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临床试验/NCT04166279
NCT04166279已完成不适用

The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols in Comparison

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement

研究概览

简要总结

This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.

详细描述

Breast cancer (BC) is the most common cancer in women in the developed world. Surgery and medical protocols have improved significantly over the last 10 years and this guarantees a better chance of survival and an improvement in quality of life.

Then, the focus on "what happen after defeating BC" has become current: patients' and physicians' awareness of the sequelae of BC surgery has increased, especially in the case of mastectomy or modified radical mastectomy. A large number of these complications, such as lymphedema or post-treatment pain with or without functional impotence, which contribute to limitations in daily life activities, can be treated favourably and, in sometimes, resolved with early rehabilitation protocols. Therefore, it is not only important to start the rehabilitation process early after surgery, but, also, during the sub-acute phase, choose appropriate exercise programs to allow recovery in "quantity" and "quality" of the movement of the operated upper limb (UL). Alterations in muscle activation and reduced shoulder mobility are common in patients with BC. It is necessary to consider that winged scapula incidence in BC surgery is 8% and the prevalence decreased during 6 months after surgery. In particular, patients who developed winged scapula had more shoulder flexion, adduction and abduction limitation. These findings suggest that, after BC surgery, soft tissues restrictions obstruct short-term scapula motion.

Reaching movement is a complex multi-articular movement towards a defined point in space and allows the hand to interact with the environment. Nevertheless, it is not yet investigated during the rehabilitation process. Moreover, the execution of the UL movements, improves if the numerous perturbations of the musculoskeletal system, which occur during the execution of movements, are compensated. Motor synergy's components should modify their action to influence positively the outcome of motor activity, preventing the mistakes of the individual components from influencing the overall activity. An important issue is represented by the redundancy of the degrees of motor freedom. Actions and movements can be performed in different ways because the functional synergies are able to co-vary, without changing the result of the action. However, only three spatial dimensions are needed to specify any position where the hand could be placed. This excess of kinematic degrees of freedom means that there are multiple arm configurations that correspond to any particular position of the hand. Thus, improvements in reaching, after BC mastectomy, can be determined, compared to a different rehabilitation protocol, by comparing the Single rehabilitative Treatment (ST) with Group Treatment (GT). Authors designed a randomized-controlled trial to check if specific scapula exercises, included in the ST, could induce changes in the fluidity of the reaching, called Jerk (primary outcome), decrease shoulder pain and improve the functioning of the operated upper limb (secondary outcomes).

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
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • total mastectomy carried out 12 months prior to recruitment for rehabilitation with breast prostheses or tissue expanders performed
  • age from 18 to 60 years
  • body mass index (BMI) < 30
  • no cognitive dysfunctions ( Mini Mental State Examination MMSE > 24)

排除标准

  • presence of lymphangitis or mastitis
  • presence of metastasis
  • surgical complications
  • neurological deficits
  • shoulder joint problems before surgery
  • severe-moderate lymphedema and web axillary syndrome
  • visual problem not corrected by lenses

结局指标

主要结局

Change [over time] of the normalized jerk (NJ) within biomechanical reaching movement

时间窗: T0 baseline - T1 (6 weeks) - T2 (3 months)

The normalized jerk (NJ) was evaluated through the Smart D500 stereo-photogrammetric system (BTS, Italy), calculated on the wrist-target marker distance, within the reaching task performed on the side underwent surgery. It measures the fluidity of the upper limb movement.

次要结局

  • Change [over time] of Visual Analogue Scale (VAS)(T0 baseline - T1 (6 weeks) - T2 (3 months))
  • Change [over time] of Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)(T0 baseline - T1 (6 weeks) - T2 (3 months))
  • Change [over time] of Movement Duration (MD) of biomechanical reaching movement(T0 baseline - T1 (6 weeks) - T2 (3 months))
  • Change [over time] of the angle of arm flexion at end of movement (AAF) within biomechanical reaching movement(T0 baseline - T1 (6 weeks) - T2 (3 months))
  • Change [over time] of the angle at elbow at end of movement (AE) within biomechanical reaching movement(T0 baseline - T1 (6 weeks) - T2 (3 months))
  • Change [over time] of the mean value of target-approaching velocity (TAV) within biomechanical reaching movement(T0 baseline - T1 (6 weeks) - T2 (3 months))

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Paolucci

Medical Doctor, PhD

University of Roma La Sapienza

研究点 (2)

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