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Trial registered on ANZCTR


Registration number
ACTRN12620000107921
Ethics application status
Approved
Date submitted
15/11/2019
Date registered
6/02/2020
Date last updated
30/06/2021
Date data sharing statement initially provided
6/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of combined rehabilitation and motor imagery on balance in the subacute stroke: a randomized controlled study.
Scientific title
Use of implicit motor imagery for postural control and balance improvement in subacute stroke: a randomized controlled study.
Secondary ID [1] 299818 0
Nil known
Universal Trial Number (UTN)
U1111-1243-5894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 315197 0
rehabilitation 315198 0
Condition category
Condition code
Stroke 313511 313511 0 0
Haemorrhagic
Stroke 313512 313512 0 0
Ischaemic
Physical Medicine / Rehabilitation 313513 313513 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An initial data collection will be carried out for each patient (posturography, Berg test; Barthel index; Time up and go test; ECVI-38 quality of life questionnaire).

For the posturographic analysis, the Satel PF8C posturograph will be used, three repetitions of the Romberg test with open eyes and stable surface will be performed for 60 seconds, from which the repetition data with the best score in the sweep area will be collected. The full version of the Berg test and the Time up and Go test will be administered to evaluate the postural control, static and dynamic balance of each subject, and the Barthel index to assess the level of activity of the subjects. In addition, ECVI-38 questionnaire will be delivered for each participant to complete. This evaluation will be performed by the principal investigator.

Once the initial data is obtained, all participants will undergo 5 rehabilitstion sessions per week of forty minutes each, in which their own neurological rehabilitation techniques will be applied in order to restore the patient's previous functional level. These techniques were carried out by professionals trained in neurorehabilitation with proven experience of at least 3 years. The sessions will be held for a period of 4 weeks until 20 sessions are completed.

EG: The experimental group will hold 3 sessions per week of use of the Recognise® Flashcards on the recognition of the left / right laterality in images of feet in different positions added to rehabilitation sessions. 3 series of 20 different images will be presented in which the subject will identify whether it is a left or right member. A total of 12 sessions will be held with the help of a physiotherapist to perform laterality training; between each series a minute of rest will be left to correct the task. During the 8 restorative sessions, only rehabilitation will be performed.
All sessions will last 40 mimutes plus the time it takes for each individual to complete the task with Flascards.

Four weeks after the start of the intervention, the same variables were evaluated to analyze possible differences both intragroups and intergroups.

All these interventions will be carried out in the Rehabilitation Service of the Rey Juan Carlos University Hospital, in Móstoles, Spain.

The material that will be used in the intervention will be the Recognize flashcards designed by the Neuro Orthopedic Institute (NOI group) and designed for “the recognition, discrimination and restoration between the right and left trial at the cortical level for patients suffering from chronic pain”. This group bases the application of this program on the knowledge that prolonged chronic pain over time causes plastic changes in areas of the brain related to body schema and movement.
Intervention code [1] 316076 0
Rehabilitation
Intervention code [2] 316077 0
Treatment: Devices
Comparator / control treatment
CG: The control group will also hold 3 weekly sessions of use of the Recognize® Flashcards for a task of recognition of body parts (in which other images of feet, shoulders, neck, back and hands are included) in which they should only indicate which part of the body is treated 20 images will be presented in three series with a minute of rest between repetitions. A physical therapist will supervise the completion of the proposed task during the 12 sessions.
Control group
Active

Outcomes
Primary outcome [1] 321966 0
Changes in the sweep area (mm2) produced by the oscillation of the pressure center during the performance of the Romberg test with open eyes and stable surface, evaluated with the Satel PF8C posturograph.
Timepoint [1] 321966 0
Baseline, at four weeks after intervention commencement
Primary outcome [2] 321967 0
Changes in Berg Scale score
Timepoint [2] 321967 0
Baseline, at 4 weeks after intervention commencement
Primary outcome [3] 321968 0
Changes in Time up ang Go test
Timepoint [3] 321968 0
Baseline, at four weeks after intervention commencement
Secondary outcome [1] 376837 0
quality of life assessed using the ECVI-38 Quality of Life Questionnaire
Timepoint [1] 376837 0
Baseline, at at 4 weeks after intervention commencement
Secondary outcome [2] 376838 0
Changes in the percentage of load difference between both lower limbs, determined by the coordinates of the pressure center related to the average position when performing the Romberg test in Satel PF8C posturograph.
Timepoint [2] 376838 0
Baseline, at four weeks after intervention commencement
Secondary outcome [3] 376839 0
Changes inthe length of the oscillations (mm) produced by the subject during the 60-second test of roomberg in Satel PF8C posturograph.
Timepoint [3] 376839 0
Baseline, at four weeks after intervention commencement
Secondary outcome [4] 376840 0
Changes in Barthel Index
Timepoint [4] 376840 0
Baseline, at four weeks after intervention commencement

Eligibility
Key inclusion criteria
1) first stroke within the previous year;
2) over 18 years;
3) ability to maintain steady standing for 1 minute without supports;
4) sensorimotor disturbance that occurs with hemiparesis secondary to the stroke and alteration of the gait pattern.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) medical history of another neurological pathology other than stroke;
2) subjects with cognitive disorders that impede adherence to the intervention (score in Mini Cognitive Exam (MEC-35) greater or equal to 23)
3) subjects with significant alterations in language comprehension that impede adherence to the intervention (score in the auditory comprehension subtest of the Boston test below the 35th percentile);
4) subjects with comorbid pathology that prevented the performance of intensive rehabilitation;
5) subjects with impaired gait pattern prior to stroke;
6) subjects with visual disturbances that prevent the use of work material.

