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临床试验/NCT05559385
NCT05559385已完成不适用

Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke

Emresenocak2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
2
主要终点
Fugl-Meyer Upper Extremity Assessment:

研究概览

简要总结

The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR).

A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).

详细描述

Assessments:

  • Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity.

  • Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position.

  • Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study.

  • Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).

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
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-85 years and having had a stroke in the last six months,
  • Mini-Mental State Assessment score >20,
  • Able to sit safely,
  • No neglect issue,
  • Fugl-Meyer Upper Extremity Assessment score <58.

排除标准

  • Modified Ashworth Scale >2,
  • Severe reduction in visual acuity,
  • Participation in another rehabilitation program,
  • Subluxation or pain in the shoulder region.

结局指标

主要结局

Fugl-Meyer Upper Extremity Assessment:

时间窗: At the end of the 6th week

This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.

次要结局

  • Trunk Impairment Scale(At the end of the 6th week)
  • Demographic Data Form(At the baseline)
  • - Wolf Motor Function Test:(At the end of the 6th week)

研究者

发起方
Emresenocak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emresenocak

Research Assisstant

Marmara University

研究点 (2)

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