The Effectiveness of Cognitive Rehabilitation Intervention With the Telerehabilitation Method for Amnestic Mild Cognitive Impairment: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
研究概览
简要总结
Different cognitive rehabilitation intervention methods have been developed for the treatment of cognitive dysfunctions seen in mild cognitive impairment (MCI). The aim of this study was to examine the effectiveness of cognitive rehabilitation intervention applied with the telerehabilitation method in elderly patients with amnestic-MCI.
Participants included in the study according to inclusion and exclusion criteria were randomly assigned to the telerehabilitation and face-to-face groups. A 12-week cognitive rehabilitation intervention was applied to both groups. Pre- and post-intervention cognitive skills of the participants were evaluated using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G).
详细描述
A single-blinded, feasibility randomized controlled trial (RCT) investigated changes in the cognitive functions of older adults with amnestic-MCI after CR interventions applied face-to-face and with telerehabilitation. The study was designed according to the CONSORT statement. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.
The demographic characteristics of the participants were recorded, including age, sex, education level, and marital status. All participants underwent a cognitive function assessment using the Loewenstein Occupational Therapy Cognitive Assessment-Geriatric twice, once before the intervention and again after the 12-week intervention. All participants were assessed in occupational therapy clinical practice units.
Participants were randomized to either the Face-to-Face group (FF) or the Tele-rehabilitation group (TR) using a computer-generated randomization technique.
After the randomization, cognitive rehabilitation intervention for both methods consist of 45-minute twice a week for 12 weeks. All participants received the intervention individually.
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 (Outcomes Assessor)
盲法说明
The investigator who evaluated the cases was blinded from the study.
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 and 75 years
- •Diagnosed with amnestic-MCI by medical doctors
- •Access to technological equipment; and
- •Ability to understand and follow verbal instructions.
排除标准
- •Secondary chronic disease that may affect cognitive functioning;
- •Auditory and visual problems that may affect rehabilitation implementation and communication; and
- •Attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period.
结局指标
主要结局
The Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
时间窗: after the 12-week intervention program
The LOTCA-G, which was created to evaluate cognitive functions in the elderly. This test evaluates 8 cognitive domains with 24 items: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, thinking operations, attention/concentration, and memory. The items in each subtest are evaluated on an ordered scale from 1 to 4 (excluding the orientation items scored from 1 to 8). A higher test score indicates better cognitive performance. The LOTCA-G can differentiate healthy older adults from those with dementia and MCI. It is sensitive to dementia levels and identifies changes over time. The LOTCA-G was used to evaluate the effectiveness of cognitive rehabilitation intervention both face-to-face and with tele-rehabilitation method. It was planned to evaluate the effectiveness of the intervention, which consisted of a total of 24 sessions of 12 weeks, by making a total of two evaluations before and after the treatment.
次要结局
未报告次要终点
研究者
Berkan Torpil, PhD
Associate professor
Saglik Bilimleri Universitesi