Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000225415
Ethics application status
Approved
Date submitted
21/12/2015
Date registered
18/02/2016
Date last updated
18/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The cognitive and motor dual task gait training can result in beneficial effects on dual task gait performance in individuals with stroke – a pilot study
Scientific title
Effects of cognitive and motor dual task training on gait performance in individuals with stroke – a pilot study
Secondary ID [1] 288201 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke
297113 0
Condition category
Condition code
Stroke 297350 297350 0 0
Haemorrhagic
Stroke 297819 297819 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the cognitive dual task group were instructed to perform cognitive tasks while walking on level surface. The cognitive dual tasks included: (1) walking with repeating phrases, (2) walking with counting number forward in order by 1's, (3) walking with counting number backward in order by 1’s, (4) walking with executing a word chain (solitaire), (5) walking with reciting a poem, (6) walking with talking, and (7) walking with reciting a sentence backward. Various practice for the walking condition involved walking forward, walking backward, and walking on an S-shaped route. The participant was challenged with increasingly difficult tasks.
Participants in the motor dual task group were instructed to perform motor tasks while walking on the level surface. The motor dual tasks included: (1) walking while holding 1 or 2 balls (diameter = 20 cm), (2) walking while raising an umbrella by both hands, (3) walking while waving a rattle, (4) walking while beating a castanet, (5) walking while bouncing a basketball (diameter = 24.6 cm), (6) walking while kicking a basketball which was put in a net, and the net was held by the participant, and (7) walking while holding 1 ball and concurrently kicking another basketball in a net. Various practice for the walking condition involved walking forward, walking backward, and walking on an S-shaped route. The participant was challenged with increasingly difficult tasks.
Participants in the control group received the conventional physical therapy, including muscle strengthening, balance, and gait training programs.
All the intervention period was 30 min per session, 3 sessions per week for 4 weeks. And it was individual face-to-face sessions with a physiotherapist.
Intervention code [1] 293503 0
Rehabilitation
Intervention code [2] 293907 0
Treatment: Other
Comparator / control treatment
Participants in the control group received the conventional physical therapy, including muscle strengthening, balance, and gait training programs.The intervention was 30 min per session, 3 sessions per week for a total of 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 296906 0
The gait speed during cognitive and motor dual task walking and single walking used the 1 minute walking test and assessed by GAITRite system.
Timepoint [1] 296906 0
Baseline and post-intervention (4 weeks)
Primary outcome [2] 297341 0
The cadence during cognitive and motor dual task walking and single walking used the 1 minute walking test and assessed by GAITRite system.
Timepoint [2] 297341 0
Baseline and post-intervention (4 weeks)
Primary outcome [3] 297342 0
The stride length during cognitive and motor dual task walking and single walking used the 1 minute walking test and assessed by GAITRite system.
Timepoint [3] 297342 0
Baseline and post-intervention (4 weeks)
Secondary outcome [1] 319673 0
dual task cost = (dual-task walking speed – single-task walking speed)/single-task walking speed * 100%. And the dual task cost used the 1 minute walking test and assessed by GAITRite system.
Timepoint [1] 319673 0
Baseline and post-intervention (4 weeks)
Secondary outcome [2] 320763 0
The stride time during cognitive and motor dual task walking and single walking. And the stride time used the 1 minute walking test and assessed by GAITRite system.
Timepoint [2] 320763 0
Baseline and post-intervention (4 weeks)

Eligibility
Key inclusion criteria
(1) hemiparesis from a single stroke either ischaemic stroke and haemorrhagic stroke, (2) gait velocity at least reached limited community walking ability (58 cm/s) by Perry et al’s classification system, (3) able to walk 10m independently without an assistive device, (4) able to use non-affected upper extremities to hold a tray to complete the assessment, (5) stable medical condition to allow participation in the testing protocol and intervention, and (6) a score of >24 on the mini-mental state examination (MMSE).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) patient with any comorbidity or disability other than stroke that would preclude gait training, (2) any uncontrolled health condition for which exercise was contraindicated, and (3) any neurologic or orthopedic diseases that might interfere with the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/10/2013
Date of last participant enrolment
Anticipated
Actual
24/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 7478 0
Taiwan, Province Of China
State/province [1] 7478 0
Taipei

Funding & Sponsors
Funding source category [1] 292595 0
Government body
Name [1] 292595 0
Ministry of Science and Technology
Country [1] 292595 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang Ming University
Address
No.155, Sec. 2, Linong St., Beitou Dist., Taipei City 112, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 291625 0
None
Name [1] 291625 0
None
Address [1] 291625 0
None
Country [1] 291625 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294076 0
Institutional Review Board, Taipei Veterans General Hospital
Ethics committee address [1] 294076 0
Ethics committee country [1] 294076 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 294076 0
Approval date [1] 294076 0
19/07/2013
Ethics approval number [1] 294076 0
2013-07-028B

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

Contacts
Principal investigator
Name 62350 0
Prof Ray-Yau, Wang
Address 62350 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 62350 0
Taiwan, Province Of China
Phone 62350 0
+886928231905
Fax 62350 0
Email 62350 0
[email protected]
Contact person for public queries
Name 62351 0
Ray-Yau, Wang
Address 62351 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 62351 0
Taiwan, Province Of China
Phone 62351 0
+886928231905
Fax 62351 0
Email 62351 0
[email protected]
Contact person for scientific queries
Name 62352 0
Ray-Yau, Wang
Address 62352 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 62352 0
Taiwan, Province Of China
Phone 62352 0
+886928231905
Fax 62352 0
Email 62352 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.