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Trial registered on ANZCTR


Registration number
ACTRN12619000226101
Ethics application status
Approved
Date submitted
9/02/2019
Date registered
18/02/2019
Date last updated
21/02/2020
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of novel multimedia educational and motivational system in post-stroke rehabilitation — an original pilot study.
Scientific title
The impact of the implementation of the multimedia educational and motivational system to standard rehabilitation on self-efficacy, physical activity and functioning in stroke patients — an original pilot study.
Secondary ID [1] 297220 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 311196 0
Physical activity 311266 0
Physical functioning 311267 0
Self-efficacy 311268 0
Condition category
Condition code
Stroke 309816 309816 0 0
Ischaemic
Physical Medicine / Rehabilitation 309892 309892 0 0
Physiotherapy
Physical Medicine / Rehabilitation 310107 310107 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation of the multimedia educational and motivational system (MEMS) to standard post-stroke rehabilitation. Three arm pilot study:
Arm 1: Control Group -only verbal education and motivation;
Arm 2: Mixed Group (self-controlled) – first half of rehabilitation- verbal education and motivation – second half - MEMS (MEMS is experimental intervention treatment);
Arm 3: Experimental Group- MEMS (experimental intervention) whole rehabilitation.

The study will be carried out at the same time and independently in the two rehabilitation centres, in two separate post-stroke phases – at early (until 3 months) and chronic (>6 months) rehabilitation phase and in two patients’ functional status at baseline (non-ambulatory and ambulatory).

Why:
Every year, about 16 million people worldwide suffer a stroke. Of these 5 million become disabled. Every second patient, after leaving the rehabilitation centre, does not undertake even moderate physical activity. Even patients with minor stroke, despite the absence of significant motor disorders, reduce their previous recreational activities from 24 to 47%. Many patients have a little sense of control over recovery after stroke. Intentional involvement in physical activity as a support for recovery is often unknown. In turn, convictions about the cause of stroke, recovery, expectation or attitude to physical activity influence motivation. Consecutively, the patient's motivation and awareness can support participation in high repetitive task-oriented training and physical activity that promotes neuroplasticity. Also, education could increase patient’s physical activity. In turn, multimedia interactions combined with conversation can have a positive effect on motivation and reduction of depression in stroke patients. There are also evidences that self-efficacy could influence quality of life or perceived health status, depression, activities of daily living, and to a certain extent, physical functioning in stroke patients. However, few promising self-efficacy, self-management, motivational and educational interventions were found. Because of that, these interventions and programs promoting self-efficacy and physical activity in stroke patients need to be developed and studied.
The aim of this pilot study is to examine the safety and feasibility of the original multimedia educational and motivational system for stroke patients and trial approach that is intended to be used in a larger scale study.

What, who provided, how, when and how much:
All participants (each of 3 arms) will receive 6-weeks (5 days/week) standard post-stroke rehabilitation, that is a basic therapy.
Standard post-stroke rehabilitation will be consisted of individualized complex approach such as physiotherapy (strengthening and motor-control exercises, functional tasks and training for balance and walking), speech, psychological and occupational therapy. Standard rehabilitation in all patients is focused on the patient's own activity and improvement of everyday activities.

Experimental treatment is original multimedia educational and motivational system (MEMS) which will be implicated to standard rehabilitation at the beginning (Arm 3) and after half (Arm 2) of rehabilitation period.

MEMS consists of two elements:
1. EDUCATIONAL AND MOTIVATIONAL FILM SERIES:
the films present in an accessible and attractive way how a stroke occurs and how physiotherapy influences the neuroplasticity of the brain, thanks to which stroke patients regain their lost functions and skills. The films present the successive stages of rehabilitation (recovery of independence). The films have a very positive effect. Their goal is to make the patient aware how much he/she can do for his/her own fitness and functioning. Another message of the films is the pursuit of independence at the current stage of rehabilitation and the gradual involvement in achieving once more difficult functional goals.

Patients watch educational and motivational films together with a physiotherapist or psychologist during an individual session once a week on a tablet or TV screen in rehabilitation centre, which gives 6 sessions in experimental group and 3 in mixed group.