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)
Subjects will be randomly assigned to a group using random numbers generated by a computer. The person responsible for the randomization is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample calculation was obtained using the Power / Sample Size Calculator program.
To determine this value, the results obtained by the study by Ortuño-Cortés and Martín-Sanz (2008) have been used, which use the scan area obtained in the Romberg test with eyes open by the NedSVE / IBV posturograph as a result measure .
A 95% confidence interval (a 0.05) and a power of 80% have been taken; the resulting sample size is 54 subjects.
The sample of this study will be larger than the sample size obtained to compensate for the 15% that has been anticipated of possible dropouts, so the sample will be composed of 31 subjects in the experimental group and 31 subjects in the control group; with a total sample size n = 62 subjects.

It will be assessed if the data samples follow a normal distribution through the Shapiro-Wilk test.
Once the normality hypothesis has been verified, intragroup statistics will be performed, using the t-Student test for related samples in those variables that follow a normal distribution, and the non-parametric Wilcoxon test for those variables that do not follow a normal distribution.
To verify the superiority of the intergroup results, a comparison of means between the experimental group and the control group will be made using the t-Student test for independent samples.
In all cases, those results whose p-value <0.05 will be considered statistically significant..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
4/03/2020
Date of last participant enrolment
Anticipated
31/01/2022
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
62
Accrual to date
27
Final
Recruitment outside Australia
Country [1] 22113 0
Spain
State/province [1] 22113 0
Madrid

Funding & Sponsors
Funding source category [1] 304278 0
Hospital
Name [1] 304278 0
Rey Juan Carlos Hospital
Country [1] 304278 0
Spain
Funding source category [2] 304280 0
Self funded/Unfunded
Name [2] 304280 0
Noelia Díaz
Country [2] 304280 0
Spain
Primary sponsor type
Individual
Name
Noelia Díaz López
Address
Noelia Díaz López
Rey Juan Carlos Hospital; Rehabilitation Department
Gladiolo Street, s/n Móstoles (Madrid - Spain) PC 28933
Country
Spain
Secondary sponsor category [1] 304522 0
None
Name [1] 304522 0
Address [1] 304522 0
Country [1] 304522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304736 0
Rey Juan Carlos University Hospital Research Comittee
Ethics committee address [1] 304736 0
Gladiolo Street, s/n
Móstoles (Madrid - Spain) PC 28933
Ethics committee country [1] 304736 0
Spain
Date submitted for ethics approval [1] 304736 0
Approval date [1] 304736 0
13/10/2017
Ethics approval number [1] 304736 0

Summary
Brief summary
This study aims to determine the effectiveness of a complementary technique to physical therapy, easy to implement in the health system; that it does not require a great cost of learning both by professionals and by patients or caregivers; a safe and low-cost tool to improve rehabilitation and functional recovery times through the use of an implicit motor imagery program.
The study hypothesis would be the following: the work on the recognition of laterality in hemiparesic patients produces a statistically significant improvement in postural control and balance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98030 0
Miss Noelia Díaz López
Address 98030 0
Noelia Díaz López
Rey Juan Carlos Hospital; Rehabilitation Department
Gladiolo Street, s/n Móstoles (Madrid - Spain) PC 28933
Country 98030 0
Spain
Phone 98030 0
+34661936105
Fax 98030 0
Email 98030 0
[email protected]
Contact person for public queries
Name 98031 0
Noelia Díaz López
Address 98031 0
Noelia Díaz López
Rey Juan Carlos Hospital; Rehabilitation Department
Gladiolo Street, s/n Móstoles (Madrid - Spain) PC 28933
Country 98031 0
Spain
Phone 98031 0
+34661936105
Fax 98031 0
Email 98031 0
[email protected]
Contact person for scientific queries
Name 98032 0
Noelia Díaz López
Address 98032 0
Noelia Díaz López
Rey Juan Carlos Hospital; Rehabilitation Department
Gladiolo Street, s/n Móstoles (Madrid - Spain) PC 28933
Country 98032 0
Spain
Phone 98032 0
+34661936105
Fax 98032 0
Email 98032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Sociodemographic data of the subjects and study outcomes (Berg scale scores; quality of life scores; TUG test scores; Barthel Index scores for each participant)
When will data be available (start and end dates)?
The data will be available since the end of paper writing; there is no specific end date.
Available to whom?
Case-by-case basis at the discretion of primary sponsor
Available for what types of analyses?
Descriptive analysis
How or where can data be obtained?
Access subject to approvals by principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5693Informed consent form  [email protected] 378743-(Uploaded-14-11-2019-20-06-27)-Study-related document.docx
5694Ethical approval  [email protected] 378743-(Uploaded-14-11-2019-20-02-32)-Study-related document.pdf



Results publications and other study-related documents

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