Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000620729
Ethics application status
Approved
Date submitted
24/05/2013
Date registered
30/05/2013
Date last updated
31/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Training standing up following stroke: a feasibility trial
Scientific title
Effect of specific feedback about foot placement on standing up performance in people following stroke: a feasibility trial
Secondary ID [1] 282528 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals following stroke in inpatient rehabilitation 289192 0
Condition category
Condition code
Stroke 289520 289520 0 0
Ischaemic
Stroke 289617 289617 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 289618 289618 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specific environmental biofeedback (physical target) for foot placement set up by the therapist during standing up training for 20-30 minutes duration, 5 times per week for 2 weeks.
Intervention code [1] 287192 0
Rehabilitation
Comparator / control treatment
Not applicable - single group feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289616 0
Standing up performance in the laboratory (quantitative):
Timed 5-sit-to-stands Test
Timepoint [1] 289616 0
Baseline and post intervention (2 weeks)
Primary outcome [2] 289666 0
Standing up performance in the laboratory (qualitative):
Therapist rating of patient standing up performance from video footage
Rated on a 100mm Visual Analogue Scale (VAS)
Timepoint [2] 289666 0
Baseline and post intervention (2 weeks)
Primary outcome [3] 289667 0
Standing up performance in real life:
Covert observation of standing up performance in non-therapeutic areas during usual activities of daily living on random occasions by trained staff
Rated on a dichotomous Yes/No scale regarding achievement of correct foot position for: 1. preparation for standing up; and 2. final standing.
Timepoint [3] 289667 0
Post-intervention (2 weeks)
Secondary outcome [1] 302873 0
Measurement of feasibility
Safety through recording of adverse events such as injurious falls, non-injurious falls, muscle soreness and/or fatigue.
Trial recruitment through calculation of the number of patients screened, eligible and enrolled.
Intervention and measurement through the time taken to administer, patient adherence with the intervention; and patient satisfaction through responses on a satisfaction survey.
Therapist satisfaction through responses on a satisfaction survey.
Timepoint [1] 302873 0
Post-intervention

Eligibility
Key inclusion criteria
People receiving rehabilitation following stroke in an inpatient rehabilitation unit with hemiplegia/hemiparesis.
Able to stand up without use of upper limbs or therapist assistance from a normal chair. Sufficient communication and cognition to follow instructions and participate in rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any barriers to taking part in a physical rehab program, insufficient cognition/language.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Single group feasibility study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
7/05/2015
Date of last data collection
Anticipated
Actual
25/05/2015
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 1038 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 6900 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 287313 0
University
Name [1] 287313 0
The University of Sydney
Country [1] 287313 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Discipline of Physiotherapy
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 286062 0
Hospital
Name [1] 286062 0
Rehabilitation, Aged and Community Care
ACT Health
Address [1] 286062 0
GPO Box 825
Canberra City ACT 2601.
Country [1] 286062 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289286 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 289286 0
ACT Health
GPO Box 825
Canberra City ACT 2601.
Ethics committee country [1] 289286 0
Australia
Date submitted for ethics approval [1] 289286 0
Approval date [1] 289286 0
17/10/2012
Ethics approval number [1] 289286 0
ETHLR.12.239
Ethics committee name [2] 289287 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [2] 289287 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Ethics committee country [2] 289287 0
Australia
Date submitted for ethics approval [2] 289287 0
Approval date [2] 289287 0
24/04/2013
Ethics approval number [2] 289287 0
2013/057

Summary
Brief summary
To determine the feasibility and efficacy of a 2 week intervention of specific biofeedback about foot placement during training of standing up in people following stroke.
Trial website
Trial related presentations / publications
Stanton R, Ada L, Dean CM, Preston E (2016) Effect of information feedback on training standing up following stroke: a pilot feasibility study Top Stroke Rehabil. 23(6):413-419.
Public notes

Contacts
Principal investigator
Name 40170 0
Prof Louise Ada
Address 40170 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe, NSW 1825
Country 40170 0
Australia
Phone 40170 0
+61 2 9351 9544
Fax 40170 0
Email 40170 0
[email protected]
Contact person for public queries
Name 40171 0
Ms Rosalyn Stanton
Address 40171 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe, NSW 1825
Country 40171 0
Australia
Phone 40171 0
+61 2 6174 5663
Fax 40171 0
Email 40171 0
[email protected]
Contact person for scientific queries
Name 40172 0
Prof Louise Ada
Address 40172 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe, NSW 1825
Country 40172 0
Australia
Phone 40172 0
+61 2 9351 9544
Fax 40172 0
Email 40172 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of information feedback on training standing up following stroke: A pilot feasibility study.2016https://dx.doi.org/10.1080/10749357.2016.1170322
N.B. These documents automatically identified may not have been verified by the study sponsor.