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Trial registered on ANZCTR


Registration number
ACTRN12616000844448
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
28/06/2016
Date last updated
28/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An electromechanical gait trainer for ambulation training after stroke
Scientific title
Efficacy and cost effectiveness of an electromechanical gait trainer for ambulation training after stroke in a Singaporean Community Hospital: a single blind randomised trial.
Secondary ID [1] 289303 0
NIL known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 299013 0
Ambulation 299014 0
Condition category
Condition code
Stroke 298972 298972 0 0
Ischaemic
Stroke 299069 299069 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294859 0
Treatment: Devices
Intervention code [2] 295009 0
Rehabilitation
Comparator / control treatment
The conventional physiotherapy group received 25 minutes of stance/gait training, 10 minutes of standing and 10 minutes of cycling. This was done 6 times per week for 8 weeks
Control group
Active

Outcomes
Primary outcome [1] 298435 0
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.

Timepoint [1] 298435 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.
Secondary outcome [1] 324126 0
Health status was measured with the Stroke Impact Scale (SIS) physical component.
Timepoint [1] 324126 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.
Secondary outcome [2] 324680 0
Health status was also measured with the Stroke Impact Scale (SIS) memory & thinking, mood and emotion, communication, participation & recovery.
Timepoint [2] 324680 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.
Secondary outcome [3] 324681 0
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.
Timepoint [3] 324681 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.
Secondary outcome [4] 324682 0
Gait speed
The time taken to cover 10 meter on a level surface.
Timepoint [4] 324682 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.
Secondary outcome [5] 324683 0
Gait endurance- 6 minute walk test
Timepoint [5] 324683 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.
Secondary outcome [6] 324684 0
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)
Timepoint [6] 324684 0
Measures were taken at baseline, 4, 8, 12, 24 and 48 weeks.

Eligibility
Key inclusion criteria
Inclusion criteria were:
1) unilateral hemorrhagic/ischemic stroke
2) age 18-80 years
3) independent ambulation pre-stroke
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

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)
Randomization to the 2 parallel groups ( GT and conventional physiotherapy) was performed in a 1:1 ratio using a computer-generated sequence of random numbers. An independent department generated the random group allocation sequence and transferred the sequence to a series of serially numbered opaque envelopes, which were not opened and revealed until after acceptance into the study and the baseline tests, therefore ensuring allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a computer-generated sequence of random number
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A Generalised Linear Model (Generalised Estimating Equations) analysis was carried out.
The study was powered for the primary outcome measure in the clinical effectiveness study (Chua et al. 2016): the proportions of patients in each group attaining a Functional Ambulation Category (FAC) >4, which represents independent ambulation with or without aids. Using an alpha of 0.05, a beta of 0.2 and data derived from Pohl et al (2007) on the FAC, a power analysis suggested a sample size of 42 in each group. Allowing for 20% drop-out, the target size for each group was 53 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7904 0
Singapore
State/province [1] 7904 0

Funding & Sponsors
Funding source category [1] 293680 0
Hospital
Name [1] 293680 0
St. Andrew's Community Hospital
Address [1] 293680 0
8 Simei Street 3, Singapore 529895
Country [1] 293680 0
Singapore
Primary sponsor type
Hospital
Name
St. Andrew's Community hospital
Address
8 Simei Street 3, Singapore 529895
Country
Singapore
Secondary sponsor category [1] 292514 0
None
Name [1] 292514 0
Address [1] 292514 0
Country [1] 292514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295120 0
St. Andrew's Community Hospital Ethics Research Committee
Ethics committee address [1] 295120 0
8 Simei Street 3, Singapore 529895
Ethics committee country [1] 295120 0
Singapore
Date submitted for ethics approval [1] 295120 0
03/05/2011
Approval date [1] 295120 0
01/06/2011
Ethics approval number [1] 295120 0

Summary
Brief summary
There is some evidence that electromechanical gait trainers (GT) combined with conventional physiotherapy may have equivalent or better efficacy than conventional physiotherapy alone when retraining ambulation in sub-acute stroke patients. However, no studies have measured effects on quality of life or health status, nor have they evaluated cost effectiveness
This study thus aimed to compare the efficacy and cost effectiveness of electromechanical gait trainers (GT) combined with conventional physiotherapy than conventional physiotherapy alone when retraining ambulation in sub-acute stroke patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66182 0
Ms Joyce Chua
Address 66182 0
St. Andrew's Community Hospital
8 Simei Street 3, Singapore 529895
Country 66182 0
Singapore
Phone 66182 0
+65 65861000
Fax 66182 0
Email 66182 0
joyce_chua@sach.org.sg
Contact person for public queries
Name 66183 0
Ms Joyce Chua
Address 66183 0
St. Andrew's Community Hospital
8 Simei Street 3, Singapore529895
Country 66183 0
Singapore
Phone 66183 0
+65 65861000
Fax 66183 0
Email 66183 0
joyce_chua@sach.org.sg
Contact person for scientific queries
Name 66184 0
Ms Joyce Chua
Address 66184 0
St. Andrew's Community Hospital
8 Simei Street 3, Singapore 529895
Country 66184 0
Singapore
Phone 66184 0
+65 65861000
Fax 66184 0
Email 66184 0
joyce_chua@sach.org.sg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary