跳至主要内容
临床试验/NCT03468504
NCT03468504已完成不适用

Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial

Institute of Technology, Sligo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4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
入组人数
30
试验地点
2
主要终点
Ten Metre Walk Test

研究概览

简要总结

This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

详细描述

The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.

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

Experimental Group saw mirror image of non-affected limb in mirror while walking on treadmill.

Placebo Group saw no refection of the non-affected limb due to positioning of mirror while walking on treadmill.

Outcome assessor was blinded to treatment allocation. They evaluated participants in separate lab and was asked not to discuss the treatment given to patients. Even if the patient mentioned the trials they would discuss the fact that they were using Mirrors and Treadmill.

入排标准

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

入选标准

  • Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis.
  • Ambulatory with/without walking aid.
  • Discharged from formal rehabilitation.
  • A Mini Mental State Examination >/= 24.

排除标准

  • Younger than 18 years
  • Any additional illness that may prevent treadmill walking
  • A Mini Mental State Examination < 24.

研究组 & 干预措施

Mirror Therapy & Treadmill Training

Experimental

Mirror Therapy: Participants view a mirror reflection of their non-affected limb which is placed in their mid-sagittal plane for 30 mins per day, 3 days per week, for four weeks.

Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

干预措施: Mirror Therapy (Device)

Mirror Therapy & Treadmill Training

Experimental

Mirror Therapy: Participants view a mirror reflection of their non-affected limb which is placed in their mid-sagittal plane for 30 mins per day, 3 days per week, for four weeks.

Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

干预措施: Treadmill (Device)

Placebo Mirror & Treadmill Training

Placebo Comparator

Placebo Mirror Therapy: Participants view a mirror which is placed forward/ahead of them in their mid-sagittal plane, and cannot see a reflection of any lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.

Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

干预措施: Placebo Mirror Therapy (Device)

Placebo Mirror & Treadmill Training

Placebo Comparator

Placebo Mirror Therapy: Participants view a mirror which is placed forward/ahead of them in their mid-sagittal plane, and cannot see a reflection of any lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.

Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.

干预措施: Treadmill (Device)

结局指标

主要结局

Ten Metre Walk Test

时间窗: 5 mins.

Walking velocity measure. Lower times indicate an increased walking velocity.

Six Minute Walk Test

时间窗: 10 mins

Walking endurance measure. Larger distance indicates an improved walking endurance ability.

次要结局

  • Modified Ashworth Scale(10 minutes)
  • Fugl-Meyer Assessment-Lower extremity(10 mins)

研究者

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

Dr. John Bartlett

Head of Research

Institute of Technology, Sligo

研究点 (2)

Loading locations...

相似试验

Mirror Therapy and Treadmill Training for Patients... | 临床试验