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Trial registered on ANZCTR


Registration number
ACTRN12622000298718
Ethics application status
Approved
Date submitted
17/01/2022
Date registered
16/02/2022
Date last updated
28/10/2024
Date data sharing statement initially provided
16/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Searching for the missing element of rehabilitation - the influence of multimedia self-management intervention on selected psychological and functional aspects, and physical activity in non-ambulatory stroke patients in the early rehabilitation phase
Scientific title
The influence of multimedia self-management intervention on selected psychological and functional aspects, and physical activity in non-ambulatory stroke patients in the early rehabilitation phase: a randomized controlled pilot study
Secondary ID [1] 306128 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This project is a continuation of previous preliminary study registered with number ACTRN12619000226101.

Health condition
Health condition(s) or problem(s) studied:
Stroke 324804 0
Physical activity 324805 0
Physical functioning 324806 0
Self-efficacy 324807 0
Motivation for rehabilitation 324808 0
Depression 324810 0
Condition category
Condition code
Stroke 322254 322254 0 0
Ischaemic
Stroke 322255 322255 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 322256 322256 0 0
Physiotherapy
Physical Medicine / Rehabilitation 322257 322257 0 0
Other physical medicine / rehabilitation
Mental Health 322568 322568 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Project aim will be realized with three-arm parallel group randomized controlled trial. The study will be conducted during a 7-week period of the conventional, early post-stroke rehabilitation phase in two rehabilitation hospitals.

All groups will obtain the same rehabilitation with a one hour of physiotherapy for 5 days a week for 7 weeks and other usual care provided in rehabilitation centres. One week of rehabilitation will be dedicated to 3 measurement timepoints (each for two days). Multimedia self-management intervention will not be an additional therapy, but rather a tool to support standard rehabilitation during the normal course of rehabilitation. In this way, the total duration of the intervention in each group will be the same.

The experimental intervention (multimedia self-management intervention) will be implemented in two groups with a different onset, and the control group will receive only usual care, as below:
Arm 1: Control Group - will receive usual care during whole 6 weeks of rehabilitation;
Arm 2: Mixed Group (self-controlled) – usual care in first half (3 weeks) of rehabilitation and multimedia self-management intervention in the second half (3 weeks);
Arm 3: Experimental Group will receive multimedia self-management intervention (MSMI) - during whole 6 weeks of rehabilitation.

MSMI will be provided with a special, original mobile application. The application will be operated by physiotherapists on the tablets. MSMI will consist of three multimedia components.

1) Educational and motivational films
These films will integrally present both the mechanism of stroke, subsequent stages of improvement and neuroplasticity in combination with authentic rehabilitation recordings, whiteboard animation, interviews with professionals and stroke survivors. The movies through a simple message will show the importance of own activity from the neuroplasticity perspective. The films will also encourage the pursuit of independence at the current rehabilitation stage and gradual involvement in achieving once more difficult functional goals. The movies will be individually tailored to patient’s possibility as not to providing false hope. The patients will watch three videos on the tablet during the first two weeks of the experimental phase. The duration of the films will be from 5 to 15 minutes. Watched movies will be marked to monitor adherence.

2) Multimedia active goal-setting
The patient with the physiotherapist will firstly create the rehabilitation plan by dragging and dropping selected mobility activities icons as rolling to side, sitting up, standing up, walking or 20 others to the middle fields. Then they will set short and long term goal related to mobility that they want to achieve by proper designation of icons with flags. It will occur at the beginning of the fourth week in the Arm 2, and at the beginning of the first week of rehabilitation in the Arm 3. The plan will be established only once and possibly changed if necessary. The goal-setting will be multimedia presented in the context of the subsequent stages of rehabilitation. The application will allow setting up to 20 activity icons in the rehabilitation plan so that the patient will be able to monitor even the smallest progress and experience success more often. The multimedia goal-setting will be conducted in a face-to-face session of approximately 20 minutes. Application data including the number of steps and marked goals will be analyzed to monitor adherence and fidelity of MSMI.