2. RECORDING AND MONITORING PROGRESSIONS OF THERAPY:
at the beginning patients, together with the physiotherapist, set a realistic goal. Thereafter, physiotherapists (with the consent of the patient) record physiotherapy with the tablet at the beginning and subsequent stages of rehabilitation. When the new skill is acquired, the physiotherapist records the re-test and the patient watches the comparative film (key moments of rehabilitation). The pre-and post-test test is displayed simultaneously. For example, a base test - the patient stands unsteadily for 30 seconds. Test after 2 weeks - the patient stands confidently, alone 2 minutes. The patient simultaneously watch 2 images that show his/her functional progress, that could motivate to further intensive physiotherapy and self-treatment.

Tailoring:
MEMS- films and progressions recording are personalized adjusted to patients functional status and goal.
Intervention code [1] 313424 0
Rehabilitation
Intervention code [2] 313471 0
Treatment: Other
Intervention code [3] 313472 0
Behaviour
Comparator / control treatment
All participants from each of the three group will be covered by standard 6-weeks rehabilitation.

Arm 1: Control Group -only verbal education and motivation. Participants in control group will receive only usual treatment consisted only of general advice on exercise and physical activity. Physiotherapists and psychologists are instructed to educate patients about the etiology and consequences of stroke and the improving possibility and to motivate patients to independent exercise and self-therapy.

Arm 2: Mixed Group (self-controlled)– firstly half of rehabilitation- verbal education and motivation – second half - MEMS. Participants in mixed group will receive only usual treatment consisted of general advice on exercise and physical activity and verbal education for first half (three weeks) of rehabilitation. Then, during second half (remaining three weeks) to mixed group rehabilitation the multimedia educational and motivational system will be implicated. Mixed group will act as their own control group.
Control group
Active

Outcomes
Primary outcome [1] 318776 0
Daily physical activity assessed using Caltrac accelerometer (calories used during physical activity). Caltrac is hip-mounted mechanical portable accelerometer allowing detecting movement. Daily measurement will be carried out and note from the ‘calories used’ activity mode by the physiotherapists during whole rehabilitation period (except for weekends that will be measured together)
Timepoint [1] 318776 0
Measurements of physical activity will be collected throughout the whole rehabilitation (intervention) period.
3 periods will be compared between control and experimental group (Arm 1 and 3):
1. First 3 weeks of intervention (rehabilitation);
2. Second 3 weeks of intervention (4th, 5th and 6th rehabilitation week);
3. Whole intervention period (6-week rehabilitation).

In mixed group (Arm 2):
first 3 weeks of intervention (rehabilitation) will be compared with second 3 weeks of intervention. Mixed group will act as their own control group.
Primary outcome [2] 318777 0
Physical functioning (functional independence): Barthel Index for Activities of Daily Living (ADL) score
Timepoint [2] 318777 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Primary outcome [3] 318832 0
Self-efficacy: Stroke Self-Efficacy Questionnaire score
Timepoint [3] 318832 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [1] 366003 0
Physical functioning (functional mobility): Timed Up and Go (TUG) score
Timepoint [1] 366003 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [2] 366196 0
Physical functioning (balance): Berg Balance Scale (BBS) score
Timepoint [2] 366196 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [3] 366228 0
Physical functioning (walking endurance): 6 Minute Walk Test (6MWT) time (when patient could walk)
Timepoint [3] 366228 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [4] 366419 0
General self-efficacy: General Self-Efficacy Scale score
Timepoint [4] 366419 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [5] 366420 0
Perception of recovery (strength, hand function, activities of daily leaving (ADL)/Instrumental ADL, mobility, communication, emotion, memory and thinking, and participation): Stroke Impact Scale score
Timepoint [5] 366420 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [6] 366422 0
Feasibility: Assessment of feasibility will be composite of experience and opinion from participants, physiotherapists and psychologists about system usability, safety and acceptability.of the multimedia educational and motivational
Timepoint [6] 366422 0
At the end of the study (not to affect practitioner approach in order to avoid bias) there will be collected descriptive data from the patients and practitioners think-aloud protocol and interviews.
Secondary outcome [7] 366423 0
Only in non-ambulatory patients: Trunk Control Test score
Timepoint [7] 366423 0
Baseline (on admission), in the mid-rehabilitation (after 3 weeks- only Mixed group) and at the completion of the 6-week rehabilitation (post-intervention).
Secondary outcome [8] 366466 0
Safety: The number and type of adverse events and number of participants that withdrew from the study will be reported. There are no known adverse events from using educational and motivational system. Perhaps, frustration due to lack of achieving goals / improvements could be possible adverse events, Participants and practitioner will be asked to report any important observations and events.
Timepoint [8] 366466 0
During whole study.

