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DizzinessNCT06625281

Effects of Epleys Maneuver Versus Semont-Plus Maneuver Combined with Brandt-Daroff Exercises on Dizziness and Quality of Life in Benign Paroxysmal Positional Vertigo

A study testing Epleys Maneuver, Semont-plus maneuver and Brandt-Daroff exercises in people with Dizziness and Benign Paroxysmal Positional Vertigo (BPPV), run by Foundation University Islamabad at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Vestibular hypofunction can result in symptoms consisting of dizziness, imbalance, and/or oscillopsia, gaze and gait instability, and impaired navigation and spatial orientation; thus, may negatively impact an individual\'s quality of life, and ability to perform activities of daily living. Read more about this study

Who is it for?
Ages 20 to 65 years
What is being tested?
Epleys Maneuver, Semont-plus maneuver and Brandt-Daroff exercises
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
20 Jul 2024to 20 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both genders
  • Positive Dix Hallpike test.
  • Patients diagnosed with Posterior canal Benign Paroxysmal Positional Vertigo.
  • Patients with recurrent episodes of dizziness.
  • Age group 20-65.
  • Positive Dix Hallpike Test

Who cannot join

  • Dix Hallpike test negative.
  • DHI Scale: 54+ Severe
  • Trauma
  • Ankylosing spondylitis
  • Cervical pathology-related dizziness
  • Spinal cord injury
  • Carotid stenosis
  • Other Vestibular pathologies (Meniere's disease, Vestibular hypofunction, Labyrinthitis

Trial locations and contacts

1 site in 1 country.

MARWA JAVED, DPT contact

+923209502800

marwaa.javed@gmail.com

Pakistan1 site, 1 recruiting
  • Foundation University College of Physical Thrapy

    Islamabad, 44000

    Nida Mushtaq Kayani, MS-NMPT, +923330418548, nida.mushtaq@fui.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Epleys Maneuver Versus Semont-Plus Maneuver Combined with Brandt-Daroff Exercises on Dizziness and Quality of Life in Benign Paroxysmal Positional Vertigo;

Vestibular hypofunction can result in symptoms consisting of dizziness, imbalance, and/or oscillopsia, gaze and gait instability, and impaired navigation and spatial orientation; thus, may negatively impact an individual\'s quality of life, and ability to perform activities of daily living.

Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder which occurs with changing of the positions lying down, rolling over, climbing stairs, or looking up and down. The typical symptoms include dizziness, loss of balance, nystagmus, and nausea, limiting the daily activities of life and functional capacity.

Read more

Much research has been done to rule out the prime treatment for posterior canal-BPPV using vestibular rehabilitation therapy (VRT), Canalith repositioning maneuvers (CRM), and habituation exercises, but scarce literature renders the combination of maneuvers and exercises.

The current study will be used to determine and compare the effects of Epley\'s maneuver Versus the Semont-Plus maneuver combined with Brandt-Daroff exercises on Dizziness and Quality of life in participants with pc-Benign paroxysmal positional vertigo. The participants having clinically diagnosed Posterior canal Benign paroxysmal positional vertigo (BPPV) will be selected in this study.

The outcome measure will be the Dizziness Handicap Inventory (DHI) to assess the Dizziness in participants and Vestibular activities and the participation measure (VAP) will assess the Quality of life. For such a randomized control trial a sample of 40 participants will be taken with 20 participants in each group will be included in the study. One group will undergo Epley's Maneuver and Brandt-daroff exercises and the second group will receive Semont-plus maneuver and Brandt-daroff exercises. Scores will be taken again after intervention. The study will be conducted over 1 year at Fauji Foundation Hospital and Foundation University Islamabad. Participants of interest would be approached and explained about the research. Informed written consent will be taken first. Recruited participants will be allocated to either of the groups through a convenient sampling method.

All outcome measurements would be performed first at baseline and then after the 6 weeks intervention period..

Read the detailed description

OBJECTIVES:

The objectives of this study are:

  1. To determine the Effects of Semont-Plus Maneuver combined with Brandt-Daroff exercises on Dizziness and Quality of life in patients with pc-Benign paroxysmal positional vertigo (BPPV) 2-To determine the Effects of Epley's Maneuver combined with Brandt-Daroff exercises on dizziness and Quality of life in patients with pc-Benign paroxysmal positional vertigo (BPPV) 3-To compare the effects of Epley\'s maneuver combined with Brandt-daroff exercises with the effects of Semont plus maneuver combined with Brandt-daroff exercises on Dizziness and Quality of life in patients with pc-Benign paroxysmal positional vertigo (BPPV)

HYPOTHESIS:

Alternate Hypothesis:

There will be a significant effect in the study group in terms of Dizziness and Quality of life between Epley's maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV (p\<0.05).

Null Hypothesis:

  1. There will be no significant effect in the study groups in terms of Dizziness and Quality of life between Epley's maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV (p\>0.05).

Research Design: Experimental study. Randomized Control Trial

Clinical setting: ENT Department, Fauji Foundation Hospital and Treatment room FUCP.