3)Motivating multimedia self-monitoring.
Physiotherapists will record activities with the tablet (at least one recording per week) and record again when it will seem to improve. The patient with the physiotherapist will watch the comparative films. If they notice significant improvement, they will point the activity as successively achieved and the application will generate positive sounds and confetti. The physiotherapist will award in the application a MEDAL if the patient will perform the activity with minimal active help or assist, or a TROPHY if the patient will perform the activity safety and independently. In this way, participants will be able to reflect on their own personal successes, by achieving more and more advanced activity step by step. Application data including the number of recording and awards will be analyzed to monitor adherence and fidelity of MSMI.
Intervention code [1] 322558 0
Rehabilitation
Intervention code [2] 322791 0
Behaviour
Intervention code [3] 322792 0
Treatment: Devices
Comparator / control treatment
Arm 1: Control Group - will receive usual treatment consisted of general advice on exercise and physical activity as well as verbal education and motivation. Physiotherapists and psychologists will be instructed to verbally educate patients about stroke and rehabilitation and to motivate patients to exercise and self-activity just like before research project (usual care).
We still don’t have gold standard or established model of stroke support self-management with which we could compare experimental intervention. Because of that, standard approach that was used before the start of this research project will be conducted in control group.
Control group
Active

Outcomes
Primary outcome [1] 330020 0
Physical activity
Daily physical activity (PA) including the energy expenditure, level of intensity of physical effort and the time of activity or inactivity will be measuring with activity monitor ActiGraph wGT3X-BT.
Timepoint [1] 330020 0
Patients will wear ActiGraph on their waist 2 days a week from 9.00 to 18.00
throughout the whole 6 weeks rehabilitation period. Both the amount of PA and the dynamics of its change during the entire study period will be analysed.
Primary outcome [2] 330139 0
Physical functioning (functional independence): Barthel Index for Activities of Daily Living (ADL) score
Timepoint [2] 330139 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
There is no specific primary timepoint.
Primary outcome [3] 330140 0
Self-efficacy: Stroke Self-Efficacy Questionnaire score
In the control and experimental group the baseline and post-intervention will be the primary timepoint, and i mixed group all three timepoint will be primary.
Timepoint [3] 330140 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
There is no specific primary timepoint.
Secondary outcome [1] 405021 0
Physical functioning (balance): Berg Balance Scale (BBS) score
Timepoint [1] 405021 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [2] 405023 0
Physical functioning (trunk control): Trunk Control Test score
Timepoint [2] 405023 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [3] 405024 0
Physical functioning (walking endurance): 6 Minute Walk Test (6MWT) time
Timepoint [3] 405024 0
If the patient will able to walk: in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [4] 405025 0
Physical functioning (functional mobility): Timed Up and Go (TUG) score
Timepoint [4] 405025 0
If the patient will able to walk: in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [5] 405026 0
Motivation: Stroke Rehabilitation Motivation Scale score
Timepoint [5] 405026 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [6] 405027 0
Recovery locus of control: Recovery Locus of Control Scale score
Timepoint [6] 405027 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [7] 405028 0
In-depth semi-structured interviews based on study-specific questionnaire will be conducted during an approximately 20-minute face-to-face session:
qualitative analysis of issues related to rehabilitation such as goals, knowledge, commitment, perception of progress, and everyday life.
The interviewers will categorize the answers given by the patients during the interview, in a special interview sheet updated on the basis of subsequent interviews.
Timepoint [7] 405028 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [8] 405029 0
Feasibility: assessment of feasibility using an in-depth semi-structured interview and anonymous survey regarding the experience and opinion from participants, physiotherapists, and psychologists about usability, safety, and acceptability of the multimedia self-management intervention.
In-depth semi-structured interviews based on study-specific questionnaire will be conducted during an approximately 20-minute face-to-face session. The interviewer will categorize the answers during the interview, in a special interview sheet updated on the basis of subsequent interviews.
The anonymous survey will contain approximately 10 questions with answers on a 5-point Likert scale.
Timepoint [8] 405029 0
The interviews with the participants will be conducted at the end of experimental intervention (6 weeks post-intervention commencement).
The interviews and surveys with the practitioners will be provided at the end of the study (after recruiting and completing the intervention in the last patient (so as not to affect the approach and use of MSMI).
Secondary outcome [9] 405030 0
Safety: the number and type of adverse events and number of participants that withdrew from the study will be reported. Participants and practitioner will be asked to report any important observations and events.
A possible adverse event could be a fall, e.g. during transfers from a wheelchair to a bed, due to an increased self-efficacy in activity, or an epilepsy attack while watching educational and motivational films.
Timepoint [9] 405030 0
During the whole study, monitored continuously for the duration of the intervention, with the general analysis at the end of the study.
Secondary outcome [10] 405031 0
The risk of depressive and anxiety disorders: Hospital Anxiety and Depression Scale score
Timepoint [10] 405031 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks) and at the completion of the 6-week rehabilitation (post-intervention).

