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临床试验/NCT05585424
NCT05585424已完成不适用

Effectiveness of a Program Based on Observation-action Training (AOT) on Motor, Functional and Cognitive Aspects in Patients With Cognitive Impairment.

Universidad Europea de Madrid1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Upper limb functionality measured with upper limb subsection of the Fugl Meyer scale

研究概览

简要总结

The objective of this study is to assess motor and social interaction changes after AOT intervention in patients with mild cognitive impairment and Moderate cognitive impairment.

The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Each group will be composed of eleven subjects with moderate cognitive impairment (MCI) and eleven with mild cognitive impairment (MCI), assessed by the minimental test. During the sessions, the MCI patient will observe his MCI partner and perform a programme of motor activities for the upper limb. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.

The activities will be based on items of the FUGL-MEYER scale. Data will be collected at the functional level, with respect to motor changes and also social modifications that have been perceived by the participants, carers and therapists.

The variables considered in this study are, as primary variables, motor changes, using the Fugl-Meyer scale, and perception with respect to social interaction; as well as mood. The latter two will be collected through interviews with patients, caregivers and therapists.

The impact on patient independence (Barthel index score) will also be considered. Finally, data will be analysed using SPSS statistical software. Non-parametric tests for related samples will be used in order to study changes in the variables collected before and after the intervention. The sample will be recruited from the old people's home "Nuestra Señora de la Soledad" in Parla, Madrid (collaboration agreement attached) depending on whether or not they meet the inclusion criteria.

详细描述

Previous work has demonstrated the effectiveness of observational learning. A previous study on children with cerebral palsy "Efficacy of a home-based platform for child-to-child interaction on hand motor function in unilateral cerebral palsy" presented by Naura, Avanzini, Rizzolatti and Fabbri-Destro, showed that motor learning by observation is greater and presents more evident benefits when subjects learn from other patients with the same condition and less severity than when they learn by observing the therapist or another person without motor impairment. This work seeks to measure the improvements, both motor, functional and social, that patients with cognitive impairment can achieve with such an intervention.

This work is an experimental study based on the stimulation of mirror neurons. The planned sample size is 11 pairs in the experimental group and 11 pairs in the control group. Each group will be composed of eleven subjects with moderate cognitive impairment (MCI) and eleven with mild cognitive impairment (MCI), assessed by the minimental test. During the sessions, the MCI patient will observe his MCI partner and perform a programme of motor activities for the upper limb. At the same time the mild patient imitates the movement performed by the physiotherapist, all based on the AOT.

The activities will be based on items of the FUGL-MEYER scale. The sessions will last between 15 and 20 minutes and will be held three days a week. The intervention will last 5 weeks, with an initial assessment, 11 intervention sessions and a final assessment.

Inclusion criteria are: institutionalised patients over 65 years of age with mild cognitive impairment (minimental test between 19 and 23) or moderate cognitive impairment (minimental test 14-18); patients who perform physiotherapy exercises twice a week or attend occupational therapy twice a week; patients supervised by geriatric assistants or nurses during basic activities of daily living.

Exclusion criteria are considered to be: patients with musculoskeletal and neuro-musculoskeletal pathology of the dominant upper limb (outside MCI and MCI); presentation of visual deficit not correctable with glasses; patients with aggressive behavioural alterations or emotional lability; presentation of severe hypoacusis not correctable with hearing aids.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •Institutionalised patients over 65 years of age.
  • •Mild cognitive impairment (minimental test between 19 and 23) or moderate cognitive impairment (minimental test 14-18);
  • •Patients supervised by geriatric or nursing assistants during basic activities of daily living

排除标准

  • •Patients with musculoskeletal and neuro-musculoskeletal pathology of the dominant upper limb (outside MCI and MCI);
  • •Presentation of visual deficit not correctable with glasses;
  • •Patient with aggressive behavioural disturbance or emotional lability;
  • •Patient with severe hypoacusis not correctable with hearing aids.

研究组 & 干预措施

Experimental Group

Experimental

Patients in the experimental group were paired so that each patient with MCI faced a patient with ModCI. During the sessions, two therapists performed the upper limb activities that only the MCI patients could see and they performed them by imitation

干预措施: AOT intervention (Other)

Control group

No Intervention

The CG was assessed at baseline and after one month and continued with their usual activities in the nursing home.

结局指标

主要结局

Upper limb functionality measured with upper limb subsection of the Fugl Meyer scale

时间窗: one month

The upper limb subsection has 33 items, with the maximum score of 66 being associated with the best upper limb motor function and 0 being the minimum score

Independence in activities of daily living measured with Barthel Índex

时间窗: one month

here are 10 items that add up to 5 or 10 points and total up to a maximum of 100 when the person is independent in BADLs

Cognitive impairment measured with Mini-Mental State Examination (MMSE)

时间窗: one month

The MMSE assesses different cognitive functions (orientation, memory, attention and calculation, language, construction, praxis and reasoning). The maximum score is 30. A score of 23 or lower is associated with cognitive impairment.

次要结局

未报告次要终点

研究者

发起方
Universidad Europea de Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Estrada Barranco

PhD in health sciences

Universidad Europea de Madrid

研究点 (1)

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