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临床试验/NCT05013671
NCT05013671Unknown不适用

Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls

Hasselt University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
360° turn

研究概览

简要总结

BPPV is a benign condition of the balance organ, localized in the inner ear, in which calcium crystals loosen up and move freely in the endolymphatic fluid of the inner ear (more specifically in the semi-circular canals). During certain posture changes or head movements, these moving calcium crystals cause dizziness and balance problems. The general objective of the study is to evaluate the impact of BPPV on the balance of older adults in nursing homes. For this purpose, we will compare the balance of residents with BPPV with residents without BPPV. Furthermore, we will identify the impact of treatment on balance problems and fall risk in older adults in nursing homes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Institutionalized for at least 3 months
  • Willing to participate
  • Able to understand simple instructions
  • Able to stand independently for 10 seconds (with the use of a walking aid)

排除标准

  • Diagnosis of progressive neurological conditions resulting in a fast deterioration (i.e. amyotrophic lateral sclerosis or residents with palliative care)
  • Participation in a rehabilitation program at the current time for a pathology of less than 6 months
  • Contra-indication for vestibular testing such as heart failure or fear

结局指标

主要结局

360° turn

时间窗: month 12

Measuring dynamic balance during a 360° turn

10 meter walk test

时间窗: Month 12

The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.

Dizziness Handicap Inventory

时间窗: Month 12

Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.

Falls Efficacy Scale International

时间窗: Month 12

Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).

Static balance

时间窗: Month 12

Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.

Timed up and Go (TUG)

时间窗: Month 12

Measuring dynamic balance and gait during TUG over a 3 meter distance

The presence of BPPV

时间窗: Month 12

This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.

Knee extensor strength

时间窗: Month 12

The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.

次要结局

  • Sleep pattern (retrospective data retrieved from patient files)(Month 12)
  • Katz-ADL (retrospective data retrieved from patient files)(Month 12)
  • Hospital anxiety and depression scale (HADS)(Month 12)
  • Medication (retrospective data retrieved from patient files)(Month 12)
  • Comorbidities (retrospective data retrieved from patient files)(Month 12)
  • Nutrition (retrospective data retrieved from patient files)(Month 12)
  • Fall incidents(month 12)
  • Montreal Cognitive Assessment (MOCA)(Month 12)
  • Geriatric Depression Scale (GDS)(Month 12)
  • Frailty status(month 12)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

JSpildooren

Principal Investigator

Hasselt University

研究点 (2)

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