Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000174583p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2023
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of two different types of Sit-to-stand Training Among Post-Stroke Individuals
Scientific title
The Effectiveness of the Part Practice Approach in Comparison to the Whole Practice Approach in Training Sit-To-Stand Among Post-Stroke Individuals
Secondary ID [1] 310906 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 331965 0
Condition category
Condition code
Stroke 328689 328689 0 0
Ischaemic
Stroke 328694 328694 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 329312 329312 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in the experimental group will practice the components of sit-to-stand (STS) movement, followed by STS training for 20 minutes, once a day 2 times a week for 8 weeks. Components of part-practice include backward foot placement followed by forward trunk bending, movement of the knees forward, and extension of hips and knees for final standing alignment. Each of these components will be practiced 10 times before doing sit-to-stand as a whole movement. Subjects will do the exercise in the Physiotherapy . Outpatient Department (OPD) of Hospital Rehabilitasi Cheras under the guidance of a trained Physiotherapist . Each of the treatment session will be a one-to-one session. Alternate allocation method will be used to allocate participants into an experimental or control group based on their age and disability level so that both group will have equal subjects with all age and disability level.
Intervention code [1] 327333 0
Rehabilitation
Comparator / control treatment
Subjects in the control group will be doing the Sit-to-Stand exercise for 20 minutes, once a day 2 times a week for 8 weeks. Subjects will do the exercise in the Physiotherapy Outpatient Department (OPD) of Hospital Rehabilitasi Cheras under the guidance of a trained Physiotherapist Each of the treatment session will be a one-to-one session. Alternate allocation method will be used to allocate participants into an experimental or control group based on their age and disability level so that both group will have equal subjects with all age and disability level.
Control group
Active

Outcomes
Primary outcome [1] 336506 0
Sit-to-stand performance
Timepoint [1] 336506 0
Baseline(before the treatment begin), 4 weeks(during the treatment), 8 weeks(at the completion of treatment), 12 weeks(1 month post intervention)
Primary outcome [2] 336507 0
Muscle strength (Hip and knee extensors)
Timepoint [2] 336507 0
Baseline(before the treatment begin), 4 weeks(during the treatment), 8 weeks(at the completion of treatment), 12 weeks(1 month post intervention)
Primary outcome [3] 336508 0
Functional lower extremity strength
Timepoint [3] 336508 0
Baseline(before the treatment begin), 4 weeks(during the treatment), 8 weeks(at the completion of treatment), 12 weeks(1 month post intervention)
Secondary outcome [1] 428611 0
Balance
Timepoint [1] 428611 0
Baseline(before the treatment begin), 4 weeks(during the treatment), 8 weeks(at the completion of treatment), 12 weeks(1 month post intervention)
Secondary outcome [2] 428612 0
Quality of Life
Timepoint [2] 428612 0
Baseline(before the treatment begin), 12 weeks(1 month post intervention)

Eligibility
Key inclusion criteria
i. Patients with subacute (7 days to 6 months post-stroke) and chronic stroke(more than 6 months) diagnosed clinically by a medical doctor in the last 2 years.
ii. Aged 40 – 75 years old
iii. Able to ambulate 10m with or without aid (Functional Ambulation Category(FAC) 3 and above)
iv. Modified Ashworth Scale of the lower limb of 2 and below(marked increase in muscle tone but limb easily flexed)
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Montreal Cognitive Assessment Scale of 24 or lower.
ii. Health issue that met criteria of exclusion (e.g. dementia, aphasia)
iii. Relevant neurological conditions affecting function, especially Parkinson/movement disorder or vestibular disorder
iv. Musculoskeletal conditions that affect the ability to STS like severe OA, fall, and fracture within the past 6 months)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
Statistical software Statistical Package for the Social Sciences (SPSS) version 25.0 will be used for data analysis. Descriptive analysis will be done to analyze socio-demographic data and will be reported as frequency, mean (standard deviation), or median (interquartile range). A mixed model Analysis of Covariance (ANOVA) will be used to analyze the intervention effects within time points, within groups, and between groups. A value of P < 0.05 is considered statistically significant. The data collected will be analyzed using an intention-to-treat basis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 25954 0
Malaysia
State/province [1] 25954 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 315165 0
Hospital
Name [1] 315165 0
HOSPITAL REHABILITASI CHERAS
Country [1] 315165 0
Malaysia
Primary sponsor type
Individual
Name
ASSOC PROF DR.NOR AZLIN BINTI MOHD NORDIN
Address
UNIVERSITI KEBANGSAAN MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 317699 0
None
Name [1] 317699 0
Address [1] 317699 0
Country [1] 317699 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314099 0
NATIONAL MEDICAL RESEARCH REGISTRY
Ethics committee address [1] 314099 0
Ethics committee country [1] 314099 0
Malaysia
Date submitted for ethics approval [1] 314099 0
19/10/2023
Approval date [1] 314099 0
Ethics approval number [1] 314099 0

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

Contacts
Principal investigator
Name 130406 0
Mrs NANCY ANNE JOSOP
Address 130406 0
Icare Rehab, Health Science Faculty,National University of Malaysia,Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 130406 0
Malaysia
Phone 130406 0
+60193594418
Fax 130406 0
Email 130406 0
[email protected]
Contact person for public queries
Name 130407 0
NANCY ANNE JOSOP
Address 130407 0
Icare Rehab, Health Science Faculty,National University of Malaysia,Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 130407 0
Malaysia
Phone 130407 0
+6039289 7000
Fax 130407 0
Email 130407 0
[email protected]
Contact person for scientific queries
Name 130408 0
NANCY ANNE JOSOP
Address 130408 0
Icare Rehab, Health Science Faculty,National University of Malaysia,Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 130408 0
Malaysia
Phone 130408 0
+6039289 7000
Fax 130408 0
Email 130408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.