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临床试验/NCT05552742
NCT05552742已完成不适用

Comparison of The Effects of Virtual Balance Training and Conservative Rehabilitation Therapy on Balance in Stroke Patients.

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年11月1日最近更新:
适应症

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
Berg Balance Scale

研究概览

简要总结

The study aimed to assess the effects of a virtual balance training program using the Thera-Trainer Balo (TTB) device along with conservative rehabilitation program on the clinical findings; standing, stepping, walking and balance measures; and activities of daily living in patients with stroke.

详细描述

Stroke is one of the leading causes of death and disability worldwide. Approximately 71% of stroke cases occur as a result of ischemic infarcts. Most survivors of stroke experience gait and balance disorders that increase the risk of falling.

It has been shown that the functional recovery of patients with stroke is adversely affected and length of hospital stay during the rehabilitation program, particularly in those with severe balance disorders.

Virtual reality technologies are currently employed to accelerate functional recovery in patients.

A total of 30 patients were included in the study. The patients were randomized into two groups with 15 patients in each group by simple randomization.

Group 1 received the conservative rehabilitation program, whereas Group 2 received a balance training program using the Thera-Trainer Balo (TTB) device along with the conservative rehabilitation program.

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)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who had a cerebrovascular accident at least 6 months before the study,
  • patients had the first unilateral hemiparesis attack, could stand with or without assistance,
  • patients had no contraindications for walking.

排除标准

  • patients with a history of neurological diseases,
  • a mini-mental test score of <24,
  • severe spasticity at the lower extremity with grade 4 and unilateral neglect, and musculoskeletal diseases such as amputation and severe arthritis, which limits walking,

结局指标

主要结局

Berg Balance Scale

时间窗: 8 Week After Treatment

The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning

Static and Dynamic Postural Stability Tests

时间窗: 8 Week After Treatment

In the static postural stability test, two-legged standing, tandem standing, two-legged standing on a foam mat, tandem standing on a foam mat, one-legged standing, turning head and stopping on one leg, and one-legged standing on a foam mat were evaluated. The tasks of walking 25 steps on a foam mat and walking 25 steps on hard smooth ground were evaluated in dynamic postural stability test.

Functional Ambulation Scale

时间窗: 8 Week After Treatment

Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.

次要结局

  • Brunnstrom Stages(8 Week After Treatment)
  • The Modified Ashworth Scale(8 Week After Treatment)
  • Short Form-36 Quality of Life Scale(8 Week After Treatment)

研究者

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

Serdar Kilinc

Assistant Professor

Abant Izzet Baysal University

研究点 (2)

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