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临床试验/NCT06137456
NCT06137456已完成不适用

First Report of a New Exoskeleton in Incomplete Spinal Cord Injury: FreeGait®

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 14 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
14
试验地点
2
主要终点
Walking Index in Spinal Cord Injury II

研究概览

简要总结

The goal of this clinical trial is to compare the effects of exoskeletal robotic therapy and conventional exercise therapy in incomplete spinal cord injury (SCI). The main questions it aims to answer are:

  • Is exoskeletal robotic therapy effective in improving functional ambulation in SCI?
  • Is exoskeletal robotic therapy effective in enhancing Activities of Daily Living in SCI?

Participants treated with either:

  • Exoskeletal robotic therapy along with conventional exercise therapy, or
  • Only conventional exercise therapy.

详细描述

Background: Intensive walking practice is a task that requires performance above the limits of conventional therapy. As a solution, robot-assisted exoskeletons that allow walking on the ground are produced. The exoskeletons can allow the user to perform intense, targeted, and multi-repetitive movements and at the same time provide stability and balance during walking. In this study, a new robot-supported exoskeleton system was used for gait and balance rehabilitation. This study is important as the first clinical study of a new walking system. The primary aim of the study was to evaluate the effect of the FreeGait® exoskeleton system (BAMA Technology, Ankara, Türkiye) on gait parameters in patients with motor incomplete spinal cord injury. The secondary aim was to assess its impact on quality of life and independence.

Methods: Fourteen participants with incomplete spinal cord injury were included in the study. An average of 20.7 sessions of exoskeleton therapy was administered to the study group. Gait training was attempted to be diversified as much as possible during the exoskeleton training. 10MWT, Timed Up and Go Test (TUG), 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.

Results: WISCI II levels improved significantly in the study group (p = 0.031). Overground walking speed means calculated from 10MWT increased by 66%, twofold compared to the control group (p = 0.016, p = 0.063, respectively). The mobility subscale of SCIM III, the total SCIM III scores, and the WHOQOL-BREF physical health domain score increased significantly, contrary to the control group (p < 0.05). However, there was no difference in the mean change of all measurements between groups (p > 0.05).

Conclusions: Gait training with the new exoskeleton system contributes to functional walking skills. It is possible that the residual motor learning ability, together with the balance and compensation mechanisms, played a role in the outcome. It is also important that this improvement in functional mobility is reflected in ADLs. It can be supposed that walking in different patterns, and speeds gives a way to simulate daily living conditions, which is the basis of the achievements in this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • SCI below T4,
  • Patients with AIS (American Spinal Injury Association Impairment Scale) C or D injury,
  • Bilateral quadriceps femoris manual test scores ≥ 2,
  • Upper extremity manual muscle test scores = 5,
  • Participants with adequate spinal stabilization

排除标准

  • Severe spasticity (Modified Ashworth Scale ≥ 3),
  • Difference in leg length,
  • Pregnancy, osteoporosis,
  • Contracture, or limited range of motion

结局指标

主要结局

Walking Index in Spinal Cord Injury II

时间窗: 23 months

Walking Index in Spinal Cord Injury II for walking independence level assessment

次要结局

  • World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)(23 months)
  • Timed Up and Go Test(23 months)
  • Visual Analogue Scale(23 months)
  • Spinal Cord Independence Measure (SCIM III)(23 months)
  • Berg Balance Scale(23 months)
  • Ten-Meter Walking Test(23 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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