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临床试验/NCT05103748
NCT05103748Unknown不适用

Function Evaluation of Older Patients With Vertigo and Intervention Study of New Rehabilitation Methods

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
226
试验地点
1
主要终点
Dizziness handicap inventory scale

研究概览

简要总结

By evaluating the balance, gait and cognitive functions of the elderly patients with vertigo, the relevant functional disorders of the elderly patients with vertigo were clarified, and the functional disorders of the elderly patients with vertigo were improved through the new rehabilitation intervention.

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
None

入排标准

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

入选标准

  • Older than 60 years old
  • It meets the diagnostic criteria of vertigo disease
  • Agree to participate in the experiment

排除标准

  • Complete paralysis caused by severe cerebrovascular diseases
  • Patients with disability and dementia and long-term bedridden
  • Unwilling to cooperate with the visitors
  • Patients who did not meet the inclusion criteria

结局指标

主要结局

Dizziness handicap inventory scale

时间窗: 8 weeks

The dizziness handicap inventory consists of 25 items divided into 3 domains believed to encompass the impact of the disease: functional (9 questions), emotional (9 questions), and physical (7 questions). Each item is assigned 0, 2, or 4 points; therefore, the dizziness handicap inventory total scores is between 0 and 100 points. Mild dizziness(dizziness handicap inventory scale score ≤30) and moderate to severe dizziness(dizziness handicap inventory scale score \>30).

Morse Fall scale

时间窗: 8 weeks

There are six main variables measured by the Morse Fall scale: (1) history of falling (possible score of 0 or 25); (2) secondary diagnosis (0 or 15); (3) ambulatory aid (0, 15, or 30); (4) IV or IV access (0 or 20); (5) gait (0, 10, 20); and (6) mental status (0 or 15). The total score can range from 0-125. The scale developers recommend a cut-off point of 45; though, calibration of the scores for patient symptoms and healthcare setting is advised. In this study setting, Morse Fall scale scores of 0-24 were classified as no risk, 25-50 as low risk and 51-125 as high risk.

Short physical performance battery scale

时间窗: 8 weeks

Each of the three subtests (balance, walking speed and repeated chair sit-to-stand test) of the short physical performance battery scale was scored from 0 to 4. The minimum test score is 0 point and maximum test score is 12 points. Higher scores indicate better physical performance.

Dynamic Gait Index scale

时间窗: 8 weeks

Dynamic Gait Index scale consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over obstacle, gait around obstacles and steps up and down stairs. The performance on each item is rated on a 4-point scale (3, independent walking; 2, mild impairment; 1, moderate impairment; 0, severe disorder). The minimum test score is 0 point and maximum test score is 24 points. Higher scores indicate better gait performance.

Frail scale

时间窗: 8 weeks

Frailty was assessed using the frail scale. There are 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. The presence of each characteristic was scored with 1 point and the absence of each characteristic was scored with 0 point. The frail score ranges from 0 to 5, where a score of 0 represents robust, 1-2 as pre-frail, and 3-5 as frail.

Berg balance scale

时间窗: 8 weeks

The berg balance scaleis composed of 14 items that assess an individual's performance on specific functional tasks. Each item is scored from 0 to 4. The minimum test score is 0 point and maximum test score is 56 points. Higher scores indicate better balance performance.

Montreal Cognitive Assessment Scale

时间窗: 8 weeks

The Montreal Cognitive Assessment Scale includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; \< 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.

Visual analogue scale

时间窗: 8 weeks

The visual analogue scale for dizziness used a straight line of 10 cm in length. The numbers between 0 and 10 were marked at equal intervals along the line. The participants were asked to report their self-perceived dizziness on a visual analogue scale describing the severity of dizziness in everyday life on a continuum from 0 (none dizziness) to 10 (extremely severe dizziness).

Generalized Anxiexy Disorde-7 scale

时间窗: 8 weeks

The presence of perceived anxiety was evaluated with the Generalized Anxiety Disorder 7-item scale. A score of≤9 points indicates no or mild anxiety; \>9, moderate to severe anxiety.

Mini-mental State Examination

时间窗: 8 weeks

Mini-mental State Examination includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;\< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and \< 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.

次要结局

  • Dataset of functional magnetic resonance imaging on brain(8 weeks)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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