Study duration: 6 months

Selection Criteria:

Inclusion Criteria

  1. Both genders
  2. Positive Dix Hallpike test.
  3. Patients diagnosed with Posterior canal Benign Paroxysmal Positional Vertigo.
  4. Patients with recurrent episodes of dizziness.
  5. Age group 20-65.
  6. Positive Dix Hallpike Test

Exclusion Criteria

  1. Dix Hallpike test negative.
  2. DHI Scale: 54+ Severe
  3. Trauma
  4. Ankylosing spondylitis
  5. Cervical pathology-related dizziness
  6. Spinal cord injury
  7. Carotid stenosis
  8. Other Vestibular pathologies (Meniere's disease, Vestibular hypofunction, Labyrinthitis

Sampling technique: Convenience Sampling

Outcome Measures:

Data will be collected on Demographics and general information. Dizziness will be assessed through the Dizziness Handicap Inventory (DHI) and Quality of life will be recorded with a Vestibular assessment and participation measure (VAP).

Experimental Group (A) = This group will receive Semont-Plus Maneuver combined with Brandt-daroff exercises interferential therapy and strengthening exercises and their outcomes will be measured at baseline and at the end of 6 weeks of treatment.

Control group (B) =This group will undergo Epley\'s maneuver combined with Brandt-daroff exercises their outcomes will be observed at the baseline and then after treatment of 06 weeks.

Data analysis techniques:

The data will be analyzed through SPSS 21 and Data will be analyzed based on the study design chosen which is a random control experimental study within the community.

A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.

Significance of the study:

  1. Semont-Plus maneuver is a modified form of the Semont maneuver which has been more effective for posterior canal-related vertigo. It is important to find more evidence regarding the Semont-plus maneuver and Brandt-daroff habituation exercises. The combination of this maneuver with Brandt-Daroff exercises will have a remarkable effect on dizziness and thus improve the quality of life of the patients.
  2. This study will provide valuable data regarding the comparison of Epley's Maneuver and Semont Maneuver along with their combination with Brandt-daroff exercises.
  3. This study will provide awareness and valuable literature regarding the comparison and combination of maneuvers and exercises. Scarce literature is present regarding the combination of vestibular maneuvers and exercises.
  4. An awareness for the health care community to use a new technique of combination. The maneuvers and exercises are quick to perform and can be a part of clinical and emergency conditions.
Being tested
Epleys Maneuver, Semont-plus maneuver, Brandt-Daroff exercises
Keywords
PhysicalTherapy, Vestibular Rehabilitation Therapy, Benign Paroxysmal Positional Vertigo
Medical subject headings
Dizziness, Benign Paroxysmal Positional Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epleys ManeuverProcedure or surgery

    • The patient begins in an upright sitting posture, with the legs fully extended and the head rotated 45 degrees towards the affected side.
    • The patient is then quickly and passively forced down backwards by the therapist performing the treatment into a supine position with the head held approximately in a 30-degree neck extension
    • The therapist observes the patient's eyes for "primary stage" nystagmus. The patient remains in this position for 1-2 minutes.
    • The patient's head is then turned 90 degrees to the opposite direction so that the unaffected ear faces the ground, for 1-2 minutes.
    • Keeping the head and neck in a fixed position relative to the body, the individual rolls onto their shoulder, rotating the head another 90 degrees in the direction they are facing. The patient is now looking downwards at a 45-degree angle.
    • The eyes should be immediately observed by the therapist for "secondary stage" nystagmus. The patient remains in this position for 1-2 minutes.
  • Semont-plus maneuverProcedure or surgery

    • The Semont-plus maneuver includes the upright position with turning of the head by 45° toward the non-affected side.
    • Then movement of the body by 150° toward the affected side, which moves the otoconia further in the direction in which they should move and since the clot is beyond the vertex, the movement of body by 240° moves the clot into the direction of the vestibulum.
  • Brandt-Daroff exercisesProcedure or surgery

    • Patient sits on the edge of bed. and lies down onto the side that causes dizziness to increase. Look towards the ceiling. Stay in this position for 2 minutes.
    • Sits upright and then wait for 30 seconds.
    • Moves rapidly to the opposite side for 2 minutes.
Study groups in NCT06625281
Study groupRoleWhat they receive
Interventional Group AActive comparatorIt includes participants receiving Epley's Maneuver combined with Brandt-daroff exercises for 6 weeks of treatment.
Receives: Procedure: Epleys Maneuver; Procedure: Brandt-Daroff exercises
Interventional Group BExperimentalThis group involves participants receiving Semont-Plus Maneuver along with Brandt-daroff exercises for a period of 6 weeks.
Receives: Procedure: Semont-plus maneuver; Procedure: Brandt-Daroff exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dizziness

    Dizziness Handicap Inventory scale (DHI) is used to assess Dizziness and can be used therapeutically to monitor and adjust rehabilitation therapy.The DHI is a 25-item self-reported measure with three categories: functional, emotional, and physical.

    Measured: 6 weeks

  2. Quality of Life

    Change in the health related quality of life using Vestibular activities and participation measure (VAP) assesses the effect of dizziness on quality of life and activities of daily living.VAP is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start20 Jul 2024
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion20 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625281
Sponsor's protocol ID
FUI/CTR/2024/30
Status last verified
Sep 2024
First submitted
1 Oct 2024
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Epleys Maneuver, Semont-plus maneuver and Brandt-Daroff exercises in people with Dizziness and Benign Paroxysmal Positional Vertigo (BPPV), run by Foundation University Islamabad at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MARWA JAVED, DPT (+923209502800, marwaa.javed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dizziness (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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