Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000945628
Ethics application status
Approved
Date submitted
11/08/2014
Date registered
4/09/2014
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Customized Vestibular Rehabilitation (CVR) on balance in adults with Benign Paroxysmal Positional Vertigo
Scientific title
Effects of Customized Vestibular Rehabilitation / CVR on balance in adults with idiopathic unilateral posterior canal benign paroxysmal positional vertigo (IUPC BPPV)
Secondary ID [1] 285137 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic unilateral posterior canal benign paroxysmal positional vertigo 292711 0
functional mobility impairement 292712 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293018 293018 0 0
Physiotherapy
Ear 293079 293079 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: one intervention group who will receive both customized vestibular rehabilitation (CVR) +canalith repositioning maneuver (CRM) .
Once per week for one hour ,
One treatment per week over 6 weeks. (30 min CVR followed by 30 min CRM)
.A trained physiotherapist will administer the sessions.
Arm 2: one control group who will receive only canalith repositioning maneuver (CRM).
Once per week for half an hour
One treatment per week over two weeks
.A trained physiotherapist will administer the sessions.


canalith repositioning maneuver (CRM).Treatment:
The therapist moves the patient through a series of head position change.
I. Place subject into positive dix-hallpike position. Supporting subject’s neck, head rotation 45 degree and quickly assist subject into supine and head hanging position with head extension 20 degree.
II. Without lifting the subject’s head, turn the subject’s head to the opposite dix-hallpike position.
III Supporting subject’s head , asked subjects to turn body until subject is lying on side and nose is pointing to the floor.
IV. Maintaining head position from procedure iii, assist subject to a seated position.
V. Centered subject’s head and asked subject to tilt head down 20 degree.

Customized vestibular rehabilitation (CVR) TREATMENT:
CVR involves performing the vestibular exercises.
Adaptation exercises includes vestibular ocular reflex X1(VOR X1) and vestibular ocular reflex X2 (VOR X2) viewing exercises as described by Herdman (1998) and Shumway cook, & Horak (1990)
Substitution are to Synthesize the use of all sensory input from visual, vestibular and somatosensory system .Subject were taught to substitute vision and somatosensory for the deficit of the vestibular system.
Balance exercises:
Using alternative strategies and sensory information to compensate for the defective vestibular input (Shumway-cook 1997; Horak 1986). Balance exercises were designed to integrade variety of sensory environment such as vision, vestibular and somatosensory input to improve co-ordination of muscles responses and postural balance.. Such exercises includes for example, changing from sitting to standing, turning around or reaching for an object.
Gait exercises:
The exercise were designed to improve functional activiites or dynamic balance related to vestibular function.eg. The subjects begin walking and suddenly stopped at physiotherapist command. The progression to increase task difficulty were to increase walking speed or alter walking speed at physiotherapist command before stopping.

To ensure adherence to the intervention, a call rem.
inder for attendance will be made once a week before the next appointment.
Intervention code [1] 289989 0
Rehabilitation
Intervention code [2] 290046 0
Treatment: Other
Comparator / control treatment
Intervention group: CVR in addition to CRM
Control group: CRM
Control group
Active

Outcomes
Primary outcome [1] 292878 0
primary outcome 1. Assessment of balance and functional mobility of BPPV patients will be performed using the mobility lab (APDM). Functional or system clinical balance assessment (iTUG & iCTSIB) .will be instrumented using wearable inertial sensor.
Timepoint [1] 292878 0
at baseline and at 4, 6 weeks after intervention commencement
Secondary outcome [1] 309867 0
1. Measures of confidence level on balance using activities balance confidence /ABC scale.
Timepoint [1] 309867 0
at baseline and at 4,6 weeks after intervention commencement
Secondary outcome [2] 309988 0
2. Measures of perceived level of handicap on dizziness using dizziness handicap inventory scale
/ DHI
Timepoint [2] 309988 0
baseline, 4 weeks and 6 weeks

