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临床试验/NCT03528993
NCT03528993已完成不适用

The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018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
发起方
入组人数
30
试验地点
1
主要终点
Berg balance scale

研究概览

简要总结

Stroke,one of the leading cause of death, is caused by ischemia or hemorrhage. It results in neurological deficits such as hemiplegia. Hemiplegia show disability characterized loss of motor, sensory and cognitive function. Reduced postural control and balance stability results gait disturbances such as asymmetric weight bearing, risk of falling and imbalances. It also shows increased energy expenditure, decreased independence on quality of life and limited mobility. Physical therapy can be effective method for solving these problems. Hippotherapy, also known as horseback riding therapy, is a form of physical therapy strategy that uses equine movement. The concept of hippotherapy is to use a horse as a therapeutic tool, and it is based on similarities in gait between the human and horse. The horse's gait provides patients having motor disabilities with rhythmic and repetitive movements similar to human walking, thereby giving them training opportunities to improve posture, balance, and strength. Even though it has many effect on solving these problems, hippotherapy centers are not enough. Due to climate and environmental situations, hippotherapy devices were improved and had similar effects on patients with stroke. In literature, these device mostly used on cerebral palsy, but investigator wants to use hippotherapy device on patient with Hemiplegia. For these reasons, the effects of exercises by mechanical hippotherapy device on postural control and balance will be investigated.

详细描述

Investigator will randomly allocate 30 patients with hemiplegia to two groups; Control group (n=15), experimental group(n=15).The control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks, while the experimental group receive conventional rehabilitation for 45 min/day following by use of a hippotherapy device for 15 min/day, 5 times/week for 4 weeks. Assessment procedure will be held at the beginning and 4th week of study. Assessment procedure will be held at the beginning and 4th week of study. All subjects will be assessed by berg balance scale and BIODEX primarily while Timed up and go test, SF-36, Functional reach test, functional independence measurement(FIM), Trunk Impairment Scale (TIS), Trunk Control Test (TCT), motricity index, Fugl-meyer will be held secondarily.

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 (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mini Mental Test score more than 24
  • Ability to stand and sit independently
  • Ability to follow and understand verbal instructions.

排除标准

  • Musculoskeletal problems
  • Neurologic deficits such as unilateral neglect, hemianopsia, and apraxia

研究组 & 干预措施

Exercise by hippotherapy device group

Experimental

The experimental group receive conventional rehabilitation for 45 min/day following by use of a hippotherapy device for 15 min/day, 5 times/week for 4 weeks

干预措施: exercise by hippotherapy device (Other)

Exercise by hippotherapy device group

Experimental

The experimental group receive conventional rehabilitation for 45 min/day following by use of a hippotherapy device for 15 min/day, 5 times/week for 4 weeks

干预措施: conventional rehabilitation (Other)

Control group

Other

The control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks.

干预措施: conventional rehabilitation (Other)

Control group

Other

The control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks.

干预措施: postural control exercises (Other)

结局指标

主要结局

Berg balance scale

时间窗: Change from baseline to week 4

The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. The BBS has been evaluated in several reliability studies. A recent study of the BBS, which was completed in Finland, indicates that a change of eight (8) BBS points is required to reveal a genuine change in function between two assessments among older people who are dependent in ADL and living in residential care facilities. 14-item scale designed to measure balance of the older adult in a clinical setting. Equipment needed: Ruler, two standard chairs (one with arm rests, one without), footstool or step, stopwatch or wristwatch, 15 ft walkway Completion Time: 15-20 minutes

BIODEX balance systems

时间窗: Change from baseline to week 4

Biodex Balance System (BBS), a commercially available balance device, Biodex Medical Systems, Shirley, NY, USA) will used to assess fall risk and balance. It consists of a movable balance platform which provides up to 20° of surface tilt in a 360° range of motion and the platform is interfaced with computer software (Upper display module-firmware version 1.09, Lower control board-firmware version 1.03, Biodex Medical Systems) that enables the device to serve as an objective assessment of balance and fall risk. The system had various difficulty levels which range from 1 (most difficult) to 12 (the easiest). two settings will be used to assess the dynamic balance and the fall risk;the postural stability test (PST) and the fall risk test (FRT).

次要结局

  • Timed Up and Go Test(Change from baseline to week 4)
  • SF-36 (The Short Form Health Survey)(Change from baseline to week 4)
  • Trunk Impairment Scale (TIS)(Change from baseline to week 4)
  • Functional Independence Measurement(FIM)(Change from baseline to week 4)
  • The Trunk Control Test (TCT)(Change from baseline to week 4)
  • Functional Reach Test(Change from baseline to week 4)
  • Fugl-Meyer Assessment of Motor Recovery after Stroke(Change from baseline to week 4)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

osman coban

PT, MSc

Istanbul Medipol University Hospital

研究点 (1)

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