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临床试验/NCT03500705
NCT03500705已完成不适用

Unilateral Strength Training and Mirror Therapy for Enhancing Upper Limb Motor Function Post Stroke: A Pilot Randomised Controlled Trial

Institute of Technology, Sligo1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年10月22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
35
试验地点
1
主要终点
Maximal Rate of Torque Development Isometric elbow extension strength.

研究概览

简要总结

This is a pilot randomised controlled trial investigating a combination of unilateral strength training (cross-education) and mirror therapy for the rehabilitation of upper 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 assessments being conducted at the institute and all therapy sessions taking place at the participant's home. 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 perform a strength training programme with their less-affected upper limb. The mirror and strength training group observed the reflection of the training limb in a mirror, the strength training only group exercised without a mirror entirely. 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 32 participants were recruited. After a warm-up participants performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb, 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 follow-up assessment. All assessments were carried out by a blinded Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for upper limb isometric strength, motor function, muscle tone, and self-perceived participation.

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
Single (Outcomes Assessor)

盲法说明

Outcome assessor only was masked.

入排标准

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

入选标准

  • •Chronic stroke diagnosed by a physician at least 6 months prior to study begin Discharged from formal rehabilitation services (not receiving outpatient rehabilitation on more than a monthly basis, but may still be in receipt of occupational or language therapy).

排除标准

  • •Impaired cognition (Mini mental state examination (MMSE) < 21) Cardiovascular, neurological or musculoskeletal impairments of the upper extremity not related to stroke that would prevent strength training.
  • •Visual impairments that would interfere with the ability to participate safely in isometric training and observe mirror images.

研究组 & 干预措施

Mirror Therapy + Cross-Education.

Experimental

Patients performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb (Cross-Education of Strengthening) while observing the reflection of the exercising limb in the mirror (Mirror Therapy) which was placed in the patient's mid-sagittal plane. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals.

干预措施: Mirror Therapy (Device)

Mirror Therapy + Cross-Education.

Experimental

Patients performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb (Cross-Education of Strengthening) while observing the reflection of the exercising limb in the mirror (Mirror Therapy) which was placed in the patient's mid-sagittal plane. Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals.

干预措施: Cross-Education of Strengthening. (Other)

Cross-Education of Strengthening.

Active Comparator

Patients trained without a mirror entirely. They performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb (Cross-Education of Strengthening). Training sessions took place 3 days per week for four weeks in the participant's own home under the supervision of 2 exercise professionals.

干预措施: Cross-Education of Strengthening. (Other)

结局指标

主要结局

Maximal Rate of Torque Development Isometric elbow extension strength.

时间窗: 10 minutes

Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Highest Rate of Torque Development out of 5 single isometric contraction was analysed. A higher rate of torque measurement indicates a greater contraction strength.

Maximal Peak Torque Isometric elbow extension strength.

时间窗: 10 minutes

Assessed with the Biodex System 3 Pro Isokinetic Dynamometer with the Biodex Advantage Software version 3.45 (Biodex Medical Systems, Inc., Shirley, New York, USA). Highest Peak Torque out of 5 single isometric contractions was analysed. A higher peak torque measurement indicates a greater contraction strength.

次要结局

  • Modified Ashworth Scale (MAS).(10 minutes.)
  • Chedoke Arm and Hand Activity Inventory - 8 Version(10 mins)
  • ABILHAND Questionnaire(10 mins)
  • London Handicap Scale (LHS).(10 minutes)

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 (1)

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