跳至主要内容
临床试验/NCT07067710
NCT07067710招募中不适用

Effectiveness of Combined Motor Imagery and Action Observation in Improving Pain, Range of Motion, and Upper Limb Lymphedema in Breast Cancer Survivors. Efectividad de Las Terapias de imaginería Motora y observación de la acción en la Mejora Del Dolor, la Movilidad y el Linfedema de la Extremidad Superior en Supervivientes de cáncer de Mama.

Fundacion Miguel Servet2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
108
试验地点
2
主要终点
Sthrength

研究概览

简要总结

The aim of this study is to evaluate the effectivity of the combined motor imagery and action observation therapies to improve functional parameters such as strenght, range of motion, pain or fear of movements among others in relation to upper limb in breast cancer survivors. The main question it aims to answer is: Will a combined therapy of motor imagery and action observation improve the strenght, rang of motion, pain, limb diameter and fear of movement of the upper limb in breast cancer survivor females? The participants will be part of the IM-OA23 proyect that consist on seeing some diferent videos about upper limb mobility and then they'll have to imagine the movements and to performed themselves. Researches will compare two groups (control group and intervention group) to evaluate the diferences between them.

详细描述

Purpose: The aim of this study is to evaluate the effectivity of a combined motor imagery and action observation protocol at strength, range of motion, limb diamter, and fear of movement of the upper limb of breast cancer survivors.

Methods: A randomised controlled clinical trial will be conducted. Subjects will be randomly assigned to the two randomly assigned to the two treatment groups: intervention (IM-OA23 programme) and control group (usual care).

This study will have pre and post measurements. The intervention consist on a display of diferent videos of upper limb movements and at daily living activities and in a excercise of imagine and doing this movements. The're will be used diferent tools such as a dynamometer, a goniometer, Visual Analogue Scale (VAS) of pain, or TSK questionnaire.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female, over 18 years, have suffered breast cancer, have ended active treatments (chemotherapy, radiotherapy, surgery), have pain or functional limitation or lymphedema at upper limb afected.

排除标准

  • •males, people with active treatments ongoning, other types of cancer, recurrence or metastasis of cancer

研究组 & 干预措施

IMOA group

Experimental

The intervention group will participate in the IM-OA23 programme; the combination of motor imagery and action observation therapies.

干预措施: Motor imagery combined with action observation (Other)

Control group

No Intervention

The control group will follow the usual care from primary care. There are no care programmes for long term cancer survivors.

结局指标

主要结局

Sthrength

时间窗: From enrollement to the end of the treatment at 6 weeks and 3 month after

The grip strength of the hand of the affected limb shall be studied, using a dynamometer.

Range of Motion

时间窗: From enrollement to the end of the treatment at 6 weeks and 3 month after

The measurement of the degrees of movement of the shoulder joint by means of a goniometer. The movements of flexion, abduction and internal and external rotation shall be studied using previously established reference points. external rotation, using previously established reference points

Pain intensity

时间窗: From enrollement to the end of the treatment at 6 weeks and 3 month after

Pain intensity will be measured by Visual Analogue Scale (VAS). Participants will have to score their pain on a range from 0 to 10 where 0 means "no pain at all" and 10 "my pain is as bas as it could possibly be".

Limb diameter

时间窗: From enrollement to the end of the treatment at 6 weeks and 3 month after

Limb diameter will be measured by a measuring tape. The measurement is taken at the midpoint between the acromion and the olecranon, the tape being perpendicular to the limb without compressing the area. The midpoint is located with an elbow flexion of 90 degrees and then the measurement is taken with the elbow in extension, the result is expressed in centimetres.

Fear of movement

时间窗: From enrollement to the end of the treatment at 6 weeks and 3 month after

Fear of movement will be measured by the TSK questionnaire

Imagery

时间窗: From enrollement to the end of the treatment at 6 weeks and 3 month after

Imagery will be assessed using the Movement Imagery Questionnaire revised second edition (MIQ-RS)

次要结局

未报告次要终点

研究者

发起方
Fundacion Miguel Servet
申办方类型
Other
责任方
Sponsor

研究点 (2)

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