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临床试验/NCT07240129
NCT07240129已完成不适用

Effect of Graded Motor Imagery on Shoulder Dysfunction Post Mastectomy

Cairo University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年6月30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
入组人数
54
试验地点
1
主要终点
Visual analog scale

研究概览

简要总结

One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery.

Graded motor imagery is effective in reducing pain interference with function using a graded sequence of strategies including left/right judgements (implicit motor imagery), imagined movements (explicit motor imagery) and mirror therapy.

详细描述

54 female patients who have shoulder dysfunction post-mastectomy will participate in this study. Their ages will be ranged 35 to 55 years.

In this study the patients will be randomly assigned into two equal groups (27 patients for each group):

  1. Group A (study group):

This group includes 27 patients who will receive graded motor imagery (GMI) along with the conventional physiotherapy (It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises). GMI is consists of a three-step process. Each step of will be carried out for two weeks, for 30 minutes on two separate days, for total 6 weeks. 2. Group B (control group):

This group includes 27 patients who will receive conventional physiotherapy treatment. It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises, 2 times / week for 6 weeks.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double blind study design. Randomization and masking were performed by an independent investigator who was not engaged in either the treatment administration or the outcome assessment

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age range of 35 to 55 years.
  • •All patients are post-mastectomized unilaterally.
  • •Female patients only.
  • •Patients have shoulder ROM restriction.
  • •Patients have shoulder pain more than 3 months (chronic).

排除标准

  • •Having double mastectomy.
  • •Psychopathological disorders.
  • •Having other orthopedic problems (e.g. tendinitis, dislocation, osteoarthritis, referred pain to shoulder).
  • •Motor problems (e.g. tremor, dyskinesia).
  • •Metastasis.
  • •Visual impairment such that they could not read unaided or with their reading glasses.
  • •Having previously received GMI treatment.
  • •Diabetes mellitus.
  • •Having neurological problems as hemiplegia.
  • •Patients with lymphedema

研究组 & 干预措施

Group A (study group)

Active Comparator

This group includes 27 patients who will receive graded motor imagery (GMI) along with the conventional physiotherapy (It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises). GMI is consists of a three-step process. Each step of will be carried out for two weeks, for 30 minutes on two separate days, for total 6 weeks

干预措施: Graded Motor Imagery (GMI) (Other)

Group A (study group)

Active Comparator

This group includes 27 patients who will receive graded motor imagery (GMI) along with the conventional physiotherapy (It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises). GMI is consists of a three-step process. Each step of will be carried out for two weeks, for 30 minutes on two separate days, for total 6 weeks

干预措施: Physical therapy program (Other)

Group B (control group)

Placebo Comparator

This group includes 27 patients who will receive conventional physiotherapy treatment. It will include exercise like codman's pendulum exercises in flexion-extension, abduction-adduction, and circular motion, active assisted ROM exercises with a wand, capsular stretching, wall ladder, and shoulder wheel exercises, 2 times / week for 6 weeks

干预措施: Physical therapy program (Other)

结局指标

主要结局

Visual analog scale

时间窗: From baseline to 6 weeks

A validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 means "no pain" and 10 means "worst pain."

Smartphone clinometer application

时间窗: From baseline to 6 weeks

The smartphone clinometer application has excellent agreement with a goniometer-based gold standard for measurement of shoulder ROM in both healthy subjects and symptomatic patients.

次要结局

  • Shoulder Pain and Disability Index(From baseline to 6 weeks)
  • Handheld dynamometer(From baseline to 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Abdallah Mohamed

Assistant lecturer

Cairo University

研究点 (1)

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