To compare the effects of Semont and Epley’s maneuver in patients with Benign Paroxysmal Positional Vertigo (BPPV) using Patient Specific functional scale and Activity based Confidence (ABC) scale
Design
Randomized Control Trial RCT, Single blind study
Study groups: Epley's and Semont group
Phase: N.A
Sample size : 24
Randomization: In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The study is single blinded as participants is not aware of the intervention group they are placed in.
Study center: Single center study
Settings and conduct
Health care unit in Islamabad (ENT department)
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The study is single blinded as participants is not aware of the intervention group they are placed in.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Diagnosed Benign paroxysmal positional vertigo
• Patients with recurrent rotatory vertigo attacks proceeded by rapid and/or gravity-dependent head
movements
• Patients with active daily life activities between ages 20 to 65 years
• Patients having positional dizziness
Exclusion criteria:
• Patients who have any neuromuscular comorbidity
• Patients on any kind of drug or sedative during study
• Patients with epilepsy or on epileptic drugs
• Patient with highly impaired vision
• Bilateral Benign paroxysmal positional vertigo
Intervention groups
There are 2 groups .
1. Epley's Group
2. Semont Group
Main outcome variables
1. Patient specific functional scale to evaluate functional scale
2. Activity based confidence scale to evaluate confidence level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052835N1
Registration date:2021-12-01, 1400/09/10
Registration timing:retrospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Fouzia Batool
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441752
Email address
fouzia_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-05, 1400/01/16
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
2021-04-14, 1400/01/25
Actual recruitment end date
2021-08-08, 1400/05/17
Trial completion date
2021-08-08, 1400/05/17
Scientific title
Comparison of Semont and Epley's maneuver in Patients with benign paroxysmal positional vertigo
Public title
Comparison of Semont and Epley's maneuver in vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed Benign paroxysmal positional vertigo
Patients with active daily life Activities between ages 25 to 65 years
Patients having positional dizziness
Patients with recurrent rotatory vertigo attacks proceeded by rapid and/or gravity-dependent head movements
Exclusion criteria:
Patients who have any neuromuscular comorbidity
Patients on any kind of drug or sedative during study
Patients with epilepsy or on epileptic drugs
Patient with highly impaired vision
Bilateral Benign paroxysmal positional vertigo
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Actual sample size reached:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the patient for their participation in the study, the therapist opens the envelop and give the respective treatments to the patients . The study is single blinded as participants is not aware of the intervention group they are placed in.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are single blinded as they don't know which treatment plan or intervention is given to them.
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board and ethical committee shifa tameer-e-millat and shifa international hospi
Street address
Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad
City
Islamabad
Postal code
44790
Approval date
2021-04-01, 1400/01/12
Ethics committee reference number
IRB#08-21
Health conditions studied
1
Description of health condition studied
Benign paroxysmal positional vertigo is a spinning sensation in head that leads to vertigo and dizziness. it can be treated with rehabilitative techniques and positioning maneuvers.
To compare the effects of Semont and Epley’s maneuver in patients with BPPV using Patient Specific functional scale and Activity based Confidence scale
Timepoint
Single session, before and after treatment
Method of measurement
Patient specific functional scale and Activity based confidence scale
Secondary outcomes
1
Description
To determine the effects of Semont and Epley’s maneuver in patients with BPPV using Patient Specific functional scale and Activity based confidence scale
Timepoint
Single session, before and after treatment
Method of measurement
Patient specific functional scale and Activity based confidence scale
Intervention groups
1
Description
Intervention group1 : Epley's Group is given Epley's maneuver has sequential movement of the head into four positions staying in each position for roughly 30 seconds. It includes supine lying, 45 degree head rotation, head extension , head rotation and then sitting. It is intended to move debris or "ear otoconia" out of the sensitive part of the ear (posterior canal) to a less sensitive location. It is also sometimes called the "canalith repositioning maneuver".
Category
Rehabilitation
2
Description
Intervention group 2: Semont Group is given Semont maneuver in which patient sit on the edge of bed. First patient head is turned 45 degrees to the right and then quickly lie down him on left side. This position is maintained for 30 seconds. And then the patient is quickly move to lie down on the opposite end of the bed. After that return him slowly to sitting and wait a few minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Atomic energy commision (PAEC ) General hospital