Eligibility
Key inclusion criteria
Inclusion criteria:
-clinical diagnosis of a ischemic or hemorrhage right or left hemisphere stroke; hemiparesis or hemiplegia;
-between one week up to 3 months after a last stroke;
-non-ambulatory status (patient who is unable to walk 10m in a flat corridor without active in the pre-enrollment test;
-able to walk about and not bedridden before last stroke;
-stable clinical condition and admission for early post-stroke inpatient rehabilitation under the National Health Fund;
-Mini-Mental State Examination score> 23, cognitive state allowing fully participating in the research project; ability to understand multimedia self-management intervention (inc. educational materials);
-age between 50 and 85 years;
-written consent for participation in the study.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
-significant perceptual, cognitive, or communication impairments;
-severe aphasia;
-dementia;
-deep depression;
-severe hemispatial neglect;
-ambulatory patient who could walk 10m or more independently in the pre-enrollment test;
-according to the assessment of a physician, a physiotherapist or a psychologist: all neurological, orthopaedic, rheumatological, internists, cognitive, and other conditions that could significantly affect the participation and results of the study, among others: tetraplegia, subarachnoid haemorrhage, traumatic brain injury, brain tumours, Parkinson's disease, multiple sclerosis.

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)
Allocation will be concealed. After qualifying for the research project, the participant will draw from a box one sealed opaque envelope with an assignment to the group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used so that all groups will contain equal numbers of participants and the proportion of allocation to groups will be similar in both rehebilitation centres. Each centre will receive a box of 9 or 6 randomly arranged sealed, opaque envelopes. In each 9 or 6- block, there will be 3 or 2 envelopes with the assignment to the control, mixed or experimental group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As there is no similar study, the sample size calculation for further study will be made on the basis of this study. Each group (control, mixed and experimental) will include 15 patients, for a total sample size of 45 participants. In the preliminary study (in which, due to technical reasons, it was not possible to implement an experimental intervention), 25% of patients did not finish the study. Therefore, it is planned to recruit 60 patients.
It is assumed that through the multifaceted, objective, quantitative and qualitative analysis of the results at three measurement points, it will be possible to draw reliable conclusions from the study.
Statistical analysis will be performed using STATISTICA 13.1. All calculations will be used with standard statistical significance (p <0.05). Descriptive statistics will be used to summarize participant characteristics on admission. Statistics test will depend on the distribution and nature of the variables obtained from the measurements. ANOVA could be used for repeated measures to model the treatment effects within-subject and between-subject. ActiGraph wGT3X-BT will capture and record high resolution raw acceleration data that will be converted with ActiLife v.6 into a variety of objective activity measures. Functional indicators could be used to characterize the continuous distribution of physical activity intensity as activity and sedentary bouts, time of inactivity, energy expenditure and more.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Based on the research observations and results analysis, it was decided that continuing the project would not contribute to an adequate expansion of knowledge in relation to patient involvement in the study.
Date of first participant enrolment
Anticipated
28/02/2022
Actual
17/02/2022
Date of last participant enrolment
Anticipated
3/06/2024
Actual
24/11/2023
Date of last data collection
Anticipated
8/01/2024
Actual
8/01/2024
Sample size
Target
60
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 24505 0
Poland
State/province [1] 24505 0
Modlniczka
Country [2] 24556 0
Poland
State/province [2] 24556 0
Krzeszowice

