Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000245493
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
22/02/2016
Date last updated
22/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of cognitive and motor dual task on gait performance and brain activities in individuals with stroke
Scientific title
Effects of cognitive and motor dual task on gait performance and brain activities in individuals with stroke
Secondary ID [1] 288324 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 297289 0
Condition category
Condition code
Stroke 297486 297486 0 0
Haemorrhagic
Stroke 297490 297490 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The walking conditions included walking at a normal pace and walking while performing a second cognitive or motor task. Gait performance and brain hemodynamics were recorded simultaneously during each walking condition.
*Normal-pace walking (NW): Participants were asked to walk at their normal pace on a 4.75*0.89 m walkway (GAITRite system, CIR system, Inc., Havertown, PA, USA) from one end to another, and to turn at the end of walkway and continue walking (for 60 s) until instructed to rest.
*Walking while performing a cognitive task (WCT): Participants were asked to walk on the same walkway while serially subtracting 3 from an initial 3-digit number and speaking out each calculated number as quickly as possible. The walking period was 60 seconds and ended with a rest.
*Walking while performing a motor task (WMT): Participants were asked to walk on the same walkway while carrying a tray with a bottle of water. Participants were asked to avoid dropping the bottle while walking. The walking period was 60 seconds and ended with a rest.
Each walking condition was repeated 2 times to yield a total of 6 walking trials (60 s for each) with random order.And 1 minute break between each 60 second trial. Approximate total duration of the test session was 15 minutes.
Intervention code [1] 293619 0
Not applicable
Comparator / control treatment
normal-pace walking (NW) condition
Control group
Active

Outcomes
Primary outcome [1] 297047 0
Speed, assessed by GAITRite system.
Timepoint [1] 297047 0
measurement throughout each 60 second test condition.
Primary outcome [2] 297343 0
Cadence, assessed by GAITRite system.
Timepoint [2] 297343 0
measurement throughout each 60 second test condition.
Primary outcome [3] 297344 0
stride length, assessed by GAITRite system.
Timepoint [3] 297344 0
measurement throughout each 60 second test condition.
Secondary outcome [1] 319916 0
brain activities in prefrontal cortex, premotor cortex, supplementary motor cortex assessed by functional near-infrared spectroscopy (fNIRS). (composite )
Timepoint [1] 319916 0
continuous measurement throughout about 20 minute test condition
Secondary outcome [2] 320764 0
stride time, assessed by GAITRite system.
Timepoint [2] 320764 0
measurement throughout each 60 second test condition.
Secondary outcome [3] 320765 0
dual task cost = (dual-task walking speed – single-task walking speed)/single-task walking speed * 100%. And the dual task cost was assessed by GAITRite system.
Timepoint [3] 320765 0
measurement throughout each 60 second test condition.
Secondary outcome [4] 320766 0
Temporal asymmetry ratio = absolute value[1-(single support time (affected))/(single support time (unaffected))]. And the Temporal asymmetry ratio was assessed by GAITRite system.
Timepoint [4] 320766 0
measurement throughout each 60 second test condition.
Secondary outcome [5] 320767 0
Spatial asymmetry ratio = absolute value[1-(step length (affected))/(step length (unaffected))]. And the Spatial asymmetry ratio was assessed by GAITRite system.
Timepoint [5] 320767 0
measurement throughout each 60 second test condition.

Eligibility
Key inclusion criteria
(1) hemiparesis from a single stroke, (2) able to walk independently without an assistive device with gait velocity at least reached limited community walking ability (58 cm/s) by Perry et al’s classification system, (3) able to use both upper extremities to hold a tray to complete the assessment, (4) Stable medical condition to allow participation in the testing protocol, and (5) a score of >24 on the mini-mental state examination (MMSE).
Minimum age
28 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
had any neurologic or orthopedic diseases that might interfere with the study

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The repeated one way ANOVA was used to analyze the effects of dual task on gait performance and brain activities. The significant level was set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/10/2013
Date of last participant enrolment
Anticipated
Actual
14/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 7525 0
Taiwan, Province Of China
State/province [1] 7525 0
Taipei

Funding & Sponsors
Funding source category [1] 292690 0
Government body
Name [1] 292690 0
Ministry of Science and Technology
Country [1] 292690 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang Ming University
Address
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C
Country
Taiwan, Province Of China
Secondary sponsor category [1] 291412 0
None
Name [1] 291412 0
Address [1] 291412 0
Country [1] 291412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294163 0
Institutional Review Board, Taipei Veterans General Hospital
Ethics committee address [1] 294163 0
Ethics committee country [1] 294163 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294163 0
20/05/2013
Approval date [1] 294163 0
05/08/2013
Ethics approval number [1] 294163 0
2013-08-017A

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

Contacts
Principal investigator
Name 62754 0
Miss Yan-ci, Liu
Address 62754 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 62754 0
Taiwan, Province Of China
Phone 62754 0
+886988525068
Fax 62754 0
Email 62754 0
[email protected]
Contact person for public queries
Name 62755 0
Ray-yau, Wang
Address 62755 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 62755 0
Taiwan, Province Of China
Phone 62755 0
+886928231905
Fax 62755 0
Email 62755 0
[email protected]
Contact person for scientific queries
Name 62756 0
Ray-yau, Wang
Address 62756 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 62756 0
Taiwan, Province Of China
Phone 62756 0
+886928231905
Fax 62756 0
Email 62756 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
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