Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001664134
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
28/11/2019
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Autogenic Relaxation Training in Addition to Usual Physiotherapy on Emotional State and Functional Independence of Stroke Survivors
Scientific title
Effectiveness of Autogenic Relaxation Training in Addition to Usual Physiotherapy on Emotional State and Functional Independence of Stroke Survivors
Secondary ID [1] 299384 0
NN-2018-164
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 314556 0
Anxiety 315337 0
Condition category
Condition code
Stroke 312895 312895 0 0
Haemorrhagic
Mental Health 312896 312896 0 0
Anxiety
Stroke 313391 313391 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall intervention was carried out in the form of a one-to-one session for each participant. Each session consisted of 20 minutes of Autogenic Relaxation Therapy (ART) followed by 40 minutes of usual physiotherapy. ART is a type of “psychophysiological self-control therapy which has certain combinations of psychophysiologically adapted stimuli that refers to the individual concentrates in the inner sensations such as the heaviness and warmth of limbs, heartbeat, breathing, abdominal warmth and the cooling of the forehead. The one-to-one sessions ran weekly with a total of 12 weeks. All participants were required to carry out the ART and a set of home exercise programs such as balance exercises and limb training are prescribed by physiotherapists for two times per week during the 12week intervention. The duration and frequency of exercise or physical activity were most frequently recorded in the diary.
Intervention code [1] 315643 0
Rehabilitation
Intervention code [2] 315973 0
Treatment: Other
Intervention code [3] 315974 0
Behaviour
Comparator / control treatment
The subjects will be assigned to either an experimental group (ART-added physiotherapy)
or a control group using a block randomization method.
The control group will receive usual physiotherapy alone for 1 hour. Usual neurological
physiotherapy interventions received by both groups focus on the functional activity-
training including balance, gait, upper limb and lower limb training.
Control group
Active

Outcomes
Primary outcome [1] 321496 0
The hospital anxiety and depression scale (HADS) is a self-reported questionnaire and most reliable instrument to identify the presence of depression and anxiety
Timepoint [1] 321496 0
All the participants will be assessed before and after the standardized treatment to identify the level of anxiety and depression.
Primary outcome [2] 321497 0
Recovery Locus of control.
The ability of the recovery locus of control scale (RLOC) is to predict physical functioning among stroke patients.
Timepoint [2] 321497 0
Recovery Locus of control is administered before and after the standardized treatment for predicting physical functioning among stroke patients
Primary outcome [3] 321875 0
Barthel index (BI) is a tool to measure the degree of assistance needed by a person, using 10 specific activities of daily living.
Timepoint [3] 321875 0
All the participants will be assessed before and after the standardized treatment to identify the level of physical disability
Secondary outcome [1] 375137 0
The 5-level EQ-5D version (EQ-5D-5L).EQ5D5L is a standardized instrument for measuring generic health status.
Timepoint [1] 375137 0
This will be administered before and after the commencement of treatment.

Eligibility
Key inclusion criteria
the Inclusion criteria are
First-time stroke- diagnosed by Medical Physician
Acute and subacute phase (2 weeks-3 months) with medically stable condition
Age 30 to 75 years
and The Montreal Cognitive Assessment (MoCA) score should be 26 or above
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of any psychosomatic disorders

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed-mode ANOVA

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/12/2018
Date of last participant enrolment
Anticipated
19/08/2020
Actual
Date of last data collection
Anticipated
19/12/2020
Actual
Sample size
Target
80
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 21882 0
Malaysia
State/province [1] 21882 0
Selangor

Funding & Sponsors
Funding source category [1] 303897 0
University
Name [1] 303897 0
The National University of Malaysia
Country [1] 303897 0
Malaysia
Primary sponsor type
Individual
Name
Deepak Thazhakkattu Vasu
Address
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 304045 0
Individual
Name [1] 304045 0
Dr. Nor Azlin Mohd Nordin
Address [1] 304045 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country [1] 304045 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304403 0
Research & Innovation,Faculty of Health Sciences
Ethics committee address [1] 304403 0
PROF. DR. SITI BALKIS BUDIN
Deputy Dean (Research & Innovation)
Fakulti Sains KesihatanFaculty of Health Sciences, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur Malaysia
Ethics committee country [1] 304403 0
Malaysia
Date submitted for ethics approval [1] 304403 0
23/07/2018
Approval date [1] 304403 0
25/10/2018
Ethics approval number [1] 304403 0
NN-2018-164

Summary
Brief summary
The stroke survivors have serious emotional interruption; the most common being anxiety and depression, which are normally characterized by low motivation, have a negative influence on the recovery of functions following stroke. This study is proposed to evaluate the effectiveness of Autogenic relaxation therapy in addition to usual physiotherapy in improving the emotional state and functional level of stroke survivors during the early phase of rehabilitation. The expected main study outcome is an enhanced evidence-based physiotherapy program that may be used by physiotherapists in the rehabilitation of stroke patients with anxiety and depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96826 0
Mr Deepak Thazhakkattu Vasu
Address 96826 0
Faculty of Health Sciences, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur Malaysia
Country 96826 0
Malaysia
Phone 96826 0
+60146426436
Fax 96826 0
Email 96826 0
[email protected]
Contact person for public queries
Name 96827 0
Mr Deepak Thazhakkattu Vasu
Address 96827 0
Faculty of Health Sciences, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur Malaysia
Country 96827 0
Malaysia
Phone 96827 0
+60146426436
Fax 96827 0
Email 96827 0
[email protected]
Contact person for scientific queries
Name 96828 0
Mr Deepak Thazhakkattu Vasu
Address 96828 0
Faculty of Health Sciences, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur Malaysia
Country 96828 0
Malaysia
Phone 96828 0
+60146426436
Fax 96828 0
Email 96828 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?
The functional quality of life (EQ5D5L) and HADS for anxiety will be shared.
When will data be available (start and end dates)?
Available for 5 years after publication
Available to whom?
Available through peer review / scientific journal
Available for what types of analyses?
Any purposes
How or where can data be obtained?
Access subject to approvals by Principal Investigator, by emailing the principal investigator
[email protected], [email protected]


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.