Funding & Sponsors
Funding source category [1] 310476 0
University
Name [1] 310476 0
University of Physical Education in Krakow
Country [1] 310476 0
Poland
Primary sponsor type
Individual
Name
Marcin Blaszcz
Address
University of Physical Education in Krakow
Doctoral School
Faculty of Rehabilitation: Institute of Clinical Rehabilitation
78 Jana Pawla II Avenue Krakow 31-571
Country
Poland
Secondary sponsor category [1] 311746 0
None
Name [1] 311746 0
Address [1] 311746 0
Country [1] 311746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310106 0
Bioethics Committees at the Regional Chamber of Physicians in Krakow
Ethics committee address [1] 310106 0
11 A Krupnicza Street Krakow 31-123
Ethics committee country [1] 310106 0
Poland
Date submitted for ethics approval [1] 310106 0
13/06/2018
Approval date [1] 310106 0
10/07/2018
Ethics approval number [1] 310106 0
127/KBL/OIL/2018

Summary
Brief summary
The aim of the project is to investigate the influence of the multimedia self-management intervention (MSMI) on physical activity, psychological and physical aspects in stroke patients. Project aim will be realized with three-arm parallel group randomized controlled trial. The study will be conducted during 7 weeks period of the conventional, early post-stroke rehabilitation phase in two rehabilitation hospitals.
The MSMI will be implemented in two groups with a different onset, and the control group will receive only usual care, as below:
Arm 1: Control Group - will receive usual care;
Arm 2: Mixed Group (self-controlled) – usual care in first half of rehabilitation and multimedia self-management intervention in the second half;
Arm 3: Experimental Group will receive multimedia self-management intervention - during whole rehabilitation.
MSMI will be provided with a special, original mobile application used in the tablet. The application will be operated by physiotherapists on tablets. MSMI will consist of three components.
1) Educational and motivational films
2) Multimedia active goal-setting
3)Motivating multimedia self-monitoring

Hypothesis:
By educating, planning the next stages of rehabilitation and visualizing progress, MSMI will improve:
-self-efficacy in activity and self-management,
-motivation in rehabilitation,
-and recovery locus of control.
Owing that, MSMI will improve daily amount and change over time of physical activity, and physical functioning and independence, and reduce the risk of depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116494 0
Mr Marcin Blaszcz
Address 116494 0
University of Physical Education in Krakow
Doctoral School
Faculty of Rehabilitation: Institute of Clinical Rehabilitation
78 Jana Pawla II Avenue Krakow 31-571
Country 116494 0
Poland
Phone 116494 0
+48 604249436
Fax 116494 0
Email 116494 0
[email protected]
Contact person for public queries
Name 116495 0
Marcin Blaszcz
Address 116495 0
University of Physical Education in Krakow
Doctoral School
Faculty of Rehabilitation: Institute of Clinical Rehabilitation
78 Jana Pawla II Avenue Krakow 31-571
Country 116495 0
Poland
Phone 116495 0
+48 604249436
Fax 116495 0
Email 116495 0
[email protected]
Contact person for scientific queries
Name 116496 0
Marcin Blaszcz
Address 116496 0
University of Physical Education in Krakow
Doctoral School
Faculty of Rehabilitation: Institute of Clinical Rehabilitation
78 Jana Pawla II Avenue Krakow 31-571
Country 116496 0
Poland
Phone 116496 0
+48 604249436
Fax 116496 0
Email 116496 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?
The data related to stroke, age, gender, all measurements (all outcome) will be shared on request.
When will data be available (start and end dates)?
The data will be available on request immediately following publication. No end date is determined.
Available to whom?
The data will be shared case-by-case basis at the discretion of primary sponsor.
Available for what types of analyses?
The data could be available for different purpose.
How or where can data be obtained?
The data will be shared via contact and approval by principal investigator at the e-mail address: [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



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