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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

Date results information initially provided

23/09/2022

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]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Physical activity

Physical functioning

Self-efficacy

Condition category

Condition code

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

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]

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]

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]

Measurements of physical activity were collected throughout the whole rehabilitation period in each of 6 weeks.

Primary outcome [2]

Physical functioning (functional independence): Barthel Index for Activities of Daily Living (ADL) score

Timepoint [2]

Baseline (on admission) and at the completion of the 6-week rehabilitation.

Primary outcome [3]

Self-efficacy: Stroke Self-Efficacy Questionnaire score

Timepoint [3]

Baseline (on admission) and at the completion of the 6-week rehabilitation.

Secondary outcome [1]

Physical functioning (functional mobility): Timed Up and Go (TUG) score

Timepoint [1]

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]

Physical functioning (balance): Berg Balance Scale (BBS) score

Timepoint [2]

Baseline (on admission) and at the completion of the 6-week rehabilitation.

Secondary outcome [3]

Timepoint [3]

If the patient could walk without personal assistance, the measurement was provided after 6-weeks post rehabilitation.

Secondary outcome [4]

General self-efficacy: General Self-Efficacy Scale score

Timepoint [4]

Baseline (on admission) and at the completion of the 6-week rehabilitation.

Secondary outcome [5]

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]

Baseline (on admission) and at the completion of the 6-week rehabilitation.

Secondary outcome [6]

Only in non-ambulatory patients: Trunk Control Test score

Timepoint [6]

Baseline (on admission) and at the completion of the 6-week rehabilitation.

Secondary outcome [7]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Krakow/Modlniczka/Krzeszowice

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Physical Education in Krakow

Address [1]

78 Jana Pawla II Avenue
Krakow
31-571
Poland

Country [1]

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]

University

Name [1]

University of Physical Education in Krakow at the Faculty of Rehabilitation

Address [1]

78 Jana Pawla II Avenue
Krakow
31-571
Poland

Country [1]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics Committees at the Regional Chamber of Physicians in Krakow

Ethics committee address [1]

11 A Krupnicza Street
Krakow
31-123
Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

10/07/2018

Ethics approval number [1]

127/KBL/OIL/2018

Summary

Brief summary

The aim of the study was to explore dynamics change of physical activity (PA), psychological and functional outcomes and correlation between them in patient during early or chronic in-patient post-stroke rehabilitation. Two separate groups of patients during inpatient rehabilitation participated independently in the research project. One group consisted of non-ambulatory patients during early rehabilitation phase (<3 month from stroke onset). The second group consisted of patients in chronic phase (>6 month from stroke onset), who could walk, but only with orthopaedic aid (like cane, quad cane, crutch, walker) Methods: All participants were measured at baseline (1) and 6 weeks post (2) conventional rehabilitation with Barthel Index (BI), Berg Balance Scale (BBS), Trunk Control Test (TCT) Stroke Impact Scale (SIS), General Self-Efficacy Scale (GSES), Stroke Self-Efficacy Questionnaire (SSEQ), original scale of belief in own impact on recovery (BiOIoR), Hospital Anxiety and Depression Scale (HADS), Acceptance of Illness Scale (AIS) and when patient could walk- Time Up & Go and 6 Minute Walk Test. Daily PA was assessed over 6 weeks using Caltrac accelerometer. All results were analysed with within-group comparison, separately for early non-ambulatory stoke patients, and separately for chronic walking with aid stroke patients.

Trial website

n/a

Trial related presentations / publications

Public notes

Despite the extensive literature on stroke rehabilitation, there is little studies that comprehensively show non-ambulatory stroke patients. The aim of the study was to explore dynamics change of physical activity (PA), psychological and functional outcomes and correlation between them in non-ambulatory patient during early in-patient post-stroke rehabilitation.

Contacts

Principal investigator

Name

Mr 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

Country

Poland

Phone

+48 604249436

Fax

[email protected]

Contact person for public queries

Name

Mr 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

Country

Poland

Phone

+48 604249436

Fax

[email protected]

Contact person for scientific queries

Name

Mr 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

Country

Poland

Phone

+48 604249436

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
1332	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Physical Activity, Psychological and Functional Outcomes in Non-Ambulatory Stroke Patients during Rehabilitation-A Pilot Study.	2022	https://dx.doi.org/10.3390/jcm11247260

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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