Effectiveness of vestibular therapy as an adjunct to cognitive therapy to improve cognition in elderly with mild cognitive impairment (MCI): A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Electroencephalogram to study brain waveforms in terms of spectrum and coherence that correspond to different cognitive functions including attention memory reasoning information processing.
研究概览
简要总结
Background and Aim - Considering the critical input of the vestibular system to the hippocampus as an area involved in cognition, we aim to investigate the effectiveness of vestibular therapy as an adjunct to cognitive therapy to improve cognition in elderly with mild cognitive impairment.
Methodology - It will be a prospective randomized controlled trial, including the elderly (60 years of age and above, both males and females, and have a primary level of education). The participants will be screened for mild cognitive impairment using the Addenbrooke Cognitive Examination – III scale and Mini-mental examination scale. A short-falls efficacy scale will be used to determine a minimum to no risk for falls. 36 patients with mild cognitive impairment will be randomly assigned to three groups receiving 1. Group 1 – Vestibular therapy along with cognitive therapy, 2. Group 2 – cognitive therapy alone, 3. Group 3 – No specific intervention will be given to the patients and they will be asked to continue with their activities of daily living during the study duration.
Results - will be reported for all the outcome measures at baseline, post-intervention at the 8th week from baseline, and at the 10th week from baseline. Statistical analysis using SPSS software for Anova with repeated measures will be done to find within and between the group interactions with post hoc analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Elderly aged 60 years and above Both females and males Subjects with basic knowledge of primary education Subjects with mild cognitive impairment according to the ACE III scale with cut off score of 83 out of 100 and or MMSE reference values according to education level: illiterate less than 13 elementary or middle less than 18 and high education less than 26 out of 3o.
- •Subjects with minimum to no risk of falls according to Short FES cut-off score of 7 out of 28 Subjects having no prior history of neurological diseases and falling which could contribute to balance instability.
排除标准
- •Subjects taking medications affecting consciousness or indirectly cognitive system, Subjects with a history of other neurological conditions that may alter cognition, Subjects with any significantly diagnosed visual and auditory impairment, Presence of severe neurological disease or psychiatric illness such as mood disorders depression or anxiety, bipolar disease, etc, Non-cooperative subjects, Subjects who are involved in other routine physical activities, and Subjects with medical contraindications for making the necessary head movements during vestibular rehabilitation example Severe cervical disorder.
结局指标
主要结局
1. Electroencephalogram to study brain waveforms in terms of spectrum and coherence that correspond to different cognitive functions including attention memory reasoning information processing.
时间窗: Baseline assessment at 1st week before the commencement of trial. | At 8th week Post-intervention assessment. | At 10th week from the baseline follow up assessment.
2. P300 records an event-related potential and is used to analyze brain waveforms that correspond to attention memory and information processing.
时间窗: Baseline assessment at 1st week before the commencement of trial. | At 8th week Post-intervention assessment. | At 10th week from the baseline follow up assessment.
3. Digit symbol substitution test measures a range of cognitive operations and requires intact motor speed attention and visuo-perceptual functions.
时间窗: Baseline assessment at 1st week before the commencement of trial. | At 8th week Post-intervention assessment. | At 10th week from the baseline follow up assessment.
4. Digit symbol coding test WAIS-R is used to evaluate processing speed. It consists of 9 digit symbol pairs Under
时间窗: Baseline assessment at 1st week before the commencement of trial. | At 8th week Post-intervention assessment. | At 10th week from the baseline follow up assessment.
each digit the subject has to write down the related symbol as quickly as possible in 90 seconds.
时间窗: Baseline assessment at 1st week before the commencement of trial. | At 8th week Post-intervention assessment. | At 10th week from the baseline follow up assessment.
次要结局
- 1. The Stroop test assesses selective attention and inhibition.
研究者
Dr Majumi M Noohu
Jamia Millia Islamia