Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000994785
Ethics application status
Not yet submitted
Date submitted
3/09/2013
Date registered
5/09/2013
Date last updated
5/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Is walking really the best therapy for walking recovery after stroke?
Scientific title
Is the recovery of walking velocity and symmetry after stroke enhanced more by balance strength and coordination training than by treadmill training?
Secondary ID [1] 283129 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Walking recovery after stroke 289980 0
Condition category
Condition code
Stroke 290355 290355 0 0
Ischaemic
Stroke 290356 290356 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 290384 290384 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Walking rehabilitation using individualised balance, strength and coordination training conducted by a physiotherapist during 12 x 30-minute sessions over 4-weeks.
Simple equipment such as Therabands, chairs, and balls will be used for this training. The therapy will include both upper and lower limb tasks. Since each training session for each patient is conducted by a physiotherapist adherence will be inherent.
Intervention code [1] 287852 0
Rehabilitation
Comparator / control treatment
Walking rehabilitation using treadmill walking training supervised by a physiotherapist during 12 x 30-minute sessions over 4-weeks. The highest treadmill velocity each patient can safely maintain over a 20-30 minute period will be chosen.
Since each training session for each patient is conducted by a physiotherapist adherence will be inherent.
Control group
Active

Outcomes
Primary outcome [1] 290391 0
Fast self-selected walking speed using the 10 m walk test.
Timepoint [1] 290391 0
At two-month followup visit
Primary outcome [2] 290392 0
Depth of reciprocal inhibition between ankle effectors using 1 ms pulse-width suprathreshold electrical stimulation of an antagonist's mixed peripheral nerve on EMG recorded from weak tonic contraction of the agonist.
Timepoint [2] 290392 0
Two-month followup visit.
Secondary outcome [1] 304394 0
Stroke Specific Quality of Life Scale
Timepoint [1] 304394 0
Two-month followup visit
Secondary outcome [2] 304395 0
Spatiotemporal gait measures will be measured using a 5 m long GaitRite instrumented mat.
Timepoint [2] 304395 0
Two-month followup visit
Secondary outcome [3] 304396 0
TMS-conditioned H-reflexes measure the strength of conductivity between motor cortex and spinal circuits. Transcranial magnetic stimulation is delivered to the lower limb motor cortex at a point in time that allows the descending volley to arrive at the spinal cord circuitry when an H-reflex is being generated at the spinal cord level. H-reflexes are elicited in the soleus muscle using electrical stimulation of the posterior tibial nerve. The extent of modulation of the TMS conditioned H-reflex can be taken as a measure of cortex to spinal cord conductivity.
Timepoint [3] 304396 0
Two-month followup visit

Eligibility
Key inclusion criteria
Between 3 months and 2 years post-stroke
Overground gait velocity between 0.6 and 1.0 m/s

Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 3 months or greater than 2 years post-stroke
Patient receiving other walking therapy
Brain stem stroke
Orthopaedic conditions that would affect gait patterns
Co-morbidities that would restrict walking such as cardio-pulmonary disease and morbid obesity
Vision deficits, apraxia, or neglect that would be a barrier to training
Mini-Mental State Exam score < 20
Cognitive or communication deficits that preclude informed consent and study engagement
Contraindications to TMS

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)
The blinded assessing physiotherapist will randomise and minimise subjects into two groups using custom-written software. This allocation concealment process removes any bias to group randomisation and automates the balancing of independent variables.
Minimisation of the following variables will be achieved:
Gender
Age
Time-since-stroke (months)
Dichotomised self-selected overground walking velocity
Lower extremity Fugl-Meyer score
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted using a minimal clinically important difference in gait velocity of 0.16 m/s and a reported variance of 0.2 from the LEAPS study. With an alpha of 0.05 and a sample size of 20, the power was 0.95. Recruiting 25 for each group will allow for some dropout.
Data will first be assessed for normality using Kolmogorov-Smirnov tests. Baseline data (A1, A2, A3) will be assessed for significant pre-intervention group differences. Pre-intervention baseline data (A1, A2, A3) will be analysed with two-way mixed effects analyses of variance (time and group), and main effects will be investigated using Tukey’s HSD post hoc tests. Pre- to post-intervention and retention period data (A3, A4, A5, A6) will be analysed with mixed-effects analyses of variance (time and group). Main effects will be investigated using Tukey’s HSD post hoc tests. If baseline data do not reveal an effect of time, data will be collapsed across all three time-points, otherwise only the last baseline data will be used in the analysis of variance. Data that are not normally distributed will be analysed with Friedman tests for effects of time, and Mann-Whitney U tests for effects of group. A significance level of 0.5 will be adopted for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
27/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5355 0
New Zealand
State/province [1] 5355 0
Auckland

Funding & Sponsors
Funding source category [1] 287883 0
Charities/Societies/Foundations
Name [1] 287883 0
Applications pending to the Neurological Foundation of NZ
Country [1] 287883 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286610 0
None
Name [1] 286610 0
Address [1] 286610 0
Country [1] 286610 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289824 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 289824 0
Ethics committee country [1] 289824 0
New Zealand
Date submitted for ethics approval [1] 289824 0
14/10/2013
Approval date [1] 289824 0
Ethics approval number [1] 289824 0

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

Contacts
Principal investigator
Name 42598 0
Dr James Stinear
Address 42598 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 42598 0
New Zealand
Phone 42598 0
+64 9 3737599 ext 82378
Fax 42598 0
Email 42598 0
[email protected]
Contact person for public queries
Name 42599 0
James Stinear
Address 42599 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 42599 0
New Zealand
Phone 42599 0
+64 9 3737599 ext 82378
Fax 42599 0
Email 42599 0
[email protected]
Contact person for scientific queries
Name 42600 0
James Stinear
Address 42600 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 42600 0
New Zealand
Phone 42600 0
+64 9 3737599 ext 82378
Fax 42600 0
Email 42600 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.