跳至主要内容
临床试验/NCT06625281
NCT06625281招募中不适用

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

Foundation University Islamabad2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Dizziness

研究概览

简要总结

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.

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..

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The participants will be kept unaware of which group they will be allocated and type of the intervention they will receive, whereas the investigator will be aware regarding the allocation and type of the intervention given to the participants. Single blinding is used in this study.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Dizziness

时间窗: 6 weeks

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.

Quality of Life

时间窗: 6 weeks

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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