Eligibility
Key inclusion criteria
The inclusion criterion for all subjects (non-ambulatory and ambulatory): hemiparesis (ischaemic stroke of the right or left hemisphere of the brain); age between 50 and 85 years; providing informed, written consent for participation in a research experiment; patients discharged from the neurological / stroke unit with a stable clinical condition allowing participating in the research protocol and without significant cognitive impairment and dementia (Mini-Mental State Examination score> 23 points).

Criteria for two separate functional groups (from two different centres):
Functional criteria for non-ambulatory patient:
• in the early phase (up to 3 months) after a stroke.
• maintaining the sitting position independently for at least 30 seconds, but patients able to perform an independent (unassisted) transfer to the wheelchair are excluded.

Functional criteria for ambulatory patient:
• in the chronic phase (more than 6 months after a stroke);
• able to walk at least 10 m with orthopaedic support or assistance, but patients walk completely independently (including without any orthopaedic help or assistance) are excluded.
Minimum age
50 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Based on the evaluation performed by psychologist, patients with insufficient cognitive functions to acquire knowledge from educational films and / or monitor their own progress and / or to use physiotherapists' instructions are excluded.
Other exclusion criteria severe mixed or sensory aphasia, dementia according to MMSE=<23, intellectual disability, significant cognitive disorders or hemispatial neglect.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a mixed method pilot study. There will be 3 arms in both 2 centres (functional groups), what gives 6 groups (non-ambulatory -3 arm: control, mixed and experimental group and ambulatory -3 arm: control, mixed and experimental group. This will help set participants group, who will be more sensitive to be influenced by MEMS in randomized control trial in the future. There will be comparison between control and experimental groups and separate in mixed group (self-controlled).
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
It is planned to recruit about 5 patients for each of the six groups, which makes 30 participants in total.
Because, that is a pilot study the sample size could have not enough statistical power.
Statistical analysis will be performed with STATISTICA.
The total amount of energy expenditure (physical activity) at the 6-weeks evaluation: the frequency of the activity over time will be measured by the Caltrac. Descriptive statistics will be used to summarize participant characteristics on admission. ANOVA will be used for repeated measures to model the treatment effects with a within-subject and between-subject factor at baseline, mid-rehabilitation (only Mixed group) and post-treatment,. There also will be linked comparison between subjects from two different centres (different functional status and stroke phase) based on percentage of improvements (% of improvements in non-ambulatory+ambulatory experimental group vs control group). Separate statistical analysis will be performed for mixed group (self-controlled).
All calculations will be used with standard statistical significance (p <0.05).
Feasibility and safety of experimental intervention (multimedia educational and motivational system) will be assessed by qualitative methods using think-aloud protocol and interviews with the participants, physiotherapists and psychologists and amount of withdrawn from the experimental treatment.

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] 21219 0
Poland
State/province [1] 21219 0
Krakow/Modlniczka/Krzeszowice

Funding & Sponsors
Funding source category [1] 301717 0
University
Name [1] 301717 0
University of Physical Education in Krakow
Address [1] 301717 0
78 Jana Pawla II Avenue
Krakow
31-571
Poland
Country [1] 301717 0
Poland
Primary sponsor type
Individual
Name
Marcin Blaszcz
Address
University of Physical Education in Krakow at the Faculty of Rehabilitation,
Department of Clinical Rehabilitation
Doctoral studies
78 Jana Pawla II Avenue
Krakow
31-571
Poland
Country
Poland
Secondary sponsor category [1] 301654 0
University
Name [1] 301654 0
University of Physical Education in Krakow at the Faculty of Rehabilitation
Address [1] 301654 0
78 Jana Pawla II Avenue
Krakow
31-571
Poland
Country [1] 301654 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302438 0
Bioethics Committees at the Regional Chamber of Physicians in Krakow
Ethics committee address [1] 302438 0
11 A Krupnicza Street
Krakow
31-123
Poland
Ethics committee country [1] 302438 0
Poland
Date submitted for ethics approval [1] 302438 0
Approval date [1] 302438 0
10/07/2018
Ethics approval number [1] 302438 0
127/KBL/OIL/2018

