Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000727842
Ethics application status
Approved
Date submitted
27/11/2020
Date registered
10/06/2021
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of carer-mediated game-based circuit exercise on functions and quality of life among stroke survivors: A protocol for randomized controlled trial
Scientific title
Effectiveness of carer-mediated game-based circuit exercise on functions and quality of life among stroke survivors: A protocol for randomized controlled trial
Secondary ID [1] 302890 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stroke 319893 0
Condition category
Condition code
Stroke 317826 317826 0 0
Haemorrhagic
Stroke 317827 317827 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The game-based circuit exercise perform in the experimental group will be in form of video link web/internet supported which is consisted of; a) resistance exercises including sit to stand, partial squat, step up down, hip raise and heel raise, b) balance exercises including figure of eight walking, tandem walking, backward walking, walking with instruction and walking with sudden change direction and c) aerobic exercises including punching jab, hook, cross straight and combination punching manuovers and squat/kicking. Exercise adherence and performance will be monitored using website analytic in a form of automatic reported activity diary and Borg Scale Rate of Perceived Exertion, respectively. A carer will supervise the participants performing this therapy on a one-to-one basis at their home (A carer will undergone 1 hour web/internet supported game-based circuit exercise hands on training session with researcher at the physiotherapy clinic earlier). All participants in this group will receive 24 x 1 hour sessions, twice/week for 12 weeks. This game-based circuit exercise program was designed specifically for this study.
Intervention code [1] 319174 0
Treatment: Other
Intervention code [2] 319175 0
Rehabilitation
Comparator / control treatment
The control group will continue game-based circuit exercise led by physiotherapist with minimum 5 years' experience at the physiotherapy clinic. All participants in this group will receive 24 x 1 hour sessions, twice/week for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 325846 0
Lower limb strength assessed using the 30-second Chair Rise test
Timepoint [1] 325846 0
Baseline and at 12 weeks after intervention commencement
Primary outcome [2] 325847 0
Postural stability assessed using the Dynamic Gait Index

Timepoint [2] 325847 0
Baseline and at 12 weeks after intervention commencement
Primary outcome [3] 325848 0
Aerobic endurance assessed using the S6-Minute Walk test

Timepoint [3] 325848 0
Baseline and at 12 weeks after intervention commencement
Secondary outcome [1] 389341 0
Quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [1] 389341 0
Baseline and at 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Participants who are; 1) diagnosed at least 2 months after stroke either hemorhagic or ischemic by a Neurology physician, 2) able to walk continuously for 10 meters independently with or without walking aid, 3) able to perform basic instrumental activities of daily living such as walking, stepping up and turning with or without walking aid, 4) able to hold a glass full of water with the non-affected hand and 5) able to follow 3 steps command and 6) physically healthy without disability based on Nagi’s concepts (Pope & Tarlov 1991) will be recruited in this trial.
Minimum age
55 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants had, 1) more than one stroke, 2) other neurologic disorders such as Parkinson’s Disease and traumatic brain injury, 3) an average Montreal Cognitive Assessment score of 22.1 and less, 4) severe orthopedic conditions such as joint deformities, osteoarthritis and rheumatoid, 5) visual field defects or 6) currently on medications which can caused giddiness such as anti-hypertensive (alpha-blockers) and medicine to lower hypercholesterol (amlodipine/atorvastatin) will be excluded.

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)
Allocation will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization will be used. This study is also using stratified randomization as group randomization method. Two confounding factors have been considered for stratification which are co-morbidities (presence or absence) and stroke subtype (ischemic or hemorrhagic).
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
The sample size has been determined by G*Power 3.1.9.7 software using F tests with ANOVA: Repeated measures, between group.

A Mixed Model ANOVA will be used to evaluate the effectiveness of 12-week game-based circuit exercises carer-mediated, in-home in improving lower limb strength, postural stability, aerobic endurance and quality of life in stroke survivor as compared to therapist-led, in-hospital.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2021
Actual
Date of last participant enrolment
Anticipated
31/01/2023
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment outside Australia
Country [1] 23230 0
Malaysia
State/province [1] 23230 0
WILAYAH PERSEKUTUAN KUALA LUMPUR

Funding & Sponsors
Funding source category [1] 307313 0
Self funded/Unfunded
Name [1] 307313 0
Investigator own fund
Country [1] 307313 0
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz,
Universiti Kebangsaan Malaysia,
50300 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 307948 0
Hospital
Name [1] 307948 0
Hospital Raja Perempuan Zainab II
Address [1] 307948 0
Medical Department, Hospital Raja Perempuan Zainab II,
15586 Kota Bharu, Kelantan
Country [1] 307948 0
Malaysia
Secondary sponsor category [2] 307949 0
Hospital
Name [2] 307949 0
Hospital Sultanah Aminah Johor Bharu Johor
Address [2] 307949 0
Hospital Sultanah Aminah, Jalan, Persiaran Abu Bakar Sultan, 80000 Johor Bahru, Johor
Country [2] 307949 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307404 0
National Medical Research Review, Ministry of Health
Ethics committee address [1] 307404 0
Ethics committee country [1] 307404 0
Malaysia
Date submitted for ethics approval [1] 307404 0
03/01/2020
Approval date [1] 307404 0
04/06/2020
Ethics approval number [1] 307404 0
NMRR-19-2961-51209-IIR

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

Contacts
Principal investigator
Name 107114 0
Mr Mohd Naqiuddin Johar
Address 107114 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz,
Universiti Kebangsaan Malaysia,
50300 Kuala Lumpur, Malaysia
Country 107114 0
Malaysia
Phone 107114 0
+60326914304
Fax 107114 0
+60392897522
Email 107114 0
[email protected]
Contact person for public queries
Name 107115 0
Mohd Naqiuddin Johar
Address 107115 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz,
Universiti Kebangsaan Malaysia,
50300 Kuala Lumpur, Malaysia
Country 107115 0
Malaysia
Phone 107115 0
+60326914304
Fax 107115 0
+60392897522
Email 107115 0
[email protected]
Contact person for scientific queries
Name 107116 0
Mohd Naqiuddin Johar
Address 107116 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz,
Universiti Kebangsaan Malaysia,
50300 Kuala Lumpur, Malaysia
Country 107116 0
Malaysia
Phone 107116 0
+60326914304
Fax 107116 0
+60392897522
Email 107116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data of published results only
When will data be available (start and end dates)?
1/5/2023 until 31/8/2023
Available to whom?
Any researcher
Available for what types of analyses?
Statistical analysis
How or where can data be obtained?
Contact the investigator through [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9886Ethical approval    381014-(Uploaded-01-06-2021-21-41-42)-Study-related document.pdf



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.