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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12616000844448 |
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Date of registration:
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28/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An electromechanical gait trainer for ambulation training after stroke
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Scientific title:
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Efficacy and cost effectiveness of an electromechanical gait trainer for ambulation training after stroke in a Singaporean Community Hospital: a single blind randomised trial. |
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Date of first enrolment:
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03/06/2011 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12616000844448.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Ms Joyce Chua
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Address:
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St. Andrew's Community Hospital
8 Simei Street 3, Singapore529895
Singapore |
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Telephone:
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+65 65861000 |
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Email:
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joyce_chua@sach.org.sg |
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Affiliation:
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Name:
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Ms Joyce Chua
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Address:
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St. Andrew's Community Hospital
8 Simei Street 3, Singapore 529895
Singapore |
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Telephone:
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+65 65861000 |
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Email:
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joyce_chua@sach.org.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria were:
1) unilateral hemorrhagic/ischemic stroke
2) age 18-80 years
3) independent ambulation pre-stroke
Exclusion criteria: Exclusion criteria were:
1) >8 weeks post-stroke
2) Functional Ambulation Category (FAC) >4
3) Cardiovascular instability
4) Mini Mental State Examination (MMSE) <16
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Stroke;Ambulation;
Stroke
Ambulation
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Stroke - Haemorrhagic
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Stroke - Ischaemic
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Intervention(s)
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The electromechanical gait trainer (GT) is a gait training machine which uses 2 driven footplates to simulate the phases of gait. Participants would be put into this GT by two therapy assistants.
The GT group received 45 minutes of physiotherapy 6 times per week for 8 weeks, comprising 20 minutes of GT training, 5 minutes of stance/gait training, 10 minutes of standing and 10 minutes of cycling.
10 minutes of standing and 10 minutes of cycling were assisted by two TAs with the help of an alarm clock.
Each stance and gait training session was structured to be 5 minutes. It was delivered face-to-face individually by an experienced physiotherapist with at least 5 years of working experience in the neurological field. A progression of task difficulty in terms walking and dynamic standing balance was tailored to suit participants' capability.
There were no intervention adherence assessments by external parties.
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Primary Outcome(s)
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Cost effectiveness
Relative cost effectiveness of one treatment over the other was assessed as the difference in costs between treatments divided by the difference in health status outcomes between treatments.
Given the equivalence of clinical effectiveness, a cost-minimisation analysis was conducted to determine the most cost-effective option.
The cost of each treatment was calculated by identifying and estimating the staff and equipment costs required to undertake each procedure.
[Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.]
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Secondary Outcome(s)
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Health status was also measured with the Stroke Impact Scale (SIS) memory & thinking, mood and emotion, communication, participation & recovery. [Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks. ]
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Modified Barthel Index
This measures general independence in activity of daily function consisting of 10 items such as transfers, ambulation and stair climbing. It has a minimum score of 0 (completely dependent) to 100 (completely independent)[Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.]
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Functional ambulatory Categories.
This is a measure of gait ability. It is graded from 0 (non-ambulant) to 5 (independent ambulation). The participants walked a 15-m distance. If appropriate they will negotiate a short staircase with a rail.[Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.]
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Gait speed
The time taken to cover 10 meter on a level surface.[Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.]
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Gait endurance- 6 minute walk test[Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.]
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Health status was measured with the Stroke Impact Scale (SIS) physical component.[Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks. ]
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Secondary ID(s)
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NIL known
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Source(s) of Monetary Support
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St. Andrew's Community Hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
St. Andrew's Community Hospital Ethics Research Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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