
The effects of locomotive exercise therapy on EMG activity, step and stride length and EDSS on individuals with Multiple Sclerosis
Secondary ID [1] 299404 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
MS ABLE T Program.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Scelrosis 314580 0
Condition category
Condition code
Neurological 312922 312922 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The training program will consist of 36 ABLE-T training sessions per participant. Each participant will receive training three time per week of across 12 week period. Each session will consist of a warm-up of 20 assisted squats, followed by five times 3 minute intervals of step retrain and two 3 minute intervals of step adapt using the Therastride harness and treadmill system. Step retrain involves the continual increase in weight bearing while maintaining proper posture and positioning of standing by manual facilitation at trunk, pelvis and legs as needed. Step adapt promotes independence by varying the bodyweight support and treadmill speed. Each session is 60 minutes in duration. The harness will be used to reduce body weight and support the individual during the training session.The locomotor leg movements will be assisted by two trainers, each sitting at one side of the individual. For each training session, training variables will be recorded such as walking speed, amount of body weight support, duration of training and heart rate will be recorded.

Pre and post intervention, through the measurement of EMG activity, we will examine and provide physiological and neurological evidence on changes in neuroplasticity from the 12 weeks of locomotive exercise (ABLE-T programme) in individuals with Multiple Sclerosis. We will examine the correlation of these changes with step and stride length, 6 minute walk time, 10 m walk time and balance, which will provide secondary outcome measures which are integral components to assessing the effectiveness of our programme, also measured pre and post intervention.

Muscle activity assessment
Each participant will need to wear shorts. Whilst lying down, electrodes will be placed
on the upper and lower legs (bicep femoris, rectus femoris, tibialis anterior and
gastrocnemius). The equipment will then be calibrated to zero before proceeding with
maximal voluntary contractions (MVC). MVC are performed prior to testing to
provide a normalized reference point for each participant. The participants will put on
the Therastride harness and will complete two bouts of 3 minutes of assisted walking
(1 x bout at 0.5 mph and 1 x bout at 0.9 mph). Following this they will complete a
further assisted walk on the Therastride treadmill for 1 minute at a speed of 0.9mph,
where a segment of muscle activity will be recorded.

Step and stride length assessment
Step length is measure of left to right imbalance. You will be asked to walk for 10
steps. Each time your heel strikes the ground a mark will be placed at the heel. The
distance will be measured between left and right heel strikes.
Stride length is the distance between two successive placements of the same foot.
You will be asked to walk for 10 steps. Each time your left foot strikes the ground, a
mark will be placed at the heel. The distance will be measured between your left heel
strokes. You will be asked to repeat this on your right foot. The distance will be
measured between your right heel strokes.

Balance measurement
Balance will be assessed using the in-ground force plate. You will be asked to stand
on the force plate with the feet in a normal parallel position, with eyes open for up to 30 seconds. Second balance position is having the instep of one foot so it is touching the big toe of the other foot, with eyes open for up to 30 seconds. the final stance requires the stance of heel-to-toe with eyes open for up to 30 seconds.

10m Walk Test
This is a test of lower limb strength. You will be asked to walk 10m at a comfortable
speed. You can use mobility aids if required. The time taken from an average of 3
tests, is used to calculate gait speed.

6-minute walk test
The 6-minute walk test will assess your functional exercise capacity. Your blood
pressure and heart rate will be measured before the walk. You will be asked to walk
up and back long a 30m track for up to 6 minutes. The test can be reduced to 2
minutes if you are finding this difficult. During the test, you are allowed to stop and
rest. You can also use mobility aids if required. Your heart rate will also be measured
following completion of the walking test.

Testing and training will commence at Massey University in The Human Performance Lab and locomotive training room. All testing will be done with one participant, the lead investigator and assistant and the training will include 2 more assistants.
Intervention code [1] 316956 0
Rehabilitation
Intervention code [2] 317232 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323054 0
The primary outcome is the effects of locomotive exercise on EMG activity this will be assessed via electrodes on the biceps femoris, rectus femoris, tibialis anterior and gastrocnemius and will allow us to measure neuroplasticity.

