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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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000298718
Enrollment
26
Registered
2022-02-16
Start date
2022-02-17
Completion date
2023-11-24
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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). Multim

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.

Sponsors

Marcin Blaszcz
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026