跳至主要内容
临床试验/NCT06496529
NCT06496529招募中不适用

ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke

University of Chile4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
4
主要终点
Change in UE-FMA at the end of the training

研究概览

简要总结

Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution.
  • Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction and finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).

排除标准

  • Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA < 18).
  • Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS > 6) or having limited reach ranges.
  • Have severe visual impairment that does not allow to carry out the activities associated with the task.
  • Previous stroke with neurological sequelae in the upper extremity.
  • Present bilateral sensorimotor alterations.
  • Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)

结局指标

主要结局

Change in UE-FMA at the end of the training

时间窗: 3 days post training

Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training

Change in UE-FMA at 6 months post stroke

时间窗: 180 days post stroke

Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke

Change in UE-FMA at the end of the training

时间窗: 3 days post training

Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training

Change in UE-FMA at 6 months post stroke

时间窗: 180 days post stroke

Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke

次要结局

  • Change in ARAT at the end of the training(3 days post training)
  • Change in ARAT at 6 months post stroke(180 days post stroke)
  • Change in iCoh at the end of the training(3 days post training)
  • Change in iCoh connectivity at 6 months post stroke(180 days post stroke)
  • Change in arm kinematics at the end of the training(3 days post training)
  • Change in arm kinematics at 6 months post stroke(180 days post stroke)
  • Change in ARAT at the end of the training(3 days post training)
  • Change in ARAT at 6 months post stroke(180 days post stroke)
  • Change in iCoh connectivity at 6 months post stroke(180 days post stroke)
  • Change in arm kinematics at the end of the training(3 days post training)
  • Change in arm kinematics at 6 months post stroke(180 days post stroke)
  • Change in iCoh at the end of the training(3 days post training)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Burgos

Principal Investigator. Ph.D, PT.

University of Chile

研究点 (4)

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