跳至主要内容
临床试验/NCT06137443
NCT06137443已完成不适用

Enhancing Balance and Mobility in Incomplete Spinal Cord Injury With an Overground Gait Trainer

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年1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
5
试验地点
2
主要终点
Berg Balance Scale

研究概览

简要总结

The goal of this clinical trial is to compare the effects of balance therapy with an overground gait trainer in incomplete spinal cord injury (SCI). The main questions it aims to answer are:

  • Is balance therapy with an overground gait trainer effective in improving functional ambulation in SCI?
  • Is balance therapy with an overground gait trainer effective in enhancing Activities of Daily Living in SCI?

Participants treated with either:

• Overground gait trainer along with conventional exercise therapy

详细描述

Background: Spinal Cord Injury (SCI) and similar pathologies not only negatively affect a person's ability to walk but also have adverse effects on their participation in social, vocational, and recreational activities. The correction of walking impairments resulting from SCI is one of the most important goals of rehabilitation, as it is essential for a person's social and vocational integration. When considering balance function, the use of challenging balance and walking exercises at an adequate level is necessary to trigger motor learning. Ensuring the patient's safety is the primary priority when using advanced balance and walking exercises based on the patient's current condition. In this study, Andago V2.0 (Hocoma AG, Volketswil, Switzerland) has been preferred for ensuring safety by adapting to patient movements. The main objective of the study was to assess the impact of Andago on balance in patients with motor incomplete SCI. The secondary aim was to evaluate its influence on quality of life and independence. Methods: The study included five participants who were over 18 years of age and had experienced a spinal injury within the past year. These participants were classified as AIS D (American Spinal Injury Association Impairment Scale). Patients underwent eight-week treatment, with walking and balance exercises on Andago performed three days a week. In addition, conventional in-bed exercises, including stretching, strengthening, and mobility exercises, were administered for 40 minutes, two days a week. Modified Borg Scale (MBS), Ten-Meter Walking Test (10MWT), Timed Up and Go Test (TUG), Walking Index in Spinal Cord Injury II (WISCI II), Berg Balance Scale (BBS), Visual Analogue Scale (VAS) for fear of falling, Spinal Cord Independence Measure (SCIM III), World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) were used for evaluation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Spinal Cord Injured below T4
  • Time from injury < 1 year
  • D level on AIS (American Spinal Injury Association Impairment Scale)
  • Patients with spinal stabilization

排除标准

  • Osteoporosis
  • An implanted electronic device
  • other neurological diseases
  • Cardio-pulmonary diseases
  • Orthopedic diseases

结局指标

主要结局

Berg Balance Scale

时间窗: 11 months

Berg Balance Scale for balance assessment

次要结局

  • Ten-Meter Walking Test(11 months)
  • Walking Index in Spinal Cord Injury II(11 months)
  • Visual Analogue Scale(11 months)
  • Timed Up and Go Test(11 months)
  • World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)(11 months)
  • Modified Borg Scale(11 months)
  • Spinal Cord Independence Measure (SCIM III)(11 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验