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临床试验/NCT04166617
NCT04166617Unknown不适用

Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Jamar

研究概览

简要总结

The affectedness of the motor control of the upper limb, particulary, the hand and/or fingers, appears in many neurological diseases, what is going to impact on the functionality of the subject. The use of new technologies in the rehabilitation environment, has the target to reduce the impact on the disabling conditions. So that, the goal of this investigation is to evaluate the system use effectiveness of the Leap Motion Controller® in the treatment on the upper limb on patients with neurological disease.

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 (Investigator)

入排标准

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

入选标准

  • •people aged between 30 and 70 years old;
  • •with a confirmed diagnosis of brain damage (>6 months);
  • •UL motor impairment with a Fugl-Meyer score≥16;
  • •a modified Ashworth scale score≤2 in the deltoid, triceps brachii, biceps brachii and in the wrist and finger flexor and extensor muscles of the upper limb

排除标准

  • •the inability to understand instructions and actively cooperate in the tasks indicated based on a score ≥ 24 in the Mini-mental Test;
  • •refusal to participate in the study;
  • •visual impairment not correctable by glasses.

研究组 & 干预措施

Conventional therapy

Active Comparator

Conventional physical therapy for upper limb in stroke patients

干预措施: Conventional therapy (Other)

Leap motion plus conventional therapy

Experimental

Leap motion plus conventional physical therapy for upper limb in stroke patients

干预措施: Leap motion plus conventional therapya (Other)

结局指标

主要结局

Jamar

时间窗: 8 weeks

Jamar® hydraulic hand dynamometer was used to measure grip strength.

Action Research Arm Test (ARAT)

时间窗: 8 weeks

Shoulder Pain - Physioplus Objective The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning)

Box and blocks

时间窗: 8 weeks

Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side.

次要结局

  • Adherence to the therapy sessions(8 weeks)
  • Questionary of Patient Satifaction(8 weeks)

研究者

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

Josue Fernandez Carnero

Full proffesor

Universidad Rey Juan Carlos

研究点 (1)

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