Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12611000629932
Ethics application status
Approved
Date submitted
31/05/2011
Date registered
21/06/2011
Date last updated
21/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of an enriched environment post stroke
Scientific title
Does the use of environmental enrichment following stroke increase activity levels: A feasibility study.
Secondary ID [1] 262283 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 267985 0
Condition category
Condition code
Neurological 268117 268117 0 0
Other neurological disorders
Stroke 268251 268251 0 0
Ischaemic
Stroke 268252 268252 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Environmental enrichment: Access to tasks and equipment aimed to increase physical, cognitive and social activity. Example, Nintendo Wii, music books, jigsaw puzzles. Patients have free access to these materials for the two week period of the intervention (and further if they remained an inpatient in the ward) to use at their discretion.
Intervention code [1] 266675 0
Not applicable
Comparator / control treatment
Typical rehabilitation environment (un enriched). Patients in the typical rehablitation environment recieve only traditional allied health therapies during working hours. There is no recreational therapy groups, or recreational or diversional therpist and patients are not provided with any material to occupy their time whilst not in therapy.
.All patients who were admitted to the rehabilitation ward for stroke rehabilitation were screened for eligability. Historical data was collected over a 2-3 week period for each patient who consented to participate in the study. The historical data was collected from the time period, 22nd April 2010 until 20th August 2010 in the rehabilitation facility, Rankin Park Centre, New Lambton, 2305.
Control group
Historical

Outcomes
Primary outcome [1] 266867 0
Activity levels: Proportion of the day spent in physical, cognitive and social activity (%). Behavioural mapping tool was used to estimate the proportion of time spent in each activity during 4, 12 hour days (1 weekday and 1 weekend day in the first week, with the same weekday and weekend day repeated 2 weeks later).
Behavioural mapping observations were made every ten minutes in which the location, people present and activity were noted for each participant.
Timepoint [1] 266867 0
Baseline and 2 weeks later.
Secondary outcome [1] 276528 0
Function (Functional Independence Measure),
Timepoint [1] 276528 0
Baseline and 2 weeks later
Secondary outcome [2] 276744 0
Cognitive Function (using a battery of tests including the Montreal Cognitive Assessment)
Timepoint [2] 276744 0
Baseline and 2-3 weeks later (control group, 2-3 week period), enrichment group, post enrichment period, which was usually again, a 2-3 week period from baseline assessments)
Secondary outcome [3] 276745 0
Qualitative interview to gain a further understanding of the patient's experience in rehabilitation (enriched group only)
Timepoint [3] 276745 0
Qualitative interview- end of 2 week enrichment period
Secondary outcome [4] 276746 0
Quality of Life (Assessment of Quality of Life (AQoL) survey
Timepoint [4] 276746 0
AQoL- approx one month post discharge from hospital
Secondary outcome [5] 276755 0
boredom (purposely designed likert survey)
Timepoint [5] 276755 0
Baseline and 2 weeks later
Secondary outcome [6] 276756 0
mood (PHQ-9)
Timepoint [6] 276756 0
Baseline and 2 weeks later

Eligibility
Key inclusion criteria
mRS > or equal to 2
able to follow one step commands
able to stand with the assistance of 2
no behavioural issues influencing the ability to participate in 'normal' rehabilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Becomes acutely unwell, preventing participation in the rehabilitation process

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267167 0
Charities/Societies/Foundations
Name [1] 267167 0
National Stroke Foundation of Australia
Country [1] 267167 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW
2308
Country
Australia
Secondary sponsor category [1] 266242 0
Hospital
Name [1] 266242 0
Rankin Park Centre
Address [1] 266242 0
Lookout Rd
New Lambton Heights
NSW
2289
Country [1] 266242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269156 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 269156 0
Ethics committee country [1] 269156 0
Australia
Date submitted for ethics approval [1] 269156 0
09/09/2009
Approval date [1] 269156 0
12/10/2009
Ethics approval number [1] 269156 0
09/09/16/5.08

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32680 0
Address 32680 0
Country 32680 0
Phone 32680 0
Fax 32680 0
Email 32680 0
Contact person for public queries
Name 15927 0
Heidi Janssen
Address 15927 0
THe Lodge Building
Lookout Rd
New Lambton Heights
NSW
2305
Country 15927 0
Australia
Phone 15927 0
+61 (0)411114995
Fax 15927 0
Email 15927 0
[email protected]
Contact person for scientific queries
Name 6855 0
Heidi Janssen
Address 6855 0
THe Lodge Building
Lookout Rd
New Lambton Heights
NSW
2305
Country 6855 0
Australia
Phone 6855 0
+61 (0)411114995
Fax 6855 0
Email 6855 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
No additional documents have been identified.