Trial Review

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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
7/10/2022
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity, psychological and functional outcomes in early non-walking and chronic walking with aid stroke patients during rehabilitation- a pilot study
Scientific title
Physical activity, psychological and functional outcomes in early non-walking and chronic walking with aid stroke patients during rehabilitation- a 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
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
It is a prospective observational pilot study involving consecutive stroke patients who were qualified for early or chronic post-stroke in-patient rehabilitation to rehabilitation hospital.
All participants underwent conventional rehabilitation included individualized sessions of physiotherapy, speech, occupational, and psychological therapy and other usual care provided in rehabilitation hospitals. Rehabilitation was carried out 5 days a week (with additional shorter therapy at Saturday) for 6 weeks. Physiotherapy lasted around 1 hour and consisted of neurophysiological methods and mobility, functional, balance and arm training.
In this observational study the following research activities were conducted:
an overview of the information collected, e.g. medical history; measurements of physical activity, psychological and functional outcomes.
For the observational data collection, to assess physical activity, participants wear Caltrac accelerometer in each of 6 weeks from morning to evening. Psychologists provided questionnaires twice, on admission and after 6 weeks of rehabilitation in face to face form, usually for two days (2 separate visit for around 30 minutes). Physiotherapists provided functional assessment twice, on admission and after 6 weeks of rehabilitation in direct form. Medical history was collected from medical records during multiple visits in rehabilitation hospital.
The observation lasted from Apriill 2019 and August 2021. Data coding and data operations to database finished at May 2022. Data analysis and interpretation finished at August 2022.
Intervention code [1] 313424 0
Rehabilitation
Comparator / control treatment
All participants underwent conventional rehabilitation included individualized sessions of physiotherapy, speech, occupational, and psychological therapy and other usual care provided in rehabilitation hospitals. Rehabilitation was carried out 6 days a week for 6 weeks. Physiotherapy lasted around 1 hour and consisted of neurophysiological methods and mobility, functional, balance and arm training.
There was no comparison between study groups.
Control group
Uncontrolled

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 were collected throughout the whole rehabilitation period in each of 6 weeks.
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) and at the completion of the 6-week rehabilitation.
Primary outcome [3] 318832 0
Self-efficacy: Stroke Self-Efficacy Questionnaire score
Timepoint [3] 318832 0
Baseline (on admission) and at the completion of the 6-week rehabilitation.
Secondary outcome [1] 366003 0
Physical functioning (functional mobility): Timed Up and Go (TUG) score
Timepoint [1] 366003 0
In early non-ambulatory group: if the patient could walk without personal assistance, the measurement was provided after 6-weeks post rehabilitation.

In walking with aid chronic group: baseline (on admission) and at the completion of the 6-week rehabilitation.
Secondary outcome [2] 366196 0
Physical functioning (balance): Berg Balance Scale (BBS) score
Timepoint [2] 366196 0
Baseline (on admission) and at the completion of the 6-week rehabilitation.
Secondary outcome [3] 366228 0
In early non-ambulatory group: if the patient could walk without personal assistance, the measurement was provided after 6-weeks post rehabilitation.

In walking with aid chronic group: baseline (on admission) and at the completion of the 6-week rehabilitation.
Timepoint [3] 366228 0
If the patient could walk without personal assistance, the measurement was provided after 6-weeks post rehabilitation.
Secondary outcome [4] 366419 0
General self-efficacy: General Self-Efficacy Scale score
Timepoint [4] 366419 0
Baseline (on admission) and at the completion of the 6-week rehabilitation.
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) and at the completion of the 6-week rehabilitation.
Secondary outcome [6] 366423 0
Only in non-ambulatory patients: Trunk Control Test score
Timepoint [6] 366423 0
Baseline (on admission) and at the completion of the 6-week rehabilitation.
Secondary outcome [7] 414043 0
Belief in own impact on recovery (internal locus of control) with an original scale. The patients were asked to rank 5 different factors on which their recovery depends, from the most significant (5 point) to the least significant (1 point).
Timepoint [7] 414043 0
On admission (baseline) and 6-weeks post rehabilitation.

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
Sex
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
Duration
Selection
Timing
Statistical methods / analysis
The sample size was not achieved.
For the analysis of physical activity (PA), firstly, the median PA energy expenditure was calculated for each individual patient for each week. Secondly, the mean of the medians was calculated for each week (from 1st to 6th week). Only measurements from working days were included in analysis due to the frequent lack of data and not wearing Caltrac during the whole weekends. To assess the dynamics of PA changes, only the differences between consecutive weeks and between 1st and 6th week were analyzed. 6-repeated-measures analyses of variance (ANOVA) were used to compare difference in PA over time. F tests were followed by Bonferroni tests. In order to determine the strength of the effect, the partial eta-squared (?2P) was calculated.
All statistical analysis was performed with Statistica 13.1, except for PA and mediation analysis for which IBM SPSS Statistics ver. 26 was used. Descriptive measures are shown as mean (SD), Median, 95% confidence interval and frequency (percentage). The normality of data was verified using the Shapiro-Wilk test. For comparison de-pendent and independent variables with normal distribution Student's t-test was used. Wilcoxon signed-rank test and Mann-Whitney U test was performed for comparison of dependent and independent variables diverged from normal distribution, respectively. To determine the relationship between measurable variables with normal distribution the Pearson's correlation coefficient was used. Otherwise, the nonparametric Spearman rank order correlation coefficient was used. In the absence of a complete set of measurements (e.g. PA), available measurements were taken into account for analysis. In statistical analysis, missing data was removed in pairs. All calculations used standard statistical significance (p <0.05).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The design of the first part of the study assumed recruitment of participants only to the control group. Then, at the beginning of the 2022 recruitment to the mixed and experimental groups was planned. This schedule was to verify how the functioning of the entire cluster (patient, physiotherapist and psychologist) will be affected by the introduction of an experimental intervention. When designing the research methodology, it was assumed that the introduction of experimental intervention to the rehabilitation setting could change the treatment method also for patients in the control group. Due to fact the period of the covid pandemic coincided with the recruitment of patients to the control group, the project was completed earlier, inter alia, due to probable the disruptive impact of the pandemic on the outcomes of participants in the control group. In addition, opportunities have arisen to conduct a pilot study with better research tools and methodology. Ultimately, it was decided that it was not worth investing any further funds in the continuation of this project.
Date of first participant enrolment
Anticipated
4/03/2019
Actual
17/04/2019
Date of last participant enrolment
Anticipated
6/03/2023
Actual
19/07/2021
Date of last data collection
Anticipated
17/04/2023
Actual
Sample size
Target
60
Accrual to date
Final
48
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
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
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
Trial website
Trial related presentations / publications
Public notes

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
[email protected]
Contact person for public queries
Name 90243 0
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
[email protected]
Contact person for scientific queries
Name 90244 0
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
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1332Ethical approval    376796-(Uploaded-09-02-2019-08-02-05)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysical Activity, Psychological and Functional Outcomes in Non-Ambulatory Stroke Patients during Rehabilitation-A Pilot Study.2022https://dx.doi.org/10.3390/jcm11247260
N.B. These documents automatically identified may not have been verified by the study sponsor.