Timepoint [1] 323054 0
This will be assessed pre and post ABLE-T program. 12 weeks apart.
Primary outcome [2] 323436 0
The primary outcome is the effects of locomotive exercise on balance. Balance will be assessed with the tandem and semi-tandem stance
Timepoint [2] 323436 0
This will be assessed pre and post ABLE-T program. 12 weeks apart.
Secondary outcome [1] 380620 0
We will also examine the correlation of these changes with step length
which will provide secondary outcome measures which are integral components to assessing the effectiveness of our programme.
Step length is a measure of lower limb strength and a good indication of left to right imbalances between the lower limbs. It is a simple procedure where the tester marks the heel placement of each foot for ten consecutive steps.
These measurements will be taken using a measuring tape and chalk.
Timepoint [1] 380620 0
Pre and post intervention, 12 weeks apart
Secondary outcome [2] 381935 0
We will also examine the correlation of these changes with Stride length. Stride length is the measurement of length between two successive placements of the same foot. The distance measured is from one heel leaving the ground to the same heel leaving the ground (consisting of two steps). The individual takes three to four strides marking the left heel only and then repeating the same procedure with the right heel. These measurements will be taken using a measuring tape and chalk.
Timepoint [2] 381935 0
Pre and post intervention, 12 weeks apart
Secondary outcome [3] 381941 0
10minute walk test
This is a test of lower limb strength. You will be asked to walk 10m at a comfortable
speed. You can use mobility aids if required. The time taken from an average of 3
tests, is used to calculate gait speed.
Timepoint [3] 381941 0
Pre and post intervention, 12 weeks apart
Secondary outcome [4] 381942 0
Force Plate measurements of balance
Balance will be assessed using the inground force plate. You will be asked to stand
on the force plate with the feet in a normal parallel position, with eyes open for up to 30 seconds, secondly with the instep of one foot so it is touching the big toe of the other foot, with eyes open for up to 30 seconds and thirdly In the stance of heel-to-toe with eyes open for up to 30 seconds.
Timepoint [4] 381942 0
Pre and post intervention, 12 weeks apart
Secondary outcome [5] 381944 0
The 6-minute walk test will assess your functional exercise capacity. Your blood pressure and heart rate will be measured before the walk. You will be asked to walk up and back long a 30m track for up to 6 minutes. The test can be reduced to 2 minutes if you are finding this difficult. During the test, you are allowed to stop and rest. You can also use mobility aids if required. Your heart rate will also be measured following completion of the walking test.
Timepoint [5] 381944 0
Pre and post intervention, 12 weeks apart

Eligibility
Key inclusion criteria
Six participants will be age, ethnicity and gender matched between the ages of 30 and 64 years, with primary progressive, or secondary progressive MS, an EDSS score of 6.0-8.0 and approval from a health care professional for exercise training and ability to visit the facility for the ABLE-T programme.
Minimum age
30 Years
Maximum age
64 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
An EDSS score lower then 6.0, younger then 30 or older the 64, and a health professional advising against participation.

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations are based upon the primary outcomes whereby the root mean square of the original rectified EMG profiles of the different step cycles for each training week will be determined. Previous studies examining locomotor training have used sample sizes between 4 and 6 participants. This pilot study will aim to use a sample size of 6. will achieve a power above 0.8, and statistical significance p<0.05. A sample size of >10 in the ABLE-T will not be feasible as participants will be attending Massey University, Palmerston North for up to 3 sessions per week which accounts for a maximum of 18-hours across the week for training.

A paired t-test will be used to test the statistical significance of the mean changes in RMS EMG, step and stride length, pre and post intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22397 0
New Zealand
State/province [1] 22397 0

Funding & Sponsors
Funding source category [1] 303911 0
University
Name [1] 303911 0
Massey University
Address [1] 303911 0
Massey University
School of Sport, exercise and nutrition
private bag 11-222
Palmerston North
4442
Country [1] 303911 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University
Research Ethics Office
private bag 11-222
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 304061 0
None
Name [1] 304061 0
Address [1] 304061 0
Country [1] 304061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304415 0
Health and disability Ethics Committee
Ethics committee address [1] 304415 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 304415 0
New Zealand
Date submitted for ethics approval [1] 304415 0
12/03/2020
Approval date [1] 304415 0
20/04/2020
Ethics approval number [1] 304415 0
20/CEN/84

Summary
Brief summary


ABLE-T program
The training program will consist of 36 ABLE-T training sessions per participant. Each participant will receive training three time per week of across 12 week period to retrain step and stride length and stand position. The objective is to note the changes locomotive training has on individuals with multiple sclerosis.

Hypothesis
A 12 week programme of ABLE-T training will improve EMG activity (neuronal
plasticity with corresponding motor recovery), will increase step and stride length, increase distance over 6 minutes, or a reduction in time to walk 10m and will improve balance.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96874 0
Dr Lynette Hodges
Address 96874 0
Massey University
School of Sport, Exercise and Nutrition
Private Bag 11-222
Palmerston North
4442
Country 96874 0
New Zealand
Phone 96874 0
+64 063569099
Fax 96874 0
Email 96874 0
l.d.hodges@massey.ac.nz
Contact person for public queries
Name 96875 0
Dr Lynette Hodges
Address 96875 0
Massey University
School of Sport, Exercise and Nutrition
Private Bag 11-222
Palmerston North
4442
Country 96875 0
New Zealand
Phone 96875 0
+64 063569099
Fax 96875 0
Email 96875 0
l.d.hodges@massey.ac.nz
Contact person for scientific queries
Name 96876 0
Dr Lynette Hodges
Address 96876 0
Massey University
School of Sport, Exercise and Nutrition
Private Bag 11-222
Palmerston North
4442
Country 96876 0
New Zealand
Phone 96876 0
+64 063569099
Fax 96876 0
Email 96876 0
l.d.hodges@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
anonymous data of participants will be shared, results of tests and training data
When will data be available (start and end dates)?
April 2021 onwards
Available to whom?
Case by Case basis
Available for what types of analyses?
For future research use on Multiple sclerosis and locomotive. as this is a pilot study the aim would be to conduct a greater study based off the results and data of the pilot study.
How or where can data be obtained?
From Massey University, via email of Lynette Hodges l.d.hodges@massey.ac.nz
What supporting documents are/will be available?
No other documents available
Summary results
No Results