Summary
Brief summary
The aim of the project is to determine whether the implementation of the original multimedia educational and motivational system (consisting of video education in the field of autotherapy and neuroplasticity and video monitoring of therapy progressions) to standard rehabilitation in stroke patients will influence their daily physical activity, physical functioning (independence, balance and gait), self-efficacy and recovery.

This pilot study is in preparation for a future randomised controlled trial designed to assess the effects and feasibility of original multimedia educational and motivational system (MEMS) for post-stroke rehabilitation.

There are three arms in this pilot study:
Arm 1: Control Group -only verbal education and motivation;
Arm 2: Mixed Group (self-controlled) – first half of rehabilitation- verbal education and motivation – second half - MEMS (MEMS is experimental intervention treatment);
Arm 3: Experimental Group- MEMS (experimental intervention) whole rehabilitation.

The study will be carried out at the same time and independently in the two rehabilitation centers, in two separate post-stroke rehabilitation phase – at early (until 3 months) and chronic (>6 months) and at two different patients’ functional status at baseline (non-ambulatory and ambulatory patients).
Trial website
n/a
Trial related presentations / publications
Public notes
The aim of the project is to determine whether the implementation of the original multimedia educational and motivational system (consisting of video education in the field of autotherapy and neuroplasticity and video monitoring of therapy progressions) to standard rehabilitation in stroke patients will influence their daily physical activity, physical functioning (independence, balance and gait), self-efficacy and recovery.

This pilot study is in preparation for a future randomised controlled trial designed to assess the effects and feasibility of original multimedia educational and motivational system (MEMS) for post-stroke rehabilitation.

There are three arms in this pilot study:
Arm 1: Control Group -only verbal education and motivation;
Arm 2: Mixed Group (self-controlled) – first half of rehabilitation- verbal education and motivation – second half - MEMS (MEMS is experimental intervention treatment);
Arm 3: Experimental Group- MEMS (experimental intervention) whole rehabilitation.

The study will be carried out at the same time and independently in the two rehabilitation centers, in two separate post-stroke rehabilitation phase – at early (until 3 months) and chronic (>6 months) and at two different patients’ functional status at baseline (non-ambulatory and ambulatory patients).

Contacts
Principal investigator
Name 90242 0
Mr Marcin Blaszcz
Address 90242 0
University of Physical Education in Krakow at the Faculty of Rehabilitation,
Department of Clinical Rehabilitation
Doctoral studies
78 Jana Pawla II Avenue
Krakow
31-571
Country 90242 0
Poland
Phone 90242 0
+48 604249436
Fax 90242 0
Email 90242 0
marcinblaszcz@gmail.com
Contact person for public queries
Name 90243 0
Mr Marcin Blaszcz
Address 90243 0
University of Physical Education in Krakow at the Faculty of Rehabilitation,
Department of Clinical Rehabilitation
Doctoral studies
78 Jana Pawla II Avenue
Krakow
31-571
Country 90243 0
Poland
Phone 90243 0
+48 604249436
Fax 90243 0
Email 90243 0
marcinblaszcz@gmail.com
Contact person for scientific queries
Name 90244 0
Mr Marcin Blaszcz
Address 90244 0
University of Physical Education in Krakow at the Faculty of Rehabilitation,
Department of Clinical Rehabilitation
Doctoral studies
78 Jana Pawla II Avenue
Krakow
31-571
Country 90244 0
Poland
Phone 90244 0
+48 604249436
Fax 90244 0
Email 90244 0
marcinblaszcz@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study, which aim is to assess the study protocol and safety and feasibility of treatment.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1332 0
Ethical approval
Citation [1] 1332 0
Link [1] 1332 0
Email [1] 1332 0
Other [1] 1332 0
Summary results
No Results