Eligibility
Key inclusion criteria
i. a diagnosis of IUPC BPPV.
ii. age between 30-65
iii. independent mobility(walking with no more support than a single walking stick
iv. no other major neurological history (stroke) or Orthopaedic problem that impacts on functional mobility.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Bilateral BPPV, Horizontal or anterior canal BPPV
II. Have had previous vestibular rehabilitation
iii. CNS / central nervous system involvement
iv. secondary BPPV due to head trauma, meniere's disease, labrynthitis
v. unstable medical condition ( eg. severe hypertension and unstable heart problem) and other orthopaedic and neurological condition that may affect the postural balance.

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 to intervention will be concealed in a sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization will be employed to minimize observation bias and to prevent time related influences from disturbing the homogeneity of between groups over the data collection period.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed ANOVA will be used to estimate the main effects of within group on postural sway and functional mobility ( at baseline, 4 weeks and 6 weeks) and intervention effect will be calculated between group ( intervention group and control group). Power analysis was calculated based on the G power 3.0 (ANOVA).power analysis shows that this sample size should be sufficient to review any significant differences between two different groups of participants. ( effect size = 0.4, power = 0.80, p < 0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2014
Actual
15/10/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
31/03/2015
Date of last data collection
Anticipated
Actual
31/03/2015
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 6287 0
Malaysia
State/province [1] 6287 0
selangor

Funding & Sponsors
Funding source category [1] 289794 0
Self funded/Unfunded
Name [1] 289794 0
Country [1] 289794 0
Primary sponsor type
Individual
Name
Dr Devinder Kaur
Address
Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 288485 0
None
Name [1] 288485 0
Address [1] 288485 0
Country [1] 288485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291479 0
UKM Research Ethics Committee
Ethics committee address [1] 291479 0
Medical research & innovation secretariat 1st floor, clinical block, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia.
Ethics committee country [1] 291479 0
Malaysia
Date submitted for ethics approval [1] 291479 0
Approval date [1] 291479 0
25/05/2014
Ethics approval number [1] 291479 0

Summary
Brief summary
The purpose of the study is to evaluate the effectiveness of CVR in addition to CRM on balance among adults with IUPC BPPV.
Study Hypothesis : i. There will be a significant effects of CVR in addition to CRM on static & dynamic balance among adults with IUPC BPPV at 4 weeks and 6 weeks follow up.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 156 156 0 0
/AnzctrAttachments/366881-ethic approval 3 UKM 25.5.14.docx
Attachments [2] 157 157 0 0
/AnzctrAttachments/366881-ethic approval 4 UKM 25.5.14.docx

Contacts
Principal investigator
Name 50582 0
Dr Dr Devinder Kaur Ajit Singh
Address 50582 0
Physiotherapy program, School of Rehabilitation Sciences, Faculty of Health Science, The National University of Malaysia.Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.
Country 50582 0
Malaysia
Phone 50582 0
+603 2687 8003
Fax 50582 0
+603 2687 8199
Email 50582 0
devinderkas@gmail.com
Contact person for public queries
Name 50583 0
Dr Devinder Kaur Ajit Singh
Address 50583 0
Physiotherapy program, School of Rehabilitation Sciences, Faculty of Health Science, The National University of Malaysia.Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.
Country 50583 0
Malaysia
Phone 50583 0
+603 2687 8003
Fax 50583 0
+603 2687 8199
Email 50583 0
devinderkas@gmail.com
Contact person for scientific queries
Name 50584 0
Dr Devinder Kaur Ajit Singh
Address 50584 0
Physiotherapy program, School of Rehabilitation Sciences, Faculty of Health Science, The National University of Malaysia.Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia.
Country 50584 0
Malaysia
Phone 50584 0
+603 2687 8003
Fax 50584 0
+603 2687 8199
Email 50584 0
devinderkas@